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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00379769
Registration number
NCT00379769
Ethics application status
Date submitted
21/09/2006
Date registered
22/09/2006
Date last updated
23/03/2017
Titles & IDs
Public title
RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes
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Scientific title
A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulfonylurea With Metformin Plus Sulfonylurea on Cardiovascular Endpoints and Glycaemia
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Secondary ID [1]
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BRL-049653/231
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Universal Trial Number (UTN)
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Trial acronym
RECORD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rosiglitazone
Treatment: Drugs - Sulfonylurea
Treatment: Drugs - Metformin
Experimental: rosiglitazone in addition to background metformin - Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Experimental: rosiglitazone in addition to background sulfonylurea - Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Active Comparator: Sulfonylurea in addition to background metformin - Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Active Comparator: Metformin in addition to background sulfonylurea - Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Treatment: Drugs: Rosiglitazone
Rosiglitazone maximum 8 mg per day
Treatment: Drugs: Sulfonylurea
Sulfonylurea (SU) maximum permitted daily dose
Treatment: Drugs: Metformin
Metformin maximum permitted daily dose .
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events
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Assessment method [1]
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The number of participants with cardiovascular death events (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation events (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) was recorded.
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Timepoint [1]
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Baseline through End of Study (up to 7.5 years)
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Primary outcome [2]
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Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause
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Assessment method [2]
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All deaths identified during the original record study and discovered after the re-adjudication efforts began were included.
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Timepoint [2]
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Baseline through End of Study (up to 7.5 years)
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Primary outcome [3]
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Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions
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Assessment method [3]
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IR was based on original RECORD endpoint definitions. CV death= no unequivocal non-CV cause (sudden death, death from acute vascular events, heart failure, acute MI, other CV causes, and deaths adjudicated as unknown cause). MI event=hospitalization + elevation of specific cardiac biomarkers above the upper limit of normal + cardiac ischemia symptoms/new pathological electrocardiogram findings. Stroke event=hospitalization + rapidly developed clinical signs of focal/global disturbance of cerebral function for more than 24 hours, with no apparent cause other than a vascular origin.
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Timepoint [3]
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Baseline through End of Study (up to 7.5 years)
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Primary outcome [4]
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Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions
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Assessment method [4]
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Independent re-adjudication was based on the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions. CV death included death resulting from an acute MI; sudden cardiac death and death due to heart failure, stroke, and to other CV causes. Deaths of unknown cause were counted as CV deaths. MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.
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Timepoint [4]
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Baseline through End of Study (up to 7.5 years)
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Primary outcome [5]
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Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions
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Assessment method [5]
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The number of participants with a CV death (or unknown) as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. CV death was defined as any death for which an unequivocal non-CV cause could not be established. CV death included death following heart failure, death following acute myocardial infarction (MI), sudden death, death due to acute vascular events, and other CV causes. Deaths due to unknown causes were classified as "unknown deaths," but were counted as CV deaths for the analysis of this endpoint.
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Timepoint [5]
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Baseline through End of Study (up to 7.5 years)
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Primary outcome [6]
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Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions
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Assessment method [6]
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The number of participants with a CV (or unknown) death as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. CV death included death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, and death due to other CV causes. Deaths of unknown cause were counted as CV deaths.
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Timepoint [6]
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Baseline through End of Study (up to 7.5 years)
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Primary outcome [7]
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Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions
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Assessment method [7]
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The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. An event of MI was defined as hospitalization plus elevation of cardiac biomarkers troponin (TN) I and/or TNT above the upper limit of normal (ULN) or creatinine kinase (CK) MB (M=muscle type; B=brain type) isoenzyme >= 2x the ULN or CK > 2x the ULN plus typical symptoms of cardiac ischemia or new pathological electrocardiogram findings, or cause of death adjudicated as MI.
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Timepoint [7]
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Baseline through End of Study (up to 7.5 years)
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Primary outcome [8]
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Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions
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Assessment method [8]
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The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
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Timepoint [8]
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Baseline through End of Study (up to 7.5 years)
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Primary outcome [9]
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Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions
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Assessment method [9]
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Par. with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. A stroke event=hospitalization plus rapidly developed clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours (unless interrupted by thrombolysis, surgery, or death), with no apparent cause other than a vascular origin, including par. presenting clinical signs/symptoms suggestive of subarachnoid haemorrhage/intracerebral haemorrhage/cerebral ischemic necrosis or cause of death adjudicated as stroke.
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Timepoint [9]
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Baseline through End of Study (up to 7.5 years)
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Primary outcome [10]
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Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions
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Assessment method [10]
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The number of participants with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.
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Timepoint [10]
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Baseline through End of Study (up to 7.5 years)
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Secondary outcome [1]
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Number of Participants With Cardiovascular Events and All-cause Deaths
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Assessment method [1]
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Composites of participants with first cardiovascular (CV) hospitalisations and CV death or all-cause death and individual first events of acute myocardial infarction (MI) , stroke, congestive heart failure (CHF), CV death, and all-cause death.
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Timepoint [1]
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Baseline through End of Study (up to 7.5 years)
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Secondary outcome [2]
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Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths
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Assessment method [2]
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The total number of events for individual components of cardiovascular (CV) hospitalisations and cardiovascular deaths were recorded. MI, myocardial infarction.
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Timepoint [2]
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Baseline through End of Study (up to 7.5 years)
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Secondary outcome [3]
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Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum
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Assessment method [3]
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Participants with first cardiovascular death (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) were recorded by study stratum.
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Timepoint [3]
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Baseline through End of Study (up to 7.5 years)
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Secondary outcome [4]
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Number of Participants With CV/Microvascular Events
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Assessment method [4]
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The number of participants with first cardiovascular or microvascular events (renal, foot, eye) were recorded.
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Timepoint [4]
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Baseline through End of Study (up to 7.5 years)
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Secondary outcome [5]
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Number of Participants With Glycaemic Failure Events
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Assessment method [5]
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Failure of glycaemic control was defined as two consecutive HbA1c values of =8.5 percent, or HbA1c =8.5percent at a single visit, after which the subject was either moved to the post-randomised treatment phase or triple therapy was started.
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Timepoint [5]
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Baseline through to end of randomised dual therapy
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Secondary outcome [6]
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Number of Participants With Addition of Third Oral Agent/Switch to Insulin
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Assessment method [6]
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The number of participants with addition of a third oral agent or switch to insulin from randomised dual combination treatment were recorded.
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Timepoint [6]
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Baseline through End of Study (up to 7.5 years)
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Secondary outcome [7]
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The Number of Participants Starting Insulin at Any Time During the Study
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Assessment method [7]
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The number of participants starting insulin at any time during the study was recorded.
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Timepoint [7]
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Baseline through End of Study (up to 7.5 years)
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Secondary outcome [8]
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Model Adjusted Change From Baseline in HbA1c at Month 60
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Assessment method [8]
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Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in HbA1c was calculated as the value at Month 60 minus the Baseline value.
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Timepoint [8]
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Baseline and Month 60 of randomised dual therapy treatment period
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Secondary outcome [9]
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Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60
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Assessment method [9]
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Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in fasting plasma glucose was calculated as the value at Month 60 minus the Baseline value.
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Timepoint [9]
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Baseline to Month 60 of the randomised dual therapy treatment period
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Secondary outcome [10]
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Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60
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Assessment method [10]
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Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in insulin and pro-insulin was calculated as the value at Month 60 minus the Baseline value.
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Timepoint [10]
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Baseline to Month 60 of the randomised dual therapy treatment period
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Secondary outcome [11]
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Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60
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Assessment method [11]
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Number of responders, i.e., participants meeting glycaemic targets (HbA1c less than or equal to 7 percent, FPG less than or equal to 7 mmol/L)
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Timepoint [11]
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Baseline to Month 60 of the randomised dual therapy treatment period
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Secondary outcome [12]
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Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60
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Assessment method [12]
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The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in HOMA beta-cell function and insulin sensitivity was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
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Timepoint [12]
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Baseline to Month 60 of the randomised dual therapy treatment phase
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Secondary outcome [13]
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Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60
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Assessment method [13]
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The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC, LDL cholesterol, HDL cholesterol, triglycerides, and FFAs was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
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Timepoint [13]
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Baseline to Month 60 of the randomised dual therapy treatment phase
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Secondary outcome [14]
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Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC):High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60
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Assessment method [14]
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The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC:HDL cholesterol and LDL cholesterol:HDL cholesterol was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
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Timepoint [14]
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Baseline to Month 60 of the randomised dual therapy treatment period
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Secondary outcome [15]
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Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60
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Assessment method [15]
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The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in Apo-B was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
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Timepoint [15]
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Baseline to Month 60 of the randomised dual therapy treatment period
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Secondary outcome [16]
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Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60
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Assessment method [16]
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The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in urinary albumin creatinine ratio was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
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Timepoint [16]
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Baseline to Month 60 of the randomised dual therapy treatment phase
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Secondary outcome [17]
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Model Adjusted Change From Baseline in Body Weight at Month 60
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Assessment method [17]
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Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in body weight was calculated as the value at Month 60 minus the Baseline value.
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Timepoint [17]
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Baseline to Month 60 of the randomised dual therapy treatment phase
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Secondary outcome [18]
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Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60
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Assessment method [18]
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Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in alanine aminotransferase was calculated as the value at Month 60 minus the Baseline value.
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Timepoint [18]
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Baseline to Month 60 of the randomised dual therapy treatment phase
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Secondary outcome [19]
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Model Adjusted Change From Baseline in Waist Circumference at Month 60
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Assessment method [19]
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Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in waist circumference was calculated as the value at Month 60 minus the Baseline value.
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Timepoint [19]
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Baseline to Month 60 of the randomised dual therapy treatment phase
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Secondary outcome [20]
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Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60
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Assessment method [20]
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Model adjusted (adjusted for any imbalances in the baseline values between within treatment groups) change from baseline in SBP and DBP was calculated as the value at Month 60 minus the Baseline value.
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Timepoint [20]
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Baseline to Month 60 of the randomised dual therapy treatment phase
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Secondary outcome [21]
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Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60
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Assessment method [21]
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The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in C-Reactive Protein was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
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Timepoint [21]
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Baseline to Month 60 of the randomised dual therapy treatment phase
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Secondary outcome [22]
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Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60
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Assessment method [22]
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The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in fibrinogen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
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Timepoint [22]
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Baseline to Month 60 of the randomised dual therapy treatment phase
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Secondary outcome [23]
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Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60
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Assessment method [23]
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The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in plasminogen activator inhibitor-1 (PAI-1) antigen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).
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Timepoint [23]
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Baseline to Month 60 of the randomised dual therapy treatment phase
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Secondary outcome [24]
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Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Main Study + Observational Follow-up Combined
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Assessment method [24]
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The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
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Timepoint [24]
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From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
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Secondary outcome [25]
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Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up
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Assessment method [25]
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The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
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Timepoint [25]
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From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
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Secondary outcome [26]
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Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined
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Assessment method [26]
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The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
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Timepoint [26]
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0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
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Secondary outcome [27]
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Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up
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Assessment method [27]
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0
The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
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Timepoint [27]
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From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
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Secondary outcome [28]
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Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined
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Assessment method [28]
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0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
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Timepoint [28]
0
0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Query!
Secondary outcome [29]
0
0
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up
Query!
Assessment method [29]
0
0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
Query!
Timepoint [29]
0
0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Query!
Secondary outcome [30]
0
0
Number of Participants With a Bone Fracture Event - Overall and by Gender: Main Study and Observational Follow-up Combined
Query!
Assessment method [30]
0
0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
Query!
Timepoint [30]
0
0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Query!
Secondary outcome [31]
0
0
Number of Participants With a Bone Fracture Event - Overall and by Gender: Observational Follow-up
Query!
Assessment method [31]
0
0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
Query!
Timepoint [31]
0
0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Query!
Secondary outcome [32]
0
0
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined
Query!
Assessment method [32]
0
0
The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
Query!
Timepoint [32]
0
0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Query!
Secondary outcome [33]
0
0
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up
Query!
Assessment method [33]
0
0
The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
Query!
Timepoint [33]
0
0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Query!
Secondary outcome [34]
0
0
Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined
Query!
Assessment method [34]
0
0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
Query!
Timepoint [34]
0
0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Query!
Secondary outcome [35]
0
0
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined
Query!
Assessment method [35]
0
0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
Query!
Timepoint [35]
0
0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Query!
Secondary outcome [36]
0
0
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up
Query!
Assessment method [36]
0
0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
Query!
Timepoint [36]
0
0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Query!
Secondary outcome [37]
0
0
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined
Query!
Assessment method [37]
0
0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).
Query!
Timepoint [37]
0
0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Query!
Secondary outcome [38]
0
0
Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined
Query!
Assessment method [38]
0
0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).
Query!
Timepoint [38]
0
0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Query!
Secondary outcome [39]
0
0
Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined
Query!
Assessment method [39]
0
0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
Query!
Timepoint [39]
0
0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Query!
Secondary outcome [40]
0
0
Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up
Query!
Assessment method [40]
0
0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."
Query!
Timepoint [40]
0
0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Query!
Secondary outcome [41]
0
0
Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined
Query!
Assessment method [41]
0
0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."
Query!
Timepoint [41]
0
0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Query!
Secondary outcome [42]
0
0
Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up
Query!
Assessment method [42]
0
0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."
Query!
Timepoint [42]
0
0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Query!
Secondary outcome [43]
0
0
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up
Query!
Assessment method [43]
0
0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
Query!
Timepoint [43]
0
0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Query!
Eligibility
Key inclusion criteria
- Patients with type II diabetes mellitus as defined by 1999 World Health Organisation
criteria.
- Glycated haemoglobin (HbA1c) >7.0 % to = 9.0 % at visit 1.
- Use of an oral glucose lowering agent for a minimum of 6 months prior to screening and
unchanged for 2 months prior to screening.
- Body mass index >25.0 kg/m2.
Query!
Minimum age
40
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Patients receiving any other glucose lowering therapy which is not metformin or a
sulfonylurea.
- Patients with systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg.
- Patients who have required the use of insulin for glycaemic control at any time in the
past.
- Hospitalisation for any major cardiovascular event in the last 3 months.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/04/2001
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
4447
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Miranda
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Randwick
Query!
Recruitment hospital [3]
0
0
GSK Investigational Site - Wollongong
Query!
Recruitment hospital [4]
0
0
GSK Investigational Site - Carina Heights
Query!
Recruitment hospital [5]
0
0
GSK Investigational Site - Kippa Ring
Query!
Recruitment hospital [6]
0
0
GSK Investigational Site - Sherwood
Query!
Recruitment hospital [7]
0
0
GSK Investigational Site - Keswick
Query!
Recruitment hospital [8]
0
0
GSK Investigational Site - North Adelaide
Query!
Recruitment hospital [9]
0
0
GSK Investigational Site - Port Lincoln
Query!
Recruitment hospital [10]
0
0
GSK Investigational Site - Heidelberg
Query!
Recruitment hospital [11]
0
0
GSK Investigational Site - Malvern
Query!
Recruitment postcode(s) [1]
0
0
2228 - Miranda
Query!
Recruitment postcode(s) [2]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [3]
0
0
2500 - Wollongong
Query!
Recruitment postcode(s) [4]
0
0
4152 - Carina Heights
Query!
Recruitment postcode(s) [5]
0
0
4021 - Kippa Ring
Query!
Recruitment postcode(s) [6]
0
0
4075 - Sherwood
Query!
Recruitment postcode(s) [7]
0
0
5035 - Keswick
Query!
Recruitment postcode(s) [8]
0
0
5006 - North Adelaide
Query!
Recruitment postcode(s) [9]
0
0
5606 - Port Lincoln
Query!
Recruitment postcode(s) [10]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [11]
0
0
3144 - Malvern
Query!
Recruitment outside Australia
Country [1]
0
0
Belgium
Query!
State/province [1]
0
0
Antwerpen
Query!
Country [2]
0
0
Belgium
Query!
State/province [2]
0
0
Arlon
Query!
Country [3]
0
0
Belgium
Query!
State/province [3]
0
0
Brussels
Query!
Country [4]
0
0
Belgium
Query!
State/province [4]
0
0
Edegem
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Genk
Query!
Country [6]
0
0
Belgium
Query!
State/province [6]
0
0
Gent
Query!
Country [7]
0
0
Belgium
Query!
State/province [7]
0
0
Kortrijk
Query!
Country [8]
0
0
Belgium
Query!
State/province [8]
0
0
Liège
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Moerkerke
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Oostham
Query!
Country [11]
0
0
Belgium
Query!
State/province [11]
0
0
Roeselare
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Sint Gillis-Waas
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Vilvoorde
Query!
Country [14]
0
0
Bulgaria
Query!
State/province [14]
0
0
Pleven
Query!
Country [15]
0
0
Bulgaria
Query!
State/province [15]
0
0
Plovdiv
Query!
Country [16]
0
0
Bulgaria
Query!
State/province [16]
0
0
Sofia
Query!
Country [17]
0
0
Bulgaria
Query!
State/province [17]
0
0
Varna
Query!
Country [18]
0
0
Croatia
Query!
State/province [18]
0
0
Krapinske Toplice
Query!
Country [19]
0
0
Croatia
Query!
State/province [19]
0
0
Rijeka
Query!
Country [20]
0
0
Croatia
Query!
State/province [20]
0
0
Slavonski Brod
Query!
Country [21]
0
0
Croatia
Query!
State/province [21]
0
0
Varaždin
Query!
Country [22]
0
0
Croatia
Query!
State/province [22]
0
0
Zagreb
Query!
Country [23]
0
0
Czech Republic
Query!
State/province [23]
0
0
Brno
Query!
Country [24]
0
0
Czech Republic
Query!
State/province [24]
0
0
Ceske Budejovice
Query!
Country [25]
0
0
Czech Republic
Query!
State/province [25]
0
0
Holice V Cechach
Query!
Country [26]
0
0
Czech Republic
Query!
State/province [26]
0
0
Hradec Kralove
Query!
Country [27]
0
0
Czech Republic
Query!
State/province [27]
0
0
Jindrichuv Hradec
Query!
Country [28]
0
0
Czech Republic
Query!
State/province [28]
0
0
Ostrava Poruba
Query!
Country [29]
0
0
Czech Republic
Query!
State/province [29]
0
0
Pisek
Query!
Country [30]
0
0
Czech Republic
Query!
State/province [30]
0
0
Praha 2
Query!
Country [31]
0
0
Czech Republic
Query!
State/province [31]
0
0
Praha 4
Query!
Country [32]
0
0
Czech Republic
Query!
State/province [32]
0
0
Rakovnik
Query!
Country [33]
0
0
Czech Republic
Query!
State/province [33]
0
0
Tabor
Query!
Country [34]
0
0
Czech Republic
Query!
State/province [34]
0
0
Trutnov
Query!
Country [35]
0
0
Denmark
Query!
State/province [35]
0
0
Aalborg
Query!
Country [36]
0
0
Denmark
Query!
State/province [36]
0
0
Aarhus
Query!
Country [37]
0
0
Denmark
Query!
State/province [37]
0
0
Copenhagen
Query!
Country [38]
0
0
Denmark
Query!
State/province [38]
0
0
Glostrup
Query!
Country [39]
0
0
Denmark
Query!
State/province [39]
0
0
Hilleroed
Query!
Country [40]
0
0
Denmark
Query!
State/province [40]
0
0
Koge
Query!
Country [41]
0
0
Denmark
Query!
State/province [41]
0
0
Kolding
Query!
Country [42]
0
0
Denmark
Query!
State/province [42]
0
0
København NV
Query!
Country [43]
0
0
Denmark
Query!
State/province [43]
0
0
Naestved
Query!
Country [44]
0
0
Denmark
Query!
State/province [44]
0
0
Odense C
Query!
Country [45]
0
0
Denmark
Query!
State/province [45]
0
0
Silkeborg
Query!
Country [46]
0
0
Denmark
Query!
State/province [46]
0
0
Slagelse
Query!
Country [47]
0
0
Estonia
Query!
State/province [47]
0
0
Paide
Query!
Country [48]
0
0
Estonia
Query!
State/province [48]
0
0
Parnu
Query!
Country [49]
0
0
Estonia
Query!
State/province [49]
0
0
Rakvere
Query!
Country [50]
0
0
Estonia
Query!
State/province [50]
0
0
Saku
Query!
Country [51]
0
0
Estonia
Query!
State/province [51]
0
0
Tallinn
Query!
Country [52]
0
0
Estonia
Query!
State/province [52]
0
0
Tartu
Query!
Country [53]
0
0
Estonia
Query!
State/province [53]
0
0
Viljandi
Query!
Country [54]
0
0
Finland
Query!
State/province [54]
0
0
Espoo
Query!
Country [55]
0
0
Finland
Query!
State/province [55]
0
0
Hanko
Query!
Country [56]
0
0
Finland
Query!
State/province [56]
0
0
Helsinki
Query!
Country [57]
0
0
Finland
Query!
State/province [57]
0
0
Hyvinkaa
Query!
Country [58]
0
0
Finland
Query!
State/province [58]
0
0
Jyväskylä
Query!
Country [59]
0
0
Finland
Query!
State/province [59]
0
0
Kerava
Query!
Country [60]
0
0
Finland
Query!
State/province [60]
0
0
Kuopio
Query!
Country [61]
0
0
Finland
Query!
State/province [61]
0
0
Lahti
Query!
Country [62]
0
0
Finland
Query!
State/province [62]
0
0
Lappeenranta
Query!
Country [63]
0
0
Finland
Query!
State/province [63]
0
0
Oulun kaupunki
Query!
Country [64]
0
0
Finland
Query!
State/province [64]
0
0
Riihimäki
Query!
Country [65]
0
0
Finland
Query!
State/province [65]
0
0
Rovaniemi
Query!
Country [66]
0
0
Finland
Query!
State/province [66]
0
0
Seinajoki
Query!
Country [67]
0
0
Finland
Query!
State/province [67]
0
0
Tampere
Query!
Country [68]
0
0
Finland
Query!
State/province [68]
0
0
Turku
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Nord-Pas-de-Calais
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Amilly
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Arras
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Aspach le Bas 68700
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Aubagne
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Auchy les Hesdin
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Azille
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Beaumont Le Roger
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Beaumont sur Leze
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Belfort
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Belpech
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Blotzheim
Query!
Country [81]
0
0
France
Query!
State/province [81]
0
0
Bondy
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
BP 1542 Dijon
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Broglie
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Calmont
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Carbonne
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Carcassonne 11000
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Carcassonne
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Cassis
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Castelnaudary
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Catelnaudary
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Cernay
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Champhol
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Chartres
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Colmar
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Corbeil Essonne
Query!
Country [96]
0
0
France
Query!
State/province [96]
0
0
Coursan
Query!
Country [97]
0
0
France
Query!
State/province [97]
0
0
Cuincy
Query!
Country [98]
0
0
France
Query!
State/province [98]
0
0
Danjoutin
Query!
Country [99]
0
0
France
Query!
State/province [99]
0
0
Dessenheim
Query!
Country [100]
0
0
France
Query!
State/province [100]
0
0
Dieppe
Query!
Country [101]
0
0
France
Query!
State/province [101]
0
0
Dunkerque
Query!
Country [102]
0
0
France
Query!
State/province [102]
0
0
Epernon
Query!
Country [103]
0
0
France
Query!
State/province [103]
0
0
Gemenos
Query!
Country [104]
0
0
France
Query!
State/province [104]
0
0
Hanches
Query!
Country [105]
0
0
France
Query!
State/province [105]
0
0
Hautot sur Mer
Query!
Country [106]
0
0
France
Query!
State/province [106]
0
0
Husseren Wesserling
Query!
Country [107]
0
0
France
Query!
State/province [107]
0
0
Kembs
Query!
Country [108]
0
0
France
Query!
State/province [108]
0
0
La Barre En Ouche
Query!
Country [109]
0
0
France
Query!
State/province [109]
0
0
La Verdière
Query!
Country [110]
0
0
France
Query!
State/province [110]
0
0
Labarth-Sur-Leze
Query!
Country [111]
0
0
France
Query!
State/province [111]
0
0
Labarthe-Sur-Leze
Query!
Country [112]
0
0
France
Query!
State/province [112]
0
0
Le Grau Du Roi
Query!
Country [113]
0
0
France
Query!
State/province [113]
0
0
Le Lherm 31600
Query!
Country [114]
0
0
France
Query!
State/province [114]
0
0
Le Perray En Yvelines
Query!
Country [115]
0
0
France
Query!
State/province [115]
0
0
Lezignan-Corbières
Query!
Country [116]
0
0
France
Query!
State/province [116]
0
0
Maintenon
Query!
Country [117]
0
0
France
Query!
State/province [117]
0
0
Marseille
Query!
Country [118]
0
0
France
Query!
State/province [118]
0
0
Masevaux
Query!
Country [119]
0
0
France
Query!
State/province [119]
0
0
Maubeuge
Query!
Country [120]
0
0
France
Query!
State/province [120]
0
0
Monfort sur Risle
Query!
Country [121]
0
0
France
Query!
State/province [121]
0
0
Mulhouse
Query!
Country [122]
0
0
France
Query!
State/province [122]
0
0
Muret
Query!
Country [123]
0
0
France
Query!
State/province [123]
0
0
Nassandres
Query!
Country [124]
0
0
France
Query!
State/province [124]
0
0
Nevers cedex
Query!
Country [125]
0
0
France
Query!
State/province [125]
0
0
Nogent le Phaye
Query!
Country [126]
0
0
France
Query!
State/province [126]
0
0
Orbec
Query!
Country [127]
0
0
France
Query!
State/province [127]
0
0
Paris
Query!
Country [128]
0
0
France
Query!
State/province [128]
0
0
Pierre Benite Cedex
Query!
Country [129]
0
0
France
Query!
State/province [129]
0
0
Pierres
Query!
Country [130]
0
0
France
Query!
State/province [130]
0
0
Pinsaguel
Query!
Country [131]
0
0
France
Query!
State/province [131]
0
0
Roux Mesnil Bouteille
Query!
Country [132]
0
0
France
Query!
State/province [132]
0
0
Rugles
Query!
Country [133]
0
0
France
Query!
State/province [133]
0
0
Saint Leger sur Yvelines
Query!
Country [134]
0
0
France
Query!
State/province [134]
0
0
Saint-Eulalie Badens
Query!
Country [135]
0
0
France
Query!
State/province [135]
0
0
Seysses
Query!
Country [136]
0
0
France
Query!
State/province [136]
0
0
Thann
Query!
Country [137]
0
0
France
Query!
State/province [137]
0
0
Thiberville
Query!
Country [138]
0
0
France
Query!
State/province [138]
0
0
Toulouse
Query!
Country [139]
0
0
France
Query!
State/province [139]
0
0
Trebbes
Query!
Country [140]
0
0
France
Query!
State/province [140]
0
0
Trebes
Query!
Country [141]
0
0
France
Query!
State/province [141]
0
0
Valenciennes
Query!
Country [142]
0
0
France
Query!
State/province [142]
0
0
Vogelsheim
Query!
Country [143]
0
0
France
Query!
State/province [143]
0
0
Voves
Query!
Country [144]
0
0
France
Query!
State/province [144]
0
0
Wittenheim
Query!
Country [145]
0
0
Germany
Query!
State/province [145]
0
0
Baden-Wuerttemberg
Query!
Country [146]
0
0
Germany
Query!
State/province [146]
0
0
Bayern
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Hessen
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Niedersachsen
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Nordrhein-Westfalen
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Rheinland-Pfalz
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Saarland
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Sachsen
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Thueringen
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Hamburg
Query!
Country [155]
0
0
Greece
Query!
State/province [155]
0
0
Athens
Query!
Country [156]
0
0
Greece
Query!
State/province [156]
0
0
Haidari, Athens
Query!
Country [157]
0
0
Greece
Query!
State/province [157]
0
0
Ioannina
Query!
Country [158]
0
0
Greece
Query!
State/province [158]
0
0
Maroussi
Query!
Country [159]
0
0
Greece
Query!
State/province [159]
0
0
Patra
Query!
Country [160]
0
0
Greece
Query!
State/province [160]
0
0
Piraeus-Athens
Query!
Country [161]
0
0
Greece
Query!
State/province [161]
0
0
Thessalonikis
Query!
Country [162]
0
0
Greece
Query!
State/province [162]
0
0
Thessaloniki
Query!
Country [163]
0
0
Hungary
Query!
State/province [163]
0
0
Budapest
Query!
Country [164]
0
0
Hungary
Query!
State/province [164]
0
0
Debrecen
Query!
Country [165]
0
0
Hungary
Query!
State/province [165]
0
0
Eger
Query!
Country [166]
0
0
Hungary
Query!
State/province [166]
0
0
Gyor
Query!
Country [167]
0
0
Hungary
Query!
State/province [167]
0
0
Gyula
Query!
Country [168]
0
0
Hungary
Query!
State/province [168]
0
0
Kurtag99
Query!
Country [169]
0
0
Hungary
Query!
State/province [169]
0
0
Nyiregyháza
Query!
Country [170]
0
0
Hungary
Query!
State/province [170]
0
0
Patkaj98
Query!
Country [171]
0
0
Hungary
Query!
State/province [171]
0
0
Siofok
Query!
Country [172]
0
0
Hungary
Query!
State/province [172]
0
0
Szentes
Query!
Country [173]
0
0
Hungary
Query!
State/province [173]
0
0
Szombathely
Query!
Country [174]
0
0
Hungary
Query!
State/province [174]
0
0
Veszprem
Query!
Country [175]
0
0
Hungary
Query!
State/province [175]
0
0
Zalaegerszeg
Query!
Country [176]
0
0
Italy
Query!
State/province [176]
0
0
Calabria
Query!
Country [177]
0
0
Italy
Query!
State/province [177]
0
0
Campania
Query!
Country [178]
0
0
Italy
Query!
State/province [178]
0
0
Emilia-Romagna
Query!
Country [179]
0
0
Italy
Query!
State/province [179]
0
0
Lazio
Query!
Country [180]
0
0
Italy
Query!
State/province [180]
0
0
Liguria
Query!
Country [181]
0
0
Italy
Query!
State/province [181]
0
0
Lombardia
Query!
Country [182]
0
0
Italy
Query!
State/province [182]
0
0
Molise
Query!
Country [183]
0
0
Italy
Query!
State/province [183]
0
0
Piemonte
Query!
Country [184]
0
0
Italy
Query!
State/province [184]
0
0
Sardegna
Query!
Country [185]
0
0
Italy
Query!
State/province [185]
0
0
Sicilia
Query!
Country [186]
0
0
Italy
Query!
State/province [186]
0
0
Toscana
Query!
Country [187]
0
0
Italy
Query!
State/province [187]
0
0
Bari
Query!
Country [188]
0
0
Italy
Query!
State/province [188]
0
0
Parma
Query!
Country [189]
0
0
Italy
Query!
State/province [189]
0
0
Roma
Query!
Country [190]
0
0
Latvia
Query!
State/province [190]
0
0
Jekabpils
Query!
Country [191]
0
0
Latvia
Query!
State/province [191]
0
0
Lagzdi60
Query!
Country [192]
0
0
Latvia
Query!
State/province [192]
0
0
Limbazi
Query!
Country [193]
0
0
Latvia
Query!
State/province [193]
0
0
Ogre
Query!
Country [194]
0
0
Latvia
Query!
State/province [194]
0
0
Riga
Query!
Country [195]
0
0
Latvia
Query!
State/province [195]
0
0
Sturii59
Query!
Country [196]
0
0
Latvia
Query!
State/province [196]
0
0
Tukums
Query!
Country [197]
0
0
Lithuania
Query!
State/province [197]
0
0
Kaunas
Query!
Country [198]
0
0
Lithuania
Query!
State/province [198]
0
0
Klaipeda
Query!
Country [199]
0
0
Lithuania
Query!
State/province [199]
0
0
Vilnius
Query!
Country [200]
0
0
Netherlands
Query!
State/province [200]
0
0
Geleen
Query!
Country [201]
0
0
Netherlands
Query!
State/province [201]
0
0
Groningen
Query!
Country [202]
0
0
Netherlands
Query!
State/province [202]
0
0
Hengelo
Query!
Country [203]
0
0
Netherlands
Query!
State/province [203]
0
0
Hoogvliet
Query!
Country [204]
0
0
Netherlands
Query!
State/province [204]
0
0
Kerkrade
Query!
Country [205]
0
0
Netherlands
Query!
State/province [205]
0
0
Landgraaf
Query!
Country [206]
0
0
Netherlands
Query!
State/province [206]
0
0
Musselkanaal
Query!
Country [207]
0
0
Netherlands
Query!
State/province [207]
0
0
Nijmegen
Query!
Country [208]
0
0
Netherlands
Query!
State/province [208]
0
0
Oude Pekela
Query!
Country [209]
0
0
Netherlands
Query!
State/province [209]
0
0
Ridderkerk
Query!
Country [210]
0
0
Netherlands
Query!
State/province [210]
0
0
Rijswijk
Query!
Country [211]
0
0
Netherlands
Query!
State/province [211]
0
0
Roosendaal
Query!
Country [212]
0
0
Netherlands
Query!
State/province [212]
0
0
Rotterdam
Query!
Country [213]
0
0
Netherlands
Query!
State/province [213]
0
0
St. Willebrord
Query!
Country [214]
0
0
Netherlands
Query!
State/province [214]
0
0
Zoetermeer
Query!
Country [215]
0
0
Netherlands
Query!
State/province [215]
0
0
Zwijndrecht
Query!
Country [216]
0
0
New Zealand
Query!
State/province [216]
0
0
Christchurch
Query!
Country [217]
0
0
New Zealand
Query!
State/province [217]
0
0
Dunedin
Query!
Country [218]
0
0
New Zealand
Query!
State/province [218]
0
0
Hastings
Query!
Country [219]
0
0
New Zealand
Query!
State/province [219]
0
0
Otahuhu, Auckland
Query!
Country [220]
0
0
New Zealand
Query!
State/province [220]
0
0
Palmerston North
Query!
Country [221]
0
0
New Zealand
Query!
State/province [221]
0
0
Takapuna, Auckland
Query!
Country [222]
0
0
New Zealand
Query!
State/province [222]
0
0
Tauranga
Query!
Country [223]
0
0
New Zealand
Query!
State/province [223]
0
0
Wellington
Query!
Country [224]
0
0
Poland
Query!
State/province [224]
0
0
Bialystok
Query!
Country [225]
0
0
Poland
Query!
State/province [225]
0
0
Bydgoszcz
Query!
Country [226]
0
0
Poland
Query!
State/province [226]
0
0
Gdansk
Query!
Country [227]
0
0
Poland
Query!
State/province [227]
0
0
Grudziadz
Query!
Country [228]
0
0
Poland
Query!
State/province [228]
0
0
Krakow
Query!
Country [229]
0
0
Poland
Query!
State/province [229]
0
0
Lodz
Query!
Country [230]
0
0
Poland
Query!
State/province [230]
0
0
Lublin
Query!
Country [231]
0
0
Poland
Query!
State/province [231]
0
0
Olsztyn
Query!
Country [232]
0
0
Poland
Query!
State/province [232]
0
0
Poznan
Query!
Country [233]
0
0
Poland
Query!
State/province [233]
0
0
Warszawa
Query!
Country [234]
0
0
Poland
Query!
State/province [234]
0
0
Wroclaw
Query!
Country [235]
0
0
Romania
Query!
State/province [235]
0
0
Bucharest
Query!
Country [236]
0
0
Romania
Query!
State/province [236]
0
0
Bucuresti
Query!
Country [237]
0
0
Romania
Query!
State/province [237]
0
0
Cluj-Napoca
Query!
Country [238]
0
0
Romania
Query!
State/province [238]
0
0
Craiova
Query!
Country [239]
0
0
Romania
Query!
State/province [239]
0
0
Iasi
Query!
Country [240]
0
0
Romania
Query!
State/province [240]
0
0
Timisoara
Query!
Country [241]
0
0
Russian Federation
Query!
State/province [241]
0
0
Moscow
Query!
Country [242]
0
0
Russian Federation
Query!
State/province [242]
0
0
St Petersburg
Query!
Country [243]
0
0
Russian Federation
Query!
State/province [243]
0
0
St-Petersburg
Query!
Country [244]
0
0
Slovakia
Query!
State/province [244]
0
0
Banska Bystrica
Query!
Country [245]
0
0
Slovakia
Query!
State/province [245]
0
0
Bratislava
Query!
Country [246]
0
0
Slovakia
Query!
State/province [246]
0
0
Kosice
Query!
Country [247]
0
0
Slovakia
Query!
State/province [247]
0
0
Kysucke Nove Mesto
Query!
Country [248]
0
0
Slovakia
Query!
State/province [248]
0
0
Lubochna
Query!
Country [249]
0
0
Slovakia
Query!
State/province [249]
0
0
Lucenec
Query!
Country [250]
0
0
Slovakia
Query!
State/province [250]
0
0
Presov
Query!
Country [251]
0
0
Slovakia
Query!
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Prievidza
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Slovakia
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Sahy
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Slovakia
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Samorin
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Slovakia
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Trencin
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Slovakia
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Zilina
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Benidorm
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Spain
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Bilbao
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Spain
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Caceres
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Spain
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Cadiz
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Spain
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Granada
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Spain
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Madrid
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Spain
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Palma de Mallorca
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Spain
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Reus
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Spain
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Santander
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Spain
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Vazquc56
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Spain
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Vizcaya
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Sweden
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Eksjö
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Sweden
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Göteborg
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Sweden
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Helsingborg
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Sweden
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Kristianstad
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Sweden
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State/province [273]
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Kungälv
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Sweden
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Köping
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Sweden
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State/province [275]
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Linköpiing
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Sweden
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Linköping
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Sweden
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Lund
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Sweden
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Mora
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Sweden
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Nacka
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Sweden
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Norrköping
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Country [281]
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Sweden
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Oskarshamn
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Sweden
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Skene
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Country [283]
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Sweden
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Stockholm
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Sweden
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Uddevalla
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Sweden
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Umeå
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Sweden
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Uppsala
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Sweden
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Vadstena
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Ukraine
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Dnepropetrovsk
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Ukraine
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Kharkiv
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Ukraine
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Kiev
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Ukraine
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Kyiv
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Ukraine
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Lvov
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Country [293]
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Ukraine
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Vinnitsa
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United Kingdom
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Cambridgeshire
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United Kingdom
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Cornwall
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United Kingdom
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Derbyshire
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Country [297]
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United Kingdom
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Lanarkshire
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United Kingdom
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Leicestershire
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United Kingdom
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Northamptonshire
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United Kingdom
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Renfrewshire
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United Kingdom
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Somerset
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United Kingdom
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Warwickshire
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United Kingdom
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Wiltshire
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United Kingdom
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Airdrie
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United Kingdom
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Ashford
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United Kingdom
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Bath
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United Kingdom
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Chesterfield
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United Kingdom
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Chippenham
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United Kingdom
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Coatbridge
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United Kingdom
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Colney
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United Kingdom
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Cumbernauld
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United Kingdom
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Dronfield
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United Kingdom
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Dumbarton
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United Kingdom
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East Kilbride
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United Kingdom
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Falmouth
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United Kingdom
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Garston, Watford
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United Kingdom
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Gateshead
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Glasgow
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United Kingdom
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Hamilton
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United Kingdom
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Harrow
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Kirkintilloch
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Leigh on Sea
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Motherwell
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Newcastle upon Tyne
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Newport
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Nottingham
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United Kingdom
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Old Whittington, Chesterfield
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United Kingdom
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Paisley
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United Kingdom
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Penzance
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United Kingdom
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Rubery, Birmingham
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Sheffield
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Thornhill, Cardiff
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Thornhill
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Uddingston
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Weston Super Mare
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Wishaw
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Woking
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United Kingdom
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Worle, Weston-Super-Mare
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Ethics approval
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Summary
Brief summary
This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week
run-in period will be followed by a median of 6 years of treatment with study medication in
addition to continuation of background glucose lowering therapy. Patients inadequately
controlled on background metformin will be randomised to receive, in addition to metformin,
either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio
of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in
addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of
patients receiving background metformin and SU at entry will be entered into the study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00379769
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Trial related presentations / publications
Home PD, Jones NP, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Komajda M, Curtis P; RECORD Study Group. Rosiglitazone RECORD study: glucose control outcomes at 18 months. Diabet Med. 2007 Jun;24(6):626-34. doi: 10.1111/j.1464-5491.2007.02160.x.
Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Dargie H, Komajda M, Gubb J, Biswas N, Jones NP. Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD): study design and protocol. Diabetologia. 2005 Sep;48(9):1726-35. doi: 10.1007/s00125-005-1869-1. Epub 2005 Jul 16.
Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ; RECORD Study Group. Rosiglitazone evaluated for cardiovascular outcomes--an interim analysis. N Engl J Med. 2007 Jul 5;357(1):28-38. doi: 10.1056/NEJMoa073394. Epub 2007 Jun 5.
Home PD, Pocock SJ, Beck-Nielsen H, Curtis PS, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ; RECORD Study Team. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet. 2009 Jun 20;373(9681):2125-35. doi: 10.1016/S0140-6736(09)60953-3. Epub 2009 Jun 6.
Komajda M, Curtis P, Hanefeld M, Beck-Nielsen H, Pocock SJ, Zambanini A, Jones NP, Gomis R, Home PD; RECORD Study Group. Effect of the addition of rosiglitazone to metformin or sulfonylureas versus metformin/sulfonylurea combination therapy on ambulatory blood pressure in people with type 2 diabetes: a randomized controlled trial (the RECORD study). Cardiovasc Diabetol. 2008 Apr 24;7:10. doi: 10.1186/1475-2840-7-10.
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00379769
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