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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01243424
Registration number
NCT01243424
Ethics application status
Date submitted
17/11/2010
Date registered
18/11/2010
Date last updated
7/01/2020
Titles & IDs
Public title
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes
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Scientific title
A Multicentre, International, Randomised, Parallel Group, Double Blind Study to Evaluate Cardiovascular Safety of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk.
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Secondary ID [1]
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2009-013157-15
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Secondary ID [2]
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1218.74
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Universal Trial Number (UTN)
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Trial acronym
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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 - linagliptin
Treatment: Drugs - glimepiride
Treatment: Drugs - linagliptin placebo
Treatment: Drugs - glimepiride placebo
Experimental: linagliptin - patient to receive linagliptin or glimepiride placebo over encapsulated tablet Quaque die (QD)
Active comparator: glimepiride 1-4 mg QD - patient to receive glimepiride 1-4 mg or linagliptin placebo tablet Quaque die (QD)
Treatment: Drugs: linagliptin
linagliptin tablets 5mg QD
Treatment: Drugs: glimepiride
glimepiride over-encapsulated tablet 1-4 mg QD
Treatment: Drugs: linagliptin placebo
linagliptin placebo
Treatment: Drugs: glimepiride placebo
glimepiride placebo
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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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The First 3-point Major Adverse Cardiovascular Events (3P-MACE)
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Assessment method [1]
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The first occurrence of any of the following Clinical Event Committee (CEC) confirmed adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), or nonfatal stroke is presented.
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Timepoint [1]
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From randomization until individual day of trial completion, up to 432 weeks
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Secondary outcome [1]
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The First 4-point (4P)- MACE
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Assessment method [1]
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The first key secondary endpoint was time to first occurrence of any of the following adjudicated components of the composite endpoint: CV death (including fatal stroke and fatal MI), non-fatal stroke, non-fatal MI (excluding silent MI), or hospitalisation for unstable angina pectoris.
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Timepoint [1]
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From randomization until individual day of trial completion, up to 432 weeks
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Secondary outcome [2]
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Percentage of Participants Taking Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c =7.0%) Without Need for Rescue Medication, Without >2% Weight Gain, and Without Moderate/Severe Hypoglycaemic Episodes During Maintenance Phase
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Assessment method [2]
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The second key secondary endpoint was a composite endpoint of treatment sustainability, defined as the percentage of patients taking trial medication at trial end, maintained glycaemic control (HbA1c =7.0%) without need for rescue medication, without \>2% weight gain, and without moderate/severe hypoglycaemic episodes during maintenance phase.
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Timepoint [2]
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From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase)
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Secondary outcome [3]
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Percentage of Participants Who Were on Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c =7.0%) Without Need for Rescue Medication, and Without >2% Weight Gain During Maintenance Phase
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Assessment method [3]
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The third key secondary endpoint was a composite endpoint of treatment sustainability, defined as percentage of patients who were on trial medication at trial end, maintained glycaemic control (HbA1c =7.0%) without need for rescue medication, and without \>2% weight gain during maintenance phase.
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Timepoint [3]
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From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase)
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Secondary outcome [4]
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Percentage of Participants With the Occurrence of at Least One Event of 3P-MACE
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Assessment method [4]
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Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI) and non-fatal stroke is presented as secondary CV endpoint.
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Timepoint [4]
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From randomization until individual day of trial completion, up to 432 weeks
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Secondary outcome [5]
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Percentage of Participants With the Occurrence of at Least One Event of 4P -MACE
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Assessment method [5]
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Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI), non-fatal stroke, and hospitalisation for unstable angina pectoris is presented as secondary CV endpoint.
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Timepoint [5]
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From randomization until individual day of trial completion, up to 432 weeks
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Secondary outcome [6]
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Percentage of Participants With Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events
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Assessment method [6]
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Percentage of participants with occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of:
* CV death (including fatal stroke and fatal MI)
* non-fatal MI
* non-fatal stroke
* hospitalisation for unstable angina pectoris
* TIA
* hospitalisation for heart failure
* hospitalisation for coronary revascularisation procedures (CABG, PCI)
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Timepoint [6]
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From start of the treatment until 7 days after the end of treatment, up to 433 weeks
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Secondary outcome [7]
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Time to First Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events
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Assessment method [7]
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Time to first occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of:
* CV death (including fatal stroke and fatal MI)
* non-fatal MI
* non-fatal stroke
* hospitalisation for unstable angina pectoris
* Transient ischaemic attack (TIA)
* hospitalisation for heart failure
* hospitalisation for coronary revascularisation procedures (CABG, PCI)
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Timepoint [7]
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From start of the treatment until 7 days after the end of treatment, up to 433 weeks
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Secondary outcome [8]
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Change From Baseline to Final Visit in Hemoglobin A1c (HbA1c)
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Assessment method [8]
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Change from baseline to final visit in HbA1c is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
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Timepoint [8]
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Baseline and week 432
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Secondary outcome [9]
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Change From Baseline to Final Visit in Fasting Plasma Glucose (FPG)
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Assessment method [9]
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Change from baseline to final visit in fasting plasma glucose (FPG) is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
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Timepoint [9]
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Baseline and week 432
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Secondary outcome [10]
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Change From Baseline to Final Visit Fasting Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol and High-density Lipoprotein (HDL) Cholesterol
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Assessment method [10]
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Change from baseline to final visit in total cholesterol, low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
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Timepoint [10]
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Baseline and week 432
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Secondary outcome [11]
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Change From Baseline to Final Visit in Triglycerides
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Assessment method [11]
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Change from baseline to final visit in triglycerides is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
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Timepoint [11]
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Baseline and week 432
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Secondary outcome [12]
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Change From Baseline to Final Visit in Creatinine
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Assessment method [12]
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Change from baseline to final visit in creatinine is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
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Timepoint [12]
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Baseline and week 432
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Secondary outcome [13]
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Change From Baseline to Final Visit in Estimated Glomerular Filtration Rate (eGFR)
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Assessment method [13]
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Change from baseline to final visit in eGFR is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
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Timepoint [13]
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Baseline and week 432
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Secondary outcome [14]
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Change From Baseline to Final Visit in Urine Albumin Creatinine Ratio (UACR)
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Assessment method [14]
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Change from baseline to final visit in UACR is presented as secondary diabetes-related endpoint. Least square mean is adjusted geometric mean (gMean) ratio. The Final Visit value referred to the last value obtained on-treatment.
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Timepoint [14]
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Baseline and week 432
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Secondary outcome [15]
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Percentage of Participants With Transition in Albuminuria Classes
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Assessment method [15]
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Percentage of patients with transition in albuminuria classes is presented as secondary endpoint. Data for last value on treatment (LVOT) to baseline (base) is presented.
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Timepoint [15]
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Baseline and week 432
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Secondary outcome [16]
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Change From Baseline of Insulin Secretion Rate (ISR) at Fixed Glucose Concentration at 208 Weeks
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Assessment method [16]
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The endpoint change from baseline of ISR at fixed glucose concentration at 208 weeks as derived from a 3-hour meal tolerance test is Beta-cell function sub-study endpoint.
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Timepoint [16]
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Baseline and week 208
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Secondary outcome [17]
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Percentage of Participants With Occurrence of Accelerated Cognitive Decline at End of Follow-up
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Assessment method [17]
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Occurrence of accelerated cognitive decline based on regression based index (RBI) score at end of follow-up (a dichotomous outcome measure; presence or absence of accelerated cognitive decline) is Cognition sub-study endpoint.
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Timepoint [17]
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433 weeks
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Secondary outcome [18]
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Continuous Glucose Monitoring (CGM) Sub-study: Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Milligrams/ Deciliter) to End of Study
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Assessment method [18]
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Baseline data for the continuous glucose monitoring sub-study was collected and analyzed. However, the participant number was far less than original planned. The study was stopped early around week 64 (V9) due to recruitment issues and data were not pre-specified to be analyzed and reported at week 64 time point as target was with an estimated time point of 432 weeks for primary or secondary end points. Thus this endpoint was not analysed and only the baseline data collected were analysed and the results are reported in this CGM substudy endpoint.
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Timepoint [18]
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Baseline
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Secondary outcome [19]
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CGM Sub-study : Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Millimoles/ Litre) to End of Study
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Assessment method [19]
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Baseline data for the continuous glucose monitoring sub-study was collected and analyzed. However, the participant number was far less than original planned. The study was stopped early around week 64 (V9) due to recruitment issues and data were not pre-specified to be analyzed and reported at week 64 time point as target was with an estimated time point of 432 weeks for primary or secondary end points. Thus this endpoint was not analysed and only the baseline data collected were analysed and the results are reported in this CGM substudy endpoint.
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Timepoint [19]
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Baseline
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Eligibility
Key inclusion criteria
Inclusion criteria:
1. Type 2 diabetes
2. Elevated glycosylated haemoglobin (HbA1c): 6.5 - 8.5%, inclusive, if treatment naïve or mono-/dual therapy with metformin and/or an alpha-glucosidase inhibitor; 6.5 - 7.5%, inclusive, if treatment with sulphonylurea/glinide in mono- or dual (with metformin OR an alpha-glucosidase inhibitor) therapy)
3. Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor
4. BMI =< 45kg/m²
5. age between >= 40 and =< 85 years
6. signed and dated written International Conference of Harmonisation( ICF)
7. stable anti-diabetic background for at least 8 wks before study start
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Minimum age
40
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
1. Type 1 diabetes
2. Treatment with other antidiabetic drugs (e.g. rosiglitazone, pioglitazone, Glucagon-like peptide 1 (GLP-1) analogue/agonists, Dipeptidyl-peptidase IV (DPP-IV) inhibitors or any insulin) prior to informed consent (previous short term use of insulin (up to two weeks) is allowed if taken at least 8 weeks prior informed consent)
3. treatment with any anti-obesity drug less than 3 months before ICF
4. uncontrolled hyperglycemia
5. previous or planned bariatric surgery or intervention
6. current or planned system corticoid treatment
7. change in thyroid hormones treatment
8. acute liver disease or impaired hepatic function
9. pre-planned coronary artery revascularization within 6 months of ICF
10. known hypersensitivity to any of the components
11. Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information
12. congestive heart failure class III or IV
13. acute or chronic metabolic acidosis
14. hereditary galactose intolerance
15. alcohol or drug abuse
16. participation in another trail with IMP given 2 months before Investigational Medicinal/Medical Product (IMP) start
17. pre-menopausal women who are nursing or pregnant or of child-bearing potential and not willing to use acceptable method of birth control
18. patients considered reliable by the investigator
19. acute coronary syndrome =< 6 wks before ICF
20. stroke or Transient Ischemic Attack (TIA) =< 3 months prior to ICF
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/11/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/08/2018
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Sample size
Target
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Accrual to date
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Final
6103
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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Royal Brisbane & Women's Hospital-Endocrinology - Herston
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Recruitment hospital [2]
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Logan Hospital - Meadowbrook
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Recruitment hospital [3]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [4]
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Eastern Clinical Research Unit - East Ringwood
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Recruitment hospital [5]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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4029 - Herston
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Recruitment postcode(s) [2]
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4131 - Meadowbrook
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3135 - East Ringwood
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Recruitment postcode(s) [5]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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Alabama
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Alaska
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Arizona
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Arkansas
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California
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Colorado
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Kentucky
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Mississippi
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Missouri
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Nebraska
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Pennsylvania
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Virginia
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Washington
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Argentina
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Bahía Blanca
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Argentina
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Caba
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Argentina
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Capital Federal
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Argentina
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Cordoba
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Argentina
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Corrientes
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Argentina
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Córdoba
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Argentina
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La Plata
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Argentina
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Mendoza
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Argentina
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Rosario
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Argentina
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Salta
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Argentina
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San Miguel de Tucumán
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Argentina
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Santa Fe
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Belgium
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Blankenberge
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Bonheiden
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Belgium
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Belgium
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Belgium
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Belgium
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Gozée
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Belgium
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Hasselt
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Belgium
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Herent
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Belgium
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Linkebeek
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Belgium
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Moorsel
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Belgium
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Natoye
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Belgium
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Tremelo
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Brazil
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Belém
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Brazil
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Curitiba
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Brazil
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Goiânia
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Brazil
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Higienópolis
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Brazil
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Joaquim Távora
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Brazil
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Porto Alegre
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Brazil
Query!
State/province [68]
0
0
Río de Janeiro
Query!
Country [69]
0
0
Brazil
Query!
State/province [69]
0
0
Santa Cecília
Query!
Country [70]
0
0
Brazil
Query!
State/province [70]
0
0
São José do Rio Preto
Query!
Country [71]
0
0
Brazil
Query!
State/province [71]
0
0
São Paulo
Query!
Country [72]
0
0
Brazil
Query!
State/province [72]
0
0
Vila Clementino
Query!
Country [73]
0
0
Bulgaria
Query!
State/province [73]
0
0
Pleven
Query!
Country [74]
0
0
Bulgaria
Query!
State/province [74]
0
0
Sofia
Query!
Country [75]
0
0
Bulgaria
Query!
State/province [75]
0
0
Stara Zagora
Query!
Country [76]
0
0
Canada
Query!
State/province [76]
0
0
Migration Data
Query!
Country [77]
0
0
Canada
Query!
State/province [77]
0
0
Newfoundland and Labrador
Query!
Country [78]
0
0
Canada
Query!
State/province [78]
0
0
Ontario
Query!
Country [79]
0
0
Canada
Query!
State/province [79]
0
0
Prince Edward Island
Query!
Country [80]
0
0
Canada
Query!
State/province [80]
0
0
Quebec
Query!
Country [81]
0
0
Chile
Query!
State/province [81]
0
0
Providencia
Query!
Country [82]
0
0
Chile
Query!
State/province [82]
0
0
Temuco
Query!
Country [83]
0
0
Chile
Query!
State/province [83]
0
0
Viña del Mar
Query!
Country [84]
0
0
Colombia
Query!
State/province [84]
0
0
Barranquilla
Query!
Country [85]
0
0
Colombia
Query!
State/province [85]
0
0
Bogota
Query!
Country [86]
0
0
Colombia
Query!
State/province [86]
0
0
Bogotá
Query!
Country [87]
0
0
Colombia
Query!
State/province [87]
0
0
Cartagena
Query!
Country [88]
0
0
Colombia
Query!
State/province [88]
0
0
El Bosque
Query!
Country [89]
0
0
Colombia
Query!
State/province [89]
0
0
Tolima
Query!
Country [90]
0
0
Czechia
Query!
State/province [90]
0
0
Jablonec nad Nisou
Query!
Country [91]
0
0
Czechia
Query!
State/province [91]
0
0
Olomouc-Lazce
Query!
Country [92]
0
0
Czechia
Query!
State/province [92]
0
0
Ostrava
Query!
Country [93]
0
0
Czechia
Query!
State/province [93]
0
0
Plzen
Query!
Country [94]
0
0
Czechia
Query!
State/province [94]
0
0
Praha 8
Query!
Country [95]
0
0
Czechia
Query!
State/province [95]
0
0
Praha
Query!
Country [96]
0
0
Czechia
Query!
State/province [96]
0
0
Prostejov
Query!
Country [97]
0
0
Czechia
Query!
State/province [97]
0
0
Strakonice
Query!
Country [98]
0
0
Finland
Query!
State/province [98]
0
0
Helsinki
Query!
Country [99]
0
0
Finland
Query!
State/province [99]
0
0
Joensuu
Query!
Country [100]
0
0
Finland
Query!
State/province [100]
0
0
Kerava
Query!
Country [101]
0
0
Finland
Query!
State/province [101]
0
0
Kokkola
Query!
Country [102]
0
0
Finland
Query!
State/province [102]
0
0
Kuopio
Query!
Country [103]
0
0
Finland
Query!
State/province [103]
0
0
Oulu
Query!
Country [104]
0
0
Finland
Query!
State/province [104]
0
0
Turku
Query!
Country [105]
0
0
France
Query!
State/province [105]
0
0
Behren Les Forbach
Query!
Country [106]
0
0
France
Query!
State/province [106]
0
0
Bordeaux
Query!
Country [107]
0
0
France
Query!
State/province [107]
0
0
Bourg des Comptes
Query!
Country [108]
0
0
France
Query!
State/province [108]
0
0
Broglie
Query!
Country [109]
0
0
France
Query!
State/province [109]
0
0
Béziers
Query!
Country [110]
0
0
France
Query!
State/province [110]
0
0
Cannes
Query!
Country [111]
0
0
France
Query!
State/province [111]
0
0
Carbonne
Query!
Country [112]
0
0
France
Query!
State/province [112]
0
0
Castets
Query!
Country [113]
0
0
France
Query!
State/province [113]
0
0
Chartres
Query!
Country [114]
0
0
France
Query!
State/province [114]
0
0
Cournonterral
Query!
Country [115]
0
0
France
Query!
State/province [115]
0
0
Fort De France
Query!
Country [116]
0
0
France
Query!
State/province [116]
0
0
Hinx
Query!
Country [117]
0
0
France
Query!
State/province [117]
0
0
La Reunion
Query!
Country [118]
0
0
France
Query!
State/province [118]
0
0
Labarthe sur Leze
Query!
Country [119]
0
0
France
Query!
State/province [119]
0
0
Louvigne De Bie
Query!
Country [120]
0
0
France
Query!
State/province [120]
0
0
Maintenon
Query!
Country [121]
0
0
France
Query!
State/province [121]
0
0
Orthez
Query!
Country [122]
0
0
France
Query!
State/province [122]
0
0
Palau Del Vidre
Query!
Country [123]
0
0
France
Query!
State/province [123]
0
0
Saint Genies Des Fontaines
Query!
Country [124]
0
0
France
Query!
State/province [124]
0
0
St Dié des Vosges Cedex
Query!
Country [125]
0
0
France
Query!
State/province [125]
0
0
Thouars
Query!
Country [126]
0
0
France
Query!
State/province [126]
0
0
Tilly sur Seulles
Query!
Country [127]
0
0
Georgia
Query!
State/province [127]
0
0
Batumi
Query!
Country [128]
0
0
Georgia
Query!
State/province [128]
0
0
Gori
Query!
Country [129]
0
0
Georgia
Query!
State/province [129]
0
0
Kutaisi
Query!
Country [130]
0
0
Georgia
Query!
State/province [130]
0
0
Tbilisi
Query!
Country [131]
0
0
Georgia
Query!
State/province [131]
0
0
Zugdidi
Query!
Country [132]
0
0
Germany
Query!
State/province [132]
0
0
Aachen
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Aschaffenburg
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Asslar
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Bad Nauheim
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Berlin
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Dormagen- Hackenbroich
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
Dortmund
Query!
Country [139]
0
0
Germany
Query!
State/province [139]
0
0
Dresden
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Eisenach
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Elsterwerda
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
Essen
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Flörsheim
Query!
Country [144]
0
0
Germany
Query!
State/province [144]
0
0
Frankfurt
Query!
Country [145]
0
0
Germany
Query!
State/province [145]
0
0
Furth im Wald
Query!
Country [146]
0
0
Germany
Query!
State/province [146]
0
0
Gebhardshain
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Haag
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Hamburg
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Kirchhatten
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Köln
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Künzing
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Leipzig
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Lübeck
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Mainz
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Münster
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Neumünster
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Rehburg-Loccum
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Rodgau/Dudenhofen
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Saarbrücken
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Saint Ingbert / Oberwürzbach
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Schwabenheim
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Stadtbergen
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Wangen
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Zwenkau
Query!
Country [165]
0
0
Greece
Query!
State/province [165]
0
0
Athens
Query!
Country [166]
0
0
Greece
Query!
State/province [166]
0
0
Haidari, Athens
Query!
Country [167]
0
0
Greece
Query!
State/province [167]
0
0
Ioannina
Query!
Country [168]
0
0
Greece
Query!
State/province [168]
0
0
Melissia, Athens
Query!
Country [169]
0
0
Greece
Query!
State/province [169]
0
0
Nikaia
Query!
Country [170]
0
0
Greece
Query!
State/province [170]
0
0
Thessaloniki
Query!
Country [171]
0
0
Hong Kong
Query!
State/province [171]
0
0
Hong Kong
Query!
Country [172]
0
0
Hungary
Query!
State/province [172]
0
0
Ajka
Query!
Country [173]
0
0
Hungary
Query!
State/province [173]
0
0
Baja
Query!
Country [174]
0
0
Hungary
Query!
State/province [174]
0
0
Budapest
Query!
Country [175]
0
0
Hungary
Query!
State/province [175]
0
0
Gyula
Query!
Country [176]
0
0
Hungary
Query!
State/province [176]
0
0
Hódmezövásárhely
Query!
Country [177]
0
0
Hungary
Query!
State/province [177]
0
0
Mako
Query!
Country [178]
0
0
Hungary
Query!
State/province [178]
0
0
Mosonmagyarovar
Query!
Country [179]
0
0
Hungary
Query!
State/province [179]
0
0
Papa
Query!
Country [180]
0
0
Hungary
Query!
State/province [180]
0
0
Szekszard
Query!
Country [181]
0
0
India
Query!
State/province [181]
0
0
Ahmedabad
Query!
Country [182]
0
0
India
Query!
State/province [182]
0
0
Aurangabad
Query!
Country [183]
0
0
India
Query!
State/province [183]
0
0
Bangalore, Karnataka
Query!
Country [184]
0
0
India
Query!
State/province [184]
0
0
Bangalore
Query!
Country [185]
0
0
India
Query!
State/province [185]
0
0
Belgaum
Query!
Country [186]
0
0
India
Query!
State/province [186]
0
0
Chennai
Query!
Country [187]
0
0
India
Query!
State/province [187]
0
0
Coimbatore
Query!
Country [188]
0
0
India
Query!
State/province [188]
0
0
Indore
Query!
Country [189]
0
0
India
Query!
State/province [189]
0
0
Jaipur
Query!
Country [190]
0
0
India
Query!
State/province [190]
0
0
Maharashtra
Query!
Country [191]
0
0
India
Query!
State/province [191]
0
0
Mumbai, Maharastra
Query!
Country [192]
0
0
India
Query!
State/province [192]
0
0
Mumbai
Query!
Country [193]
0
0
India
Query!
State/province [193]
0
0
Nagpur
Query!
Country [194]
0
0
India
Query!
State/province [194]
0
0
Pune
Query!
Country [195]
0
0
India
Query!
State/province [195]
0
0
Thiruvananthapuram
Query!
Country [196]
0
0
India
Query!
State/province [196]
0
0
Vijayawada
Query!
Country [197]
0
0
Ireland
Query!
State/province [197]
0
0
Co. Cork
Query!
Country [198]
0
0
Ireland
Query!
State/province [198]
0
0
Dublin
Query!
Country [199]
0
0
Ireland
Query!
State/province [199]
0
0
Gorey
Query!
Country [200]
0
0
Ireland
Query!
State/province [200]
0
0
Wexford
Query!
Country [201]
0
0
Israel
Query!
State/province [201]
0
0
Ashkelon
Query!
Country [202]
0
0
Israel
Query!
State/province [202]
0
0
Haifa
Query!
Country [203]
0
0
Israel
Query!
State/province [203]
0
0
Holon
Query!
Country [204]
0
0
Israel
Query!
State/province [204]
0
0
Jerusalem
Query!
Country [205]
0
0
Israel
Query!
State/province [205]
0
0
Nahariya
Query!
Country [206]
0
0
Israel
Query!
State/province [206]
0
0
Tel Hashomer
Query!
Country [207]
0
0
Israel
Query!
State/province [207]
0
0
Tel-Aviv
Query!
Country [208]
0
0
Italy
Query!
State/province [208]
0
0
Cagliari
Query!
Country [209]
0
0
Italy
Query!
State/province [209]
0
0
Catanzaro
Query!
Country [210]
0
0
Italy
Query!
State/province [210]
0
0
Genova
Query!
Country [211]
0
0
Italy
Query!
State/province [211]
0
0
Guastalla (RE)
Query!
Country [212]
0
0
Italy
Query!
State/province [212]
0
0
Messina
Query!
Country [213]
0
0
Italy
Query!
State/province [213]
0
0
Milano
Query!
Country [214]
0
0
Italy
Query!
State/province [214]
0
0
Roma
Query!
Country [215]
0
0
Italy
Query!
State/province [215]
0
0
Sesto San Giovanni (MI)
Query!
Country [216]
0
0
Japan
Query!
State/province [216]
0
0
Aichi, Nagoya
Query!
Country [217]
0
0
Japan
Query!
State/province [217]
0
0
Chiba, Matsudo
Query!
Country [218]
0
0
Japan
Query!
State/province [218]
0
0
Fukushima, Date
Query!
Country [219]
0
0
Japan
Query!
State/province [219]
0
0
Fukushima, Nihonmatsu
Query!
Country [220]
0
0
Japan
Query!
State/province [220]
0
0
Fukushima, Sukagawa
Query!
Country [221]
0
0
Japan
Query!
State/province [221]
0
0
Hyogo, Amagasaki
Query!
Country [222]
0
0
Japan
Query!
State/province [222]
0
0
Hyogo, Takasago
Query!
Country [223]
0
0
Japan
Query!
State/province [223]
0
0
Kanagawa, Yokohama
Query!
Country [224]
0
0
Japan
Query!
State/province [224]
0
0
Kumamoto, Kumamoto
Query!
Country [225]
0
0
Japan
Query!
State/province [225]
0
0
Kumamoto, Yatsushiro
Query!
Country [226]
0
0
Japan
Query!
State/province [226]
0
0
Miyazaki, Miyazaki
Query!
Country [227]
0
0
Japan
Query!
State/province [227]
0
0
Saitama, Hanyu
Query!
Country [228]
0
0
Japan
Query!
State/province [228]
0
0
Tokyo, Itabashi-ku
Query!
Country [229]
0
0
Korea, Republic of
Query!
State/province [229]
0
0
Ansan
Query!
Country [230]
0
0
Korea, Republic of
Query!
State/province [230]
0
0
Busan
Query!
Country [231]
0
0
Korea, Republic of
Query!
State/province [231]
0
0
Daegu
Query!
Country [232]
0
0
Korea, Republic of
Query!
State/province [232]
0
0
Goyang
Query!
Country [233]
0
0
Korea, Republic of
Query!
State/province [233]
0
0
Jeonju
Query!
Country [234]
0
0
Korea, Republic of
Query!
State/province [234]
0
0
Pusan
Query!
Country [235]
0
0
Korea, Republic of
Query!
State/province [235]
0
0
Seongnam
Query!
Country [236]
0
0
Korea, Republic of
Query!
State/province [236]
0
0
Seoul
Query!
Country [237]
0
0
Korea, Republic of
Query!
State/province [237]
0
0
Suwon
Query!
Country [238]
0
0
Korea, Republic of
Query!
State/province [238]
0
0
Wonju
Query!
Country [239]
0
0
Korea, Republic of
Query!
State/province [239]
0
0
Yangsan
Query!
Country [240]
0
0
Malaysia
Query!
State/province [240]
0
0
Johor Bahru, Johor
Query!
Country [241]
0
0
Malaysia
Query!
State/province [241]
0
0
Kota Bharu
Query!
Country [242]
0
0
Malaysia
Query!
State/province [242]
0
0
Kuala Lumpur
Query!
Country [243]
0
0
Malaysia
Query!
State/province [243]
0
0
Kuantan
Query!
Country [244]
0
0
Malaysia
Query!
State/province [244]
0
0
Melaka
Query!
Country [245]
0
0
Malaysia
Query!
State/province [245]
0
0
Penang
Query!
Country [246]
0
0
Malaysia
Query!
State/province [246]
0
0
Taiping
Query!
Country [247]
0
0
Mexico
Query!
State/province [247]
0
0
Acapulco
Query!
Country [248]
0
0
Mexico
Query!
State/province [248]
0
0
Aguascalientes
Query!
Country [249]
0
0
Mexico
Query!
State/province [249]
0
0
Distrito Federal
Query!
Country [250]
0
0
Mexico
Query!
State/province [250]
0
0
Guadalajara
Query!
Country [251]
0
0
Mexico
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Funding & Sponsors
Primary sponsor type
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Name
Boehringer Ingelheim
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Eli Lilly and Company
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Summary
Brief summary
The aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.
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Trial website
https://clinicaltrials.gov/study/NCT01243424
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Trial related presentations / publications
Verhagen C, Janssen J, Minderhoud CA, van den Berg E, Wanner C, Passera A, Johansen OE, Biessels GJ. Chronic kidney disease and cognitive decline in patients with type 2 diabetes at elevated cardiovascular risk. J Diabetes Complications. 2022 Oct;36(10):108303. doi: 10.1016/j.jdiacomp.2022.108303. Epub 2022 Aug 31. Verhagen C, Janssen J, Biessels GJ, Johansen OE, Exalto LG. Females with type 2 diabetes are at higher risk for accelerated cognitive decline than males: CAROLINA-COGNITION study. Nutr Metab Cardiovasc Dis. 2022 Feb;32(2):355-364. doi: 10.1016/j.numecd.2021.10.013. Epub 2021 Oct 27. Biessels GJ, Verhagen C, Janssen J, van den Berg E, Wallenstein G, Zinman B, Espeland MA, Johansen OE. Effects of linagliptin vs glimepiride on cognitive performance in type 2 diabetes: results of the randomised double-blind, active-controlled CAROLINA-COGNITION study. Diabetologia. 2021 Jun;64(6):1235-1245. doi: 10.1007/s00125-021-05393-8. Epub 2021 Feb 9. Rosenstock J, Kahn SE, Johansen OE, Zinman B, Espeland MA, Woerle HJ, Pfarr E, Keller A, Mattheus M, Baanstra D, Meinicke T, George JT, von Eynatten M, McGuire DK, Marx N; CAROLINA Investigators. Effect of Linagliptin vs Glimepiride on Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes: The CAROLINA Randomized Clinical Trial. JAMA. 2019 Sep 24;322(12):1155-1166. doi: 10.1001/jama.2019.13772. Erratum In: JAMA. 2019 Dec 3;322(21):2138. doi: 10.1001/jama.2019.19012. Janssen J, van den Berg E, Zinman B, Espeland MA, Geijselaers SLC, Mattheus M, Johansen OE, Biessels GJ. HbA1c, Insulin Resistance, and beta-Cell Function in Relation to Cognitive Function in Type 2 Diabetes: The CAROLINA Cognition Substudy. Diabetes Care. 2019 Jan;42(1):e1-e3. doi: 10.2337/DC18-0914. No abstract available. Biessels GJ, Janssen J, van den Berg E, Zinman B, Espeland MA, Mattheus M, Johansen OE; CAROLINA(R) investigators. Rationale and design of the CAROLINA(R) - cognition substudy: a randomised controlled trial on cognitive outcomes of linagliptin versus glimepiride in patients with type 2 diabetes mellitus. BMC Neurol. 2018 Jan 15;18(1):7. doi: 10.1186/s12883-018-1014-7. Marx N, Rosenstock J, Kahn SE, Zinman B, Kastelein JJ, Lachin JM, Espeland MA, Bluhmki E, Mattheus M, Ryckaert B, Patel S, Johansen OE, Woerle HJ. Design and baseline characteristics of the CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA(R)). Diab Vasc Dis Res. 2015 May;12(3):164-74. doi: 10.1177/1479164115570301. Epub 2015 Mar 15. Chilton R. Linagliptin versus glimepiride add-on for the long-term treatment of Type 2 diabetes mellitus. Expert Rev Endocrinol Metab. 2013 Jul;8(4):345-349. doi: 10.1586/17446651.2013.811849.
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Public notes
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Contacts
Principal investigator
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Boehringer Ingelheim
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Boehringer Ingelheim
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No information has been provided regarding IPD availability
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No Supporting Document Provided
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/24/NCT01243424/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/24/NCT01243424/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01243424
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