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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/NCT01986881
Registration number
NCT01986881
Ethics application status
Date submitted
12/11/2013
Date registered
19/11/2013
Date last updated
23/09/2022
Titles & IDs
Public title
Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004)
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Scientific title
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Cardiovascular Outcomes Following Treatment With Ertugliflozin (MK-8835/PF-04971729) in Subjects With Type 2 Diabetes Mellitus and Established Vascular Disease, The VERTIS CV Study
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Secondary ID [1]
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2013-002518-11
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Secondary ID [2]
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8835-004
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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:
Type 2 Diabetes Mellitus
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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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 - Ertugliflozin
Treatment: Drugs - Placebo
Treatment: Drugs - Glycemic Rescue
Experimental: Ertugliflozin, 15 mg - Ertugliflozin 15 mg administered orally once daily for up to approximately 6 years
Experimental: Ertugliflozin, 5 mg - Ertugliflozin 5 mg administered orally once daily for up to approximately 6 years
Placebo Comparator: Placebo - Matching placebo to ertugliflozin administered orally once daily for up to approximately 6 years
Treatment: Drugs: Ertugliflozin
Oral, once daily, for up to approximately 6 years
Treatment: Drugs: Placebo
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Treatment: Drugs: Glycemic Rescue
Doses of background anti-hyperglycemic agents (AHA), medications will be required to be held constant in all participants enrolled for the initial 18 weeks of the trial with 2 exceptions: First, participant will be prescribed glycemic rescue therapy if they meet specific, progressively more stringent, glycemic thresholds based on repeated, confirmed fasting plasma glucose (FPG) measured at a central laboratory. Second, a participant experiencing clinically significant hypoglycemia according to the investigator at any time during the trial is permitted to have the dose of appropriate background AHA (e.g., insulin, sulfonylurea [SU], glinide) reduced or discontinued as per the judgment of the investigator or the treating physician. Choice and dosing of glycemic rescue will be at the discretion of the investigator or the treating physician consistent with standards of care for management of patients with Type 2 diabetes mellitus (T2DM) within the country of the investigational site.
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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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Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (On-Treatment + 365-day Approach) (Overall Cardiovascular Study)
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Assessment method [1]
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Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI, and non-fatal stroke. The on-treatment approach included confirmed events that occurred between the date of first dose of study medication and the on-treatment censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, last contact date, or 365 days after the last dose).
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Timepoint [1]
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Up to approximately 6 years
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Primary outcome [2]
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Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
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Assessment method [2]
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A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects the Week 0 A1C.
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Timepoint [2]
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Baseline
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Primary outcome [3]
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Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study)
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Assessment method [3]
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A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
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Timepoint [3]
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Baseline and Week 18
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Primary outcome [4]
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Baseline Hemoglobin A1C (A1C) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
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Assessment method [4]
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A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects the Week 0 A1C.
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Timepoint [4]
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Baseline
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Primary outcome [5]
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Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
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Assessment method [5]
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A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
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Timepoint [5]
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Baseline and Week 18
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Primary outcome [6]
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Baseline Hemoglobin A1C (A1C) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
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Assessment method [6]
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A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects Week 0 A1C.
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Timepoint [6]
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Baseline
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Primary outcome [7]
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Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
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Assessment method [7]
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A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
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Timepoint [7]
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Baseline and Week 18
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Secondary outcome [1]
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Time to Occurrence of Cardiovascular (CV) Death or Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study)
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Assessment method [1]
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Time to the occurrence of any of the following adjudicated components of cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)) or hospitalization for heart failure. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to event or time to censoring (the earliest of participants' end of study date, death date, or last contact date).
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Timepoint [1]
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Up to approximately 6 years
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Secondary outcome [2]
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Time to Occurrence of Cardiovascular Death (On-study Approach) (Overall Cardiovascular Study)
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Assessment method [2]
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Time to the occurrence of cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)). The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to CV death or time to censoring (the earliest of participants' end of study date or date last known to be alive).
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Timepoint [2]
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Up to approximately 6 years
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Secondary outcome [3]
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Time to First Occurrence of the Renal Composite: the Composite of Renal Death, Renal Dialysis/Transplant, or Doubling of Serum Creatinine From Baseline (On-Study Approach) (Overall Cardiovascular Study)
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Assessment method [3]
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Renal composite endpoint was defined as a composite of renal death, renal dialysis/transplant, or doubling of serum creatinine from baseline. The on-study approach included events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date.
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Timepoint [3]
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Up to approximately 6 years
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Secondary outcome [4]
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Time to First Occurrence of MACE Plus (Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke or Hospitalization for Unstable Angina) (On-Study Approach) (Overall Cardiovascular Study)
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Assessment method [4]
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Time to the first occurrence of any of the following adjudicated components 4-point MACE: cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction, non-fatal stroke, and hospitalization for unstable angina pectoris. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date.
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Timepoint [4]
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Up to approximately 6 years
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Secondary outcome [5]
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Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction (On-Study Approach) (Overall Cardiovascular Study)
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Assessment method [5]
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Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date).
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Timepoint [5]
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0
Up to approximately 6 years
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Secondary outcome [6]
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Time to First Occurrence of Fatal or Non-fatal Stroke (FNF Stroke) (On-Study Approach) (Overall Cardiovascular Study)
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Assessment method [6]
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Time to the first occurrence of fatal and no-fatal stroke. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date.
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Timepoint [6]
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Up to approximately 6 years
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Secondary outcome [7]
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Time to First Occurrence of Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study)
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Assessment method [7]
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Time to the first occurrence of heart failure requiring hospitalization (adjudicated). The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date.
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Timepoint [7]
0
0
Up to approximately 6 years
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Secondary outcome [8]
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Time to Occurrence of Death From Any Cause (On-Study Approach) (Overall Cardiovascular Study)
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Assessment method [8]
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Time to the occurrence of death from any cause. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to event or time to censoring (the earliest of participants' end of study date, death date, last contact date, or date last known to be alive. The on-study approach included events that occurred between the randomization date and the on-study censor date.
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Timepoint [8]
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0
Up to approximately 6 years
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Secondary outcome [9]
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Andersen-Gill Model for Total MACE (On-Study Approach) (Overall Cardiovascular Study)
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Assessment method [9]
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All events (first and recurrent) of the composite of MACE (3-point major adverse cardiovascular events: cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI, and non-fatal stroke) were assessed using Andersen-Gill model. The on-study approach included events that occurred between the randomization date and the on-study censor date.
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Timepoint [9]
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Up to approximately 6 years
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Secondary outcome [10]
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Andersen-Gill Model for All Cardiovascular Death (CV Death) or Hospitalizations for Heart Failure (HFF) (On-Study Approach) (Overall Cardiovascular Study)
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Assessment method [10]
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All events (first and recurrent) of the composite of CV death and HHF were assessed using an Andersen-Gill model. Person-years were calculated as the sum of time from randomization to end of follow-up. The on-study approach included events that occurred between the randomization date and the on-study censor date.
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Timepoint [10]
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0
Up to approximately 6 years
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Secondary outcome [11]
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Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Overall Cardiovascular Study)
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Assessment method [11]
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A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
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Timepoint [11]
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Baseline and Week 18
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Secondary outcome [12]
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Change From Baseline in A1C at Week 52 (Overall Cardiovascular Study)
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Assessment method [12]
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A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [12]
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Baseline and Week 52
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Secondary outcome [13]
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Change From Baseline in A1C at Month 24 (Overall Cardiovascular Study)
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Assessment method [13]
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A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 24 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [13]
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Baseline and Month 24
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Secondary outcome [14]
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Change From Baseline in A1C at Month 36 (Overall Cardiovascular Study)
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Assessment method [14]
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A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 36 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [14]
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Baseline and Month 36
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Secondary outcome [15]
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Change From Baseline in A1C at Month 48 (Overall Cardiovascular Study)
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Assessment method [15]
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A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 48 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [15]
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Baseline and Month 48
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Secondary outcome [16]
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Change From Baseline in A1C at Month 60 (Overall Cardiovascular Study)
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Assessment method [16]
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A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 60 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [16]
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Baseline and Month 60
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Secondary outcome [17]
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Change From Baseline in A1C at Month 72 (Overall Cardiovascular Study)
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Assessment method [17]
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A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 72 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [17]
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0
Baseline and Month 72
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Secondary outcome [18]
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Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Overall Cardiovascular Study)
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Assessment method [18]
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A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [18]
0
0
Week 18
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Secondary outcome [19]
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0
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 52 (Overall Cardiovascular Study)
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Assessment method [19]
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A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [19]
0
0
Week 52
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Secondary outcome [20]
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Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 24 (Overall Cardiovascular Study)
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Assessment method [20]
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A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [20]
0
0
Month 24
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Secondary outcome [21]
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0
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 36 (Overall Cardiovascular Study)
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Assessment method [21]
0
0
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [21]
0
0
Month 36
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Secondary outcome [22]
0
0
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 48 (Overall Cardiovascular Study)
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Assessment method [22]
0
0
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [22]
0
0
Month 48
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Secondary outcome [23]
0
0
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 60 (Overall Cardiovascular Study)
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Assessment method [23]
0
0
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [23]
0
0
Month 60
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Secondary outcome [24]
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0
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 18 (Overall Cardiovascular Study)
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Assessment method [24]
0
0
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [24]
0
0
Week 18
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Secondary outcome [25]
0
0
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 52 (Overall Cardiovascular Study)
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Assessment method [25]
0
0
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [25]
0
0
Week 52
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Secondary outcome [26]
0
0
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 24 (Overall Cardiovascular Study)
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Assessment method [26]
0
0
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [26]
0
0
Month 24
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Secondary outcome [27]
0
0
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 36 (Overall Cardiovascular Study)
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Assessment method [27]
0
0
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [27]
0
0
Month 36
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Secondary outcome [28]
0
0
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 48 (Overall Cardiovascular Study)
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Assessment method [28]
0
0
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [28]
0
0
Month 48
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Secondary outcome [29]
0
0
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 60 (Overall Cardiovascular Study)
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Assessment method [29]
0
0
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [29]
0
0
Month 60
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Secondary outcome [30]
0
0
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
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Assessment method [30]
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0
FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding rescue", excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
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Timepoint [30]
0
0
Baseline and Week 18
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Secondary outcome [31]
0
0
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Overall Cardiovascular Study)
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Assessment method [31]
0
0
FPG was analyzed after an overnight fast. This change from baseline reflects the Week 52 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [31]
0
0
Baseline and Week 52
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Secondary outcome [32]
0
0
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 24 (Overall Cardiovascular Study)
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Assessment method [32]
0
0
FPG was analyzed after an overnight fast. This change from baseline reflects the Month 24 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [32]
0
0
Baseline and Month 24
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Secondary outcome [33]
0
0
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 36 (Overall Cardiovascular Study)
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Assessment method [33]
0
0
FPG was analyzed after an overnight fast. This change from baseline reflects the Month 36 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [33]
0
0
Baseline and Month 36
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Secondary outcome [34]
0
0
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 48 (Overall Cardiovascular Study)
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Assessment method [34]
0
0
FPG was analyzed after an overnight fast. This change from baseline reflects the Month 48 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [34]
0
0
Baseline and Month 48
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Secondary outcome [35]
0
0
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 60 (Overall Cardiovascular Study)
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Assessment method [35]
0
0
FPG was analyzed after an overnight fast. This change from baseline reflects the Month 60 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [35]
0
0
Baseline and Month 60
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Secondary outcome [36]
0
0
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 72 (Overall Cardiovascular Study)
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Assessment method [36]
0
0
FPG was analyzed after an overnight fast. This change from baseline reflects the Month 72 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
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Timepoint [36]
0
0
Baseline and Month 72
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Secondary outcome [37]
0
0
Time to the First Occurrence of a Participant Receiving Glycemic Rescue Therapy Through Week 18 (Overall Cardiovascular Study)
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Assessment method [37]
0
0
Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.
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Timepoint [37]
0
0
Up to 18 weeks
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Secondary outcome [38]
0
0
Time to Initiation of Insulin for Participants Not on Insulin at Baseline (Overall Cardiovascular Study)
Query!
Assessment method [38]
0
0
Participants who were not on insulin therapy at the start of study medication.
Query!
Timepoint [38]
0
0
Up to approximately 6 years
Query!
Secondary outcome [39]
0
0
Baseline Insulin Dose for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
Query!
Assessment method [39]
0
0
Baseline reflects Week 0 insulin dose.
Query!
Timepoint [39]
0
0
Baseline
Query!
Secondary outcome [40]
0
0
Change From Baseline in Insulin Dose at Week 18 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
Query!
Assessment method [40]
0
0
This change from baseline reflects the Week 18 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Query!
Timepoint [40]
0
0
Baseline and Week 18
Query!
Secondary outcome [41]
0
0
Change From Baseline in Insulin Dose at Week 52 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
Query!
Assessment method [41]
0
0
This change from baseline reflects the Week 52 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Query!
Timepoint [41]
0
0
Baseline and Week 52
Query!
Secondary outcome [42]
0
0
Change From Baseline in Insulin Dose at Month 24 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
Query!
Assessment method [42]
0
0
This change from baseline reflects the Month 24 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Query!
Timepoint [42]
0
0
Baseline and Month 24
Query!
Secondary outcome [43]
0
0
Change From Baseline in Insulin Dose at Month 36 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
Query!
Assessment method [43]
0
0
This change from baseline reflects the Month 36 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Query!
Timepoint [43]
0
0
Baseline and Month 36
Query!
Secondary outcome [44]
0
0
Change From Baseline in Insulin Dose at Month 48 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
Query!
Assessment method [44]
0
0
This change from baseline reflects the Month 48 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Query!
Timepoint [44]
0
0
Baseline and Month 48
Query!
Secondary outcome [45]
0
0
Change From Baseline in Insulin Dose at Month 60 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
Query!
Assessment method [45]
0
0
This change from baseline reflects the Month 60 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Query!
Timepoint [45]
0
0
Baseline and Month 60
Query!
Secondary outcome [46]
0
0
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
Query!
Assessment method [46]
0
0
This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding rescue", excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [46]
0
0
Baseline and Week 18
Query!
Secondary outcome [47]
0
0
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 (Overall Cardiovascular Study)
Query!
Assessment method [47]
0
0
This change from baseline reflects the Week 52 sitting SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [47]
0
0
Baseline and Week 52
Query!
Secondary outcome [48]
0
0
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 24 (Overall Cardiovascular Study)
Query!
Assessment method [48]
0
0
This change from baseline reflects the Month 24 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [48]
0
0
Baseline and Month 24
Query!
Secondary outcome [49]
0
0
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 36 (Overall Cardiovascular Study)
Query!
Assessment method [49]
0
0
This change from baseline reflects the Month 36 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [49]
0
0
Baseline and Month 36
Query!
Secondary outcome [50]
0
0
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 48 (Overall Cardiovascular Study)
Query!
Assessment method [50]
0
0
This change from baseline reflects the Month 48 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [50]
0
0
Baseline and Month 48
Query!
Secondary outcome [51]
0
0
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 60 (Overall Cardiovascular Study)
Query!
Assessment method [51]
0
0
This change from baseline reflects the Month 60 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [51]
0
0
Baseline and Month 60
Query!
Secondary outcome [52]
0
0
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 72 (Overall Cardiovascular Study)
Query!
Assessment method [52]
0
0
This change from baseline reflects the Month 72 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [52]
0
0
Baseline and Month 72
Query!
Secondary outcome [53]
0
0
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
Query!
Assessment method [53]
0
0
This change from baseline reflects the Week 18 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding rescue", excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [53]
0
0
Baseline and Week 18
Query!
Secondary outcome [54]
0
0
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 52 (Overall Cardiovascular Study)
Query!
Assessment method [54]
0
0
This change from baseline reflects the Week 52 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [54]
0
0
Baseline and Week 52
Query!
Secondary outcome [55]
0
0
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 24 (Overall Cardiovascular Study)
Query!
Assessment method [55]
0
0
This change from baseline reflects the Month 24 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [55]
0
0
Baseline and Month 24
Query!
Secondary outcome [56]
0
0
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 36 (Overall Cardiovascular Study)
Query!
Assessment method [56]
0
0
This change from baseline reflects the Month 36 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [56]
0
0
Baseline and Month 36
Query!
Secondary outcome [57]
0
0
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 48 (Overall Cardiovascular Study)
Query!
Assessment method [57]
0
0
This change from baseline reflects the Month 48 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [57]
0
0
Baseline and Month 48
Query!
Secondary outcome [58]
0
0
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 60 (Overall Cardiovascular Study)
Query!
Assessment method [58]
0
0
This change from baseline reflects the Month 60 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [58]
0
0
Baseline and Month 60
Query!
Secondary outcome [59]
0
0
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 72 (Overall Cardiovascular Study)
Query!
Assessment method [59]
0
0
This change from baseline reflects the Month 72 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [59]
0
0
Baseline and Month 72
Query!
Secondary outcome [60]
0
0
Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
Query!
Assessment method [60]
0
0
This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [60]
0
0
Baseline and Week 18
Query!
Secondary outcome [61]
0
0
Change From Baseline in Body Weight at Week 52 (Overall Cardiovascular Study)
Query!
Assessment method [61]
0
0
This change from baseline reflects the Week 52 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [61]
0
0
Baseline and Week 52
Query!
Secondary outcome [62]
0
0
Change From Baseline in Body Weight at Month 24 (Overall Cardiovascular Study)
Query!
Assessment method [62]
0
0
This change from baseline reflects the Month 24 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [62]
0
0
Baseline and Month 24
Query!
Secondary outcome [63]
0
0
Change From Baseline in Body Weight at Month 36 (Overall Cardiovascular Study)
Query!
Assessment method [63]
0
0
This change from baseline reflects the Month 36 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [63]
0
0
Baseline and Month 36
Query!
Secondary outcome [64]
0
0
Change From Baseline in Body Weight at Month 48 (Overall Cardiovascular Study)
Query!
Assessment method [64]
0
0
This change from baseline reflects the Month 48 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [64]
0
0
Baseline and Month 48
Query!
Secondary outcome [65]
0
0
Change From Baseline in Body Weight at Month 60 (Overall Cardiovascular Study)
Query!
Assessment method [65]
0
0
This change from baseline reflects the Month 60 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [65]
0
0
Baseline and Month 60
Query!
Secondary outcome [66]
0
0
Change From Baseline in Body Weight at Month 72 (Overall Cardiovascular Study)
Query!
Assessment method [66]
0
0
This change from baseline reflects the Month 72 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [66]
0
0
Baseline and Month 72
Query!
Secondary outcome [67]
0
0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 18 (Overall Cardiovascular Study)
Query!
Assessment method [67]
0
0
This change from baseline reflects the Week 18 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level.
Query!
Timepoint [67]
0
0
Baseline and Week 18
Query!
Secondary outcome [68]
0
0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 (Overall Cardiovascular Study)
Query!
Assessment method [68]
0
0
This change from baseline reflects the Week 52 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in eGFR level.
Query!
Timepoint [68]
0
0
Baseline and Week 52
Query!
Secondary outcome [69]
0
0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 24 (Overall Cardiovascular Study)
Query!
Assessment method [69]
0
0
This change from baseline reflects the Month 24 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level.
Query!
Timepoint [69]
0
0
Baseline and Month 24
Query!
Secondary outcome [70]
0
0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 36 (Overall Cardiovascular Study)
Query!
Assessment method [70]
0
0
This change from baseline reflects the Month 36 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level.
Query!
Timepoint [70]
0
0
Baseline and Month 36
Query!
Secondary outcome [71]
0
0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 48 (Overall Cardiovascular Study)
Query!
Assessment method [71]
0
0
This change from baseline reflects the Month 48 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in eGFR level.
Query!
Timepoint [71]
0
0
Baseline and Month 48
Query!
Secondary outcome [72]
0
0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 60 (Overall Cardiovascular Study)
Query!
Assessment method [72]
0
0
This change from baseline reflects the Month 60 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level.
Query!
Timepoint [72]
0
0
Baseline and Month 60
Query!
Secondary outcome [73]
0
0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 72 (Overall Cardiovascular Study)
Query!
Assessment method [73]
0
0
This change from baseline reflects the Month 72 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level.
Query!
Timepoint [73]
0
0
Baseline and Month 72
Query!
Secondary outcome [74]
0
0
Baseline Serum Creatinine (Overall Cardiovascular Study)
Query!
Assessment method [74]
0
0
Baseline reflects Week 0 serum creatinine.
Query!
Timepoint [74]
0
0
Baseline
Query!
Secondary outcome [75]
0
0
Change From Baseline in Serum Creatinine at Week 18 (Overall Cardiovascular Study)
Query!
Assessment method [75]
0
0
This change from baseline reflects the Week 18 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [75]
0
0
Baseline and Week 18
Query!
Secondary outcome [76]
0
0
Change From Baseline in Serum Creatinine at Week 52 (Overall Cardiovascular Study)
Query!
Assessment method [76]
0
0
This change from baseline reflects the Week 52 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [76]
0
0
Baseline and Week 52
Query!
Secondary outcome [77]
0
0
Change From Baseline in Serum Creatinine at Month 24 (Overall Cardiovascular Study)
Query!
Assessment method [77]
0
0
This change from baseline reflects the Month 24 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [77]
0
0
Baseline and Month 24
Query!
Secondary outcome [78]
0
0
Change From Baseline in Serum Creatinine at Month 36 (Overall Cardiovascular Study)
Query!
Assessment method [78]
0
0
This change from baseline reflects the Month 36 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [78]
0
0
Baseline and Month 36
Query!
Secondary outcome [79]
0
0
Change From Baseline in Serum Creatinine at Month 48 (Overall Cardiovascular Study)
Query!
Assessment method [79]
0
0
This change from baseline reflects the Month 48 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [79]
0
0
Baseline and Month 48
Query!
Secondary outcome [80]
0
0
Change From Baseline in Serum Creatinine at Month 60 (Overall Cardiovascular Study)
Query!
Assessment method [80]
0
0
This change from baseline reflects the Month 60 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [80]
0
0
Baseline and Month 60
Query!
Secondary outcome [81]
0
0
Change From Baseline in Serum Creatinine at Month 72 (Overall Cardiovascular Study)
Query!
Assessment method [81]
0
0
This change from baseline reflects the Month 72 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [81]
0
0
Baseline and Month 72
Query!
Secondary outcome [82]
0
0
Baseline Urinary Albumin/Creatinine Ratio (Overall Cardiovascular Study)
Query!
Assessment method [82]
0
0
Baseline reflects Week 0 albumin/creatinine ratio.
Query!
Timepoint [82]
0
0
Baseline
Query!
Secondary outcome [83]
0
0
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 18 (Overall Cardiovascular Study)
Query!
Assessment method [83]
0
0
This percent change relative to baseline reflects the Week 18 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in the urinary albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [83]
0
0
Baseline and Week 18
Query!
Secondary outcome [84]
0
0
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 52 (Overall Cardiovascular Study)
Query!
Assessment method [84]
0
0
This percent change relative to baseline reflects the Week 52 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in the albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [84]
0
0
Baseline and Week 52
Query!
Secondary outcome [85]
0
0
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 24 (Overall Cardiovascular Study)
Query!
Assessment method [85]
0
0
This percent change relative to baseline reflects the Month 24 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in urinary albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [85]
0
0
Baseline and Month 24
Query!
Secondary outcome [86]
0
0
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 36 (Overall Cardiovascular Study)
Query!
Assessment method [86]
0
0
This percent change relative to baseline reflects the Month 36 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in urinary albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [86]
0
0
Baseline and Month 36
Query!
Secondary outcome [87]
0
0
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 48 (Overall Cardiovascular Study)
Query!
Assessment method [87]
0
0
This percent change relative to baseline reflects the Month 48 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [87]
0
0
Baseline and Month 48
Query!
Secondary outcome [88]
0
0
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 60 (Overall Cardiovascular Study)
Query!
Assessment method [88]
0
0
This percent change relative to baseline reflects the Month 60 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.
Query!
Timepoint [88]
0
0
Baseline and Month 60
Query!
Secondary outcome [89]
0
0
Percentage of Participants With Albuminuria Progression or Regression at Week 18 (Overall Cardiovascular Study)
Query!
Assessment method [89]
0
0
Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal-albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR =30 and =300 (mg/g); Macro-albuminuria: UACR>300 (mg/g).
Query!
Timepoint [89]
0
0
Week 18
Query!
Secondary outcome [90]
0
0
Percentage of Participants With Albuminuria Progression or Regression at Week 52 (Overall Cardiovascular Study)
Query!
Assessment method [90]
0
0
Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR =30 and =300 (mg/g); Macro-albuminuria: UACR>300 (mg/g).
Query!
Timepoint [90]
0
0
Week 52
Query!
Secondary outcome [91]
0
0
Percentage of Participants With Albuminuria Progression or Regression at Month 24 (Overall Cardiovascular Study)
Query!
Assessment method [91]
0
0
Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR =30 and =300 (mg/g); Macro-albuminuria: UACR>300 (mg/g).
Query!
Timepoint [91]
0
0
Month 24
Query!
Secondary outcome [92]
0
0
Percentage of Participants With Albuminuria Progression or Regression at Month 36 (Overall Cardiovascular Study)
Query!
Assessment method [92]
0
0
Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR =30 and =300 (mg/g); Macro-albuminuria: UACR>300 (mg/g).
Query!
Timepoint [92]
0
0
Month 36
Query!
Secondary outcome [93]
0
0
Percentage of Participants With Albuminuria Progression or Regression at Month 48 (Overall Cardiovascular Study)
Query!
Assessment method [93]
0
0
Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline and normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR =30 and =300 (mg/g); Macro-albuminuria: UACR>300 (mg/g).
Query!
Timepoint [93]
0
0
Month 48
Query!
Secondary outcome [94]
0
0
Percentage of Participants With Albuminuria Progression or Regression at Month 60 (Overall Cardiovascular Study)
Query!
Assessment method [94]
0
0
Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR =30 and =300 (mg/g); Macro-albuminuria: UACR>300 (mg/g).
Query!
Timepoint [94]
0
0
Month 60
Query!
Secondary outcome [95]
0
0
Percentage of Participants Experiencing an Adverse Event (AE) (Overall Cardiovascular Study)
Query!
Assessment method [95]
0
0
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Query!
Timepoint [95]
0
0
Up to approximately 6 years
Query!
Secondary outcome [96]
0
0
Percentage of Participants Experiencing an Adverse Event (AE) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
Query!
Assessment method [96]
0
0
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Query!
Timepoint [96]
0
0
Up to 18 weeks
Query!
Secondary outcome [97]
0
0
Percentage of Participants Experiencing an Adverse Event (AE) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
Query!
Assessment method [97]
0
0
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Query!
Timepoint [97]
0
0
Up to 18 weeks
Query!
Secondary outcome [98]
0
0
Percentage of Participants Experiencing an Adverse Event (AE) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
Query!
Assessment method [98]
0
0
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Query!
Timepoint [98]
0
0
Up to 18 weeks
Query!
Secondary outcome [99]
0
0
Percentage of Participants Discontinuing Study Treatment Due to An AE (Overall Cardiovascular Study)
Query!
Assessment method [99]
0
0
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Query!
Timepoint [99]
0
0
Up to approximately 6 years
Query!
Secondary outcome [100]
0
0
Percentage of Participants Discontinuing Study Treatment Due to An AE (Insulin With or Without Metformin Add-on Glycemic Sub-study)
Query!
Assessment method [100]
0
0
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Query!
Timepoint [100]
0
0
Up to 18 weeks
Query!
Secondary outcome [101]
0
0
Percentage of Participants Discontinuing Study Treatment Due to An AE (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
Query!
Assessment method [101]
0
0
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Query!
Timepoint [101]
0
0
Up to 18 weeks
Query!
Secondary outcome [102]
0
0
Percentage of Participants Discontinuing Study Treatment Due to An AE (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
Query!
Assessment method [102]
0
0
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Query!
Timepoint [102]
0
0
Up to 18 weeks
Query!
Secondary outcome [103]
0
0
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
Query!
Assessment method [103]
0
0
FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in the FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [103]
0
0
Baseline and Week 18
Query!
Secondary outcome [104]
0
0
Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
Query!
Assessment method [104]
0
0
This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [104]
0
0
Baseline and Week 18
Query!
Secondary outcome [105]
0
0
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
Query!
Assessment method [105]
0
0
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [105]
0
0
Week 18
Query!
Secondary outcome [106]
0
0
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
Query!
Assessment method [106]
0
0
This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [106]
0
0
Baseline and Week 18
Query!
Secondary outcome [107]
0
0
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
Query!
Assessment method [107]
0
0
This change from baseline reflects the Week 18 DBP minus the Week 0 BBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [107]
0
0
Baseline and Week 18
Query!
Secondary outcome [108]
0
0
Baseline Insulin Dose for Participants Receiving Insulin at Baseline - (Insulin With or Without Metformin Add-on Glycemic Sub-study)
Query!
Assessment method [108]
0
0
Baseline reflects Week 0 insulin dose.
Query!
Timepoint [108]
0
0
Baseline
Query!
Secondary outcome [109]
0
0
Change From Baseline at Week 18 in Insulin Dose for Participants Receiving Insulin at Baseline - Including Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study)
Query!
Assessment method [109]
0
0
This change from baseline reflects the Week 18 insulin dose minus the Week 0 insulin dose. A negative number indicates a decrease in insulin dose. Participants who met glycemic rescue criteria received glycemic rescue medication. "Including rescue", included data following the initiation of rescue therapy.
Query!
Timepoint [109]
0
0
Baseline and Week 18
Query!
Secondary outcome [110]
0
0
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
Query!
Assessment method [110]
0
0
FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [110]
0
0
Baseline and Week 18
Query!
Secondary outcome [111]
0
0
Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
Query!
Assessment method [111]
0
0
This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [111]
0
0
Baseline and Week 18
Query!
Secondary outcome [112]
0
0
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
Query!
Assessment method [112]
0
0
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [112]
0
0
Week 18
Query!
Secondary outcome [113]
0
0
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
Query!
Assessment method [113]
0
0
This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [113]
0
0
Baseline and Week 18
Query!
Secondary outcome [114]
0
0
Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
Query!
Assessment method [114]
0
0
This change from baseline reflects the Week 18 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [114]
0
0
Baseline and Week 18
Query!
Secondary outcome [115]
0
0
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
Query!
Assessment method [115]
0
0
FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [115]
0
0
Baseline and Week 18
Query!
Secondary outcome [116]
0
0
Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
Query!
Assessment method [116]
0
0
This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [116]
0
0
Baseline and Week 18
Query!
Secondary outcome [117]
0
0
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
Query!
Assessment method [117]
0
0
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [117]
0
0
Week 18
Query!
Secondary outcome [118]
0
0
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
Query!
Assessment method [118]
0
0
This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [118]
0
0
Baseline and Week 18
Query!
Secondary outcome [119]
0
0
Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
Query!
Assessment method [119]
0
0
This change from baseline reflects the Week 18 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Query!
Timepoint [119]
0
0
Baseline and Week 18
Query!
Eligibility
Key inclusion criteria
Inclusion Criteria (Overall Cardiovascular Study):
- Diagnosis of T2DM in accordance with American Diabetes Association (ADA) guidelines
- Hemoglobin A1c (A1C) at the start of study participation of 7.0-10.5% (53-91 mmol/mol)
- On stable allowable anti-hyperglycemic agents (AHA) or on no background AHA for at
least 8 weeks prior to the study participation
- Body Mass Index (BMI) > or = to 18.0 kg/m^2
- Evidence or a history of atherosclerosis involving the coronary, cerebral or
peripheral vascular systems
- There is adequate documentation of the objective evidence that the participant has
established vascular disease such as investigational site's medical records, copies of
such records from other institutions, or a letter from a referring physician that
specifically states the diagnosis and date of the most recent occurrence of the
qualifying event(s) or procedure(s).
- Male, female not or reproductive potential, or female of reproductive potential who
agrees to be abstinent from heterosexual activity or agrees to use or have their
partner use 2 acceptable methods of contraception
Query!
Minimum age
40
Years
Query!
Query!
Maximum age
No limit
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Query!
Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria (Overall Cardiovascular Study):
- Previous randomization into this trial
- Experiencing a cardiovascular event (myocardial infarction or stroke) or undergoing
coronary angioplasty or peripheral intervention procedure between the Screening Visit
and randomization
- Undergoing any cardiovascular surgery (valvular surgery) within 3 months of study
participation
- Planned revascularization or peripheral intervention procedure or other cardiovascular
surgery
- New York Heart Association (NYHA) IV heart failure at study participation
- History of type 1 diabetes mellitus or a history of ketoacidosis
Key Inclusion Criteria for the 3 Glycemic Sub-studies:
1. Insulin With or Without Metformin Sub-study: Stable doses of insulin (>=20 units/day,
with variations up to 10% in the daily dose permitted) with or without metformin
(>=1500 mg/day) for at least 8 weeks prior to the time of the Screening Visit (V1) and
during the period between the Screening Visit (V1) and randomization.
2. Sulfonylurea (SU) Monotherapy Sub-study: Participants receiving a stable dose of SU
monotherapy for at least 8 weeks prior to the time of the Screening Visit (V1) and
during the period between the Screening Visit (V1) and randomization.
3. Metformin with SU Sub-study: Participants receiving a stable dose metformin (=1500
mg/day) with a SU for at least 8 weeks prior to the time of the Screening Visit (V1)
and during the period between the Screening Visit (V1) and randomization.
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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)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Query!
Query!
Query!
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
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
4/11/2013
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Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
27/12/2019
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Sample size
Target
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Accrual to date
Query!
Final
8246
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Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Merck Sharp & Dohme LLC
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Address
Query!
Country
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Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Pfizer
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
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Summary
Brief summary
An overall study of the cardiovascular outcomes following treatment with ertugliflozin in
participants with type 2 diabetes mellitus (T2DM) and established vascular disease. The main
objective of this study is to assess the cardiovascular safety of ertugliflozin. This trial
includes 3 pre-defined glycemic sub-studies; 1. In participants receiving background insulin
with or without metformin, 2. In participants receiving background sulfonylurea monotherapy,
and 3. In participants receiving background metformin with sulfonylurea (all fully-enrolled).
Participants enrolled prior to Amendment 1 were in the overall study as well as a sub-study,
if they met certain entry criteria. Participants enrolled following the start of Amendment 1
were only enrolled in the overall study. The sub-studies were the initial 18 weeks of the
overall study period.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01986881
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Trial related presentations / publications
Cannon CP, McGuire DK, Pratley R, Dagogo-Jack S, Mancuso J, Huyck S, Charbonnel B, Shih WJ, Gallo S, Masiukiewicz U, Golm G, Cosentino F, Lauring B, Terra SG; VERTIS-CV Investigators. Design and baseline characteristics of the eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes trial (VERTIS-CV). Am Heart J. 2018 Dec;206:11-23. doi: 10.1016/j.ahj.2018.08.016. Epub 2018 Sep 5.
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
0
0
Medical Director
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Address
0
0
Merck Sharp & Dohme LLC
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Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01986881
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