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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01986881




Registration number
NCT01986881
Ethics application status
Date submitted
12/11/2013
Date registered
19/11/2013

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)
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
Secondary ID [1] 0 0
2013-002518-11
Secondary ID [2] 0 0
8835-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Up to approximately 6 years
Primary outcome [2] 0 0
Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
Timepoint [2] 0 0
Baseline
Primary outcome [3] 0 0
Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study)
Timepoint [3] 0 0
Baseline and Week 18
Primary outcome [4] 0 0
Baseline Hemoglobin A1C (A1C) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
Timepoint [4] 0 0
Baseline
Primary outcome [5] 0 0
Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
Timepoint [5] 0 0
Baseline and Week 18
Primary outcome [6] 0 0
Baseline Hemoglobin A1C (A1C) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
Timepoint [6] 0 0
Baseline
Primary outcome [7] 0 0
Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
Timepoint [7] 0 0
Baseline and Week 18
Secondary outcome [1] 0 0
Time to Occurrence of Cardiovascular (CV) Death or Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study)
Timepoint [1] 0 0
Up to approximately 6 years
Secondary outcome [2] 0 0
Time to Occurrence of Cardiovascular Death (On-study Approach) (Overall Cardiovascular Study)
Timepoint [2] 0 0
Up to approximately 6 years
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
Up to approximately 6 years
Secondary outcome [4] 0 0
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)
Timepoint [4] 0 0
Up to approximately 6 years
Secondary outcome [5] 0 0
Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction (On-Study Approach) (Overall Cardiovascular Study)
Timepoint [5] 0 0
Up to approximately 6 years
Secondary outcome [6] 0 0
Time to First Occurrence of Fatal or Non-fatal Stroke (FNF Stroke) (On-Study Approach) (Overall Cardiovascular Study)
Timepoint [6] 0 0
Up to approximately 6 years
Secondary outcome [7] 0 0
Time to First Occurrence of Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study)
Timepoint [7] 0 0
Up to approximately 6 years
Secondary outcome [8] 0 0
Time to Occurrence of Death From Any Cause (On-Study Approach) (Overall Cardiovascular Study)
Timepoint [8] 0 0
Up to approximately 6 years
Secondary outcome [9] 0 0
Andersen-Gill Model for Total MACE (On-Study Approach) (Overall Cardiovascular Study)
Timepoint [9] 0 0
Up to approximately 6 years
Secondary outcome [10] 0 0
Andersen-Gill Model for All Cardiovascular Death (CV Death) or Hospitalizations for Heart Failure (HFF) (On-Study Approach) (Overall Cardiovascular Study)
Timepoint [10] 0 0
Up to approximately 6 years
Secondary outcome [11] 0 0
Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Overall Cardiovascular Study)
Timepoint [11] 0 0
Baseline and Week 18
Secondary outcome [12] 0 0
Change From Baseline in A1C at Week 52 (Overall Cardiovascular Study)
Timepoint [12] 0 0
Baseline and Week 52
Secondary outcome [13] 0 0
Change From Baseline in A1C at Month 24 (Overall Cardiovascular Study)
Timepoint [13] 0 0
Baseline and Month 24
Secondary outcome [14] 0 0
Change From Baseline in A1C at Month 36 (Overall Cardiovascular Study)
Timepoint [14] 0 0
Baseline and Month 36
Secondary outcome [15] 0 0
Change From Baseline in A1C at Month 48 (Overall Cardiovascular Study)
Timepoint [15] 0 0
Baseline and Month 48
Secondary outcome [16] 0 0
Change From Baseline in A1C at Month 60 (Overall Cardiovascular Study)
Timepoint [16] 0 0
Baseline and Month 60
Secondary outcome [17] 0 0
Change From Baseline in A1C at Month 72 (Overall Cardiovascular Study)
Timepoint [17] 0 0
Baseline and Month 72
Secondary outcome [18] 0 0
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Overall Cardiovascular Study)
Timepoint [18] 0 0
Week 18
Secondary outcome [19] 0 0
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 52 (Overall Cardiovascular Study)
Timepoint [19] 0 0
Week 52
Secondary outcome [20] 0 0
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 24 (Overall Cardiovascular Study)
Timepoint [20] 0 0
Month 24
Secondary outcome [21] 0 0
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 36 (Overall Cardiovascular Study)
Timepoint [21] 0 0
Month 36
Secondary outcome [22] 0 0
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 48 (Overall Cardiovascular Study)
Timepoint [22] 0 0
Month 48
Secondary outcome [23] 0 0
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 60 (Overall Cardiovascular Study)
Timepoint [23] 0 0
Month 60
Secondary outcome [24] 0 0
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 18 (Overall Cardiovascular Study)
Timepoint [24] 0 0
Week 18
Secondary outcome [25] 0 0
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 52 (Overall Cardiovascular Study)
Timepoint [25] 0 0
Week 52
Secondary outcome [26] 0 0
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 24 (Overall Cardiovascular Study)
Timepoint [26] 0 0
Month 24
Secondary outcome [27] 0 0
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 36 (Overall Cardiovascular Study)
Timepoint [27] 0 0
Month 36
Secondary outcome [28] 0 0
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 48 (Overall Cardiovascular Study)
Timepoint [28] 0 0
Month 48
Secondary outcome [29] 0 0
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 60 (Overall Cardiovascular Study)
Timepoint [29] 0 0
Month 60
Secondary outcome [30] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
Timepoint [30] 0 0
Baseline and Week 18
Secondary outcome [31] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Overall Cardiovascular Study)
Timepoint [31] 0 0
Baseline and Week 52
Secondary outcome [32] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 24 (Overall Cardiovascular Study)
Timepoint [32] 0 0
Baseline and Month 24
Secondary outcome [33] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 36 (Overall Cardiovascular Study)
Timepoint [33] 0 0
Baseline and Month 36
Secondary outcome [34] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 48 (Overall Cardiovascular Study)
Timepoint [34] 0 0
Baseline and Month 48
Secondary outcome [35] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 60 (Overall Cardiovascular Study)
Timepoint [35] 0 0
Baseline and Month 60
Secondary outcome [36] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 72 (Overall Cardiovascular Study)
Timepoint [36] 0 0
Baseline and Month 72
Secondary outcome [37] 0 0
Time to the First Occurrence of a Participant Receiving Glycemic Rescue Therapy Through Week 18 (Overall Cardiovascular Study)
Timepoint [37] 0 0
Up to 18 weeks
Secondary outcome [38] 0 0
Time to Initiation of Insulin for Participants Not on Insulin at Baseline (Overall Cardiovascular Study)
Timepoint [38] 0 0
Up to approximately 6 years
Secondary outcome [39] 0 0
Baseline Insulin Dose for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
Timepoint [39] 0 0
Baseline
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)
Timepoint [40] 0 0
Baseline and Week 18
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)
Timepoint [41] 0 0
Baseline and Week 52
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)
Timepoint [42] 0 0
Baseline and Month 24
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)
Timepoint [43] 0 0
Baseline and Month 36
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)
Timepoint [44] 0 0
Baseline and Month 48
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)
Timepoint [45] 0 0
Baseline and Month 60
Secondary outcome [46] 0 0
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
Timepoint [46] 0 0
Baseline and Week 18
Secondary outcome [47] 0 0
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 (Overall Cardiovascular Study)
Timepoint [47] 0 0
Baseline and Week 52
Secondary outcome [48] 0 0
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 24 (Overall Cardiovascular Study)
Timepoint [48] 0 0
Baseline and Month 24
Secondary outcome [49] 0 0
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 36 (Overall Cardiovascular Study)
Timepoint [49] 0 0
Baseline and Month 36
Secondary outcome [50] 0 0
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 48 (Overall Cardiovascular Study)
Timepoint [50] 0 0
Baseline and Month 48
Secondary outcome [51] 0 0
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 60 (Overall Cardiovascular Study)
Timepoint [51] 0 0
Baseline and Month 60
Secondary outcome [52] 0 0
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 72 (Overall Cardiovascular Study)
Timepoint [52] 0 0
Baseline and Month 72
Secondary outcome [53] 0 0
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
Timepoint [53] 0 0
Baseline and Week 18
Secondary outcome [54] 0 0
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 52 (Overall Cardiovascular Study)
Timepoint [54] 0 0
Baseline and Week 52
Secondary outcome [55] 0 0
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 24 (Overall Cardiovascular Study)
Timepoint [55] 0 0
Baseline and Month 24
Secondary outcome [56] 0 0
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 36 (Overall Cardiovascular Study)
Timepoint [56] 0 0
Baseline and Month 36
Secondary outcome [57] 0 0
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 48 (Overall Cardiovascular Study)
Timepoint [57] 0 0
Baseline and Month 48
Secondary outcome [58] 0 0
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 60 (Overall Cardiovascular Study)
Timepoint [58] 0 0
Baseline and Month 60
Secondary outcome [59] 0 0
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 72 (Overall Cardiovascular Study)
Timepoint [59] 0 0
Baseline and Month 72
Secondary outcome [60] 0 0
Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
Timepoint [60] 0 0
Baseline and Week 18
Secondary outcome [61] 0 0
Change From Baseline in Body Weight at Week 52 (Overall Cardiovascular Study)
Timepoint [61] 0 0
Baseline and Week 52
Secondary outcome [62] 0 0
Change From Baseline in Body Weight at Month 24 (Overall Cardiovascular Study)
Timepoint [62] 0 0
Baseline and Month 24
Secondary outcome [63] 0 0
Change From Baseline in Body Weight at Month 36 (Overall Cardiovascular Study)
Timepoint [63] 0 0
Baseline and Month 36
Secondary outcome [64] 0 0
Change From Baseline in Body Weight at Month 48 (Overall Cardiovascular Study)
Timepoint [64] 0 0
Baseline and Month 48
Secondary outcome [65] 0 0
Change From Baseline in Body Weight at Month 60 (Overall Cardiovascular Study)
Timepoint [65] 0 0
Baseline and Month 60
Secondary outcome [66] 0 0
Change From Baseline in Body Weight at Month 72 (Overall Cardiovascular Study)
Timepoint [66] 0 0
Baseline and Month 72
Secondary outcome [67] 0 0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 18 (Overall Cardiovascular Study)
Timepoint [67] 0 0
Baseline and Week 18
Secondary outcome [68] 0 0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 (Overall Cardiovascular Study)
Timepoint [68] 0 0
Baseline and Week 52
Secondary outcome [69] 0 0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 24 (Overall Cardiovascular Study)
Timepoint [69] 0 0
Baseline and Month 24
Secondary outcome [70] 0 0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 36 (Overall Cardiovascular Study)
Timepoint [70] 0 0
Baseline and Month 36
Secondary outcome [71] 0 0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 48 (Overall Cardiovascular Study)
Timepoint [71] 0 0
Baseline and Month 48
Secondary outcome [72] 0 0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 60 (Overall Cardiovascular Study)
Timepoint [72] 0 0
Baseline and Month 60
Secondary outcome [73] 0 0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 72 (Overall Cardiovascular Study)
Timepoint [73] 0 0
Baseline and Month 72
Secondary outcome [74] 0 0
Baseline Serum Creatinine (Overall Cardiovascular Study)
Timepoint [74] 0 0
Baseline
Secondary outcome [75] 0 0
Change From Baseline in Serum Creatinine at Week 18 (Overall Cardiovascular Study)
Timepoint [75] 0 0
Baseline and Week 18
Secondary outcome [76] 0 0
Change From Baseline in Serum Creatinine at Week 52 (Overall Cardiovascular Study)
Timepoint [76] 0 0
Baseline and Week 52
Secondary outcome [77] 0 0
Change From Baseline in Serum Creatinine at Month 24 (Overall Cardiovascular Study)
Timepoint [77] 0 0
Baseline and Month 24
Secondary outcome [78] 0 0
Change From Baseline in Serum Creatinine at Month 36 (Overall Cardiovascular Study)
Timepoint [78] 0 0
Baseline and Month 36
Secondary outcome [79] 0 0
Change From Baseline in Serum Creatinine at Month 48 (Overall Cardiovascular Study)
Timepoint [79] 0 0
Baseline and Month 48
Secondary outcome [80] 0 0
Change From Baseline in Serum Creatinine at Month 60 (Overall Cardiovascular Study)
Timepoint [80] 0 0
Baseline and Month 60
Secondary outcome [81] 0 0
Change From Baseline in Serum Creatinine at Month 72 (Overall Cardiovascular Study)
Timepoint [81] 0 0
Baseline and Month 72
Secondary outcome [82] 0 0
Baseline Urinary Albumin/Creatinine Ratio (Overall Cardiovascular Study)
Timepoint [82] 0 0
Baseline
Secondary outcome [83] 0 0
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 18 (Overall Cardiovascular Study)
Timepoint [83] 0 0
Baseline and Week 18
Secondary outcome [84] 0 0
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 52 (Overall Cardiovascular Study)
Timepoint [84] 0 0
Baseline and Week 52
Secondary outcome [85] 0 0
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 24 (Overall Cardiovascular Study)
Timepoint [85] 0 0
Baseline and Month 24
Secondary outcome [86] 0 0
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 36 (Overall Cardiovascular Study)
Timepoint [86] 0 0
Baseline and Month 36
Secondary outcome [87] 0 0
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 48 (Overall Cardiovascular Study)
Timepoint [87] 0 0
Baseline and Month 48
Secondary outcome [88] 0 0
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 60 (Overall Cardiovascular Study)
Timepoint [88] 0 0
Baseline and Month 60
Secondary outcome [89] 0 0
Percentage of Participants With Albuminuria Progression or Regression at Week 18 (Overall Cardiovascular Study)
Timepoint [89] 0 0
Week 18
Secondary outcome [90] 0 0
Percentage of Participants With Albuminuria Progression or Regression at Week 52 (Overall Cardiovascular Study)
Timepoint [90] 0 0
Week 52
Secondary outcome [91] 0 0
Percentage of Participants With Albuminuria Progression or Regression at Month 24 (Overall Cardiovascular Study)
Timepoint [91] 0 0
Month 24
Secondary outcome [92] 0 0
Percentage of Participants With Albuminuria Progression or Regression at Month 36 (Overall Cardiovascular Study)
Timepoint [92] 0 0
Month 36
Secondary outcome [93] 0 0
Percentage of Participants With Albuminuria Progression or Regression at Month 48 (Overall Cardiovascular Study)
Timepoint [93] 0 0
Month 48
Secondary outcome [94] 0 0
Percentage of Participants With Albuminuria Progression or Regression at Month 60 (Overall Cardiovascular Study)
Timepoint [94] 0 0
Month 60
Secondary outcome [95] 0 0
Percentage of Participants Experiencing an Adverse Event (AE) (Overall Cardiovascular Study)
Timepoint [95] 0 0
Up to approximately 6 years
Secondary outcome [96] 0 0
Percentage of Participants Experiencing an Adverse Event (AE) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
Timepoint [96] 0 0
Up to 18 weeks
Secondary outcome [97] 0 0
Percentage of Participants Experiencing an Adverse Event (AE) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
Timepoint [97] 0 0
Up to 18 weeks
Secondary outcome [98] 0 0
Percentage of Participants Experiencing an Adverse Event (AE) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
Timepoint [98] 0 0
Up to 18 weeks
Secondary outcome [99] 0 0
Percentage of Participants Discontinuing Study Treatment Due to An AE (Overall Cardiovascular Study)
Timepoint [99] 0 0
Up to approximately 6 years
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)
Timepoint [100] 0 0
Up to 18 weeks
Secondary outcome [101] 0 0
Percentage of Participants Discontinuing Study Treatment Due to An AE (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
Timepoint [101] 0 0
Up to 18 weeks
Secondary outcome [102] 0 0
Percentage of Participants Discontinuing Study Treatment Due to An AE (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
Timepoint [102] 0 0
Up to 18 weeks
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)
Timepoint [103] 0 0
Baseline and Week 18
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)
Timepoint [104] 0 0
Baseline and Week 18
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)
Timepoint [105] 0 0
Week 18
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)
Timepoint [106] 0 0
Baseline and Week 18
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)
Timepoint [107] 0 0
Baseline and Week 18
Secondary outcome [108] 0 0
Baseline Insulin Dose for Participants Receiving Insulin at Baseline - (Insulin With or Without Metformin Add-on Glycemic Sub-study)
Timepoint [108] 0 0
Baseline
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)
Timepoint [109] 0 0
Baseline and Week 18
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)
Timepoint [110] 0 0
Baseline and Week 18
Secondary outcome [111] 0 0
Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
Timepoint [111] 0 0
Baseline and Week 18
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)
Timepoint [112] 0 0
Week 18
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)
Timepoint [113] 0 0
Baseline and Week 18
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)
Timepoint [114] 0 0
Baseline and Week 18
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)
Timepoint [115] 0 0
Baseline and Week 18
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)
Timepoint [116] 0 0
Baseline and Week 18
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)
Timepoint [117] 0 0
Week 18
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)
Timepoint [118] 0 0
Baseline and Week 18
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)
Timepoint [119] 0 0
Baseline and Week 18

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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/12/2019
Sample size
Target
Accrual to date
Final
8246
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01986881