Phase 3
Completed N=8,246
Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004)
Source: ClinicalTrials.gov NCT01986881 ↗Enrolled (actual)
8,246
Serious AEs
30.8%
Results posted
Feb 2021
Primary outcomePrimary: 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) — 3.64; 4.16; 4.01; 3.90 Events per 100 Person-years — p=<0.001
◆ Published Evidence
Established
44citations · ~11 / year
Mediators of ertugliflozin effects on heart failure and kidney outcomes among patients with type 2 diabetes mellitus.
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.
Linked Publications (5)
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Mediators of ertugliflozin effects on heart failure and kidney outcomes among patients with type 2 diabetes mellitus.
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Cardiorenal outcomes, kidney function, and other safety outcomes with ertugliflozin in older adults with type 2 diabetes (VERTIS CV): secondary analyses from a randomised, double-blind trial.
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Ertugliflozin and incident obstructive sleep apnea: an analysis from the VERTIS CV trial.
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Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes.
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Initial eGFR Changes with Ertugliflozin and Associations with Clinical Parameters: Analyses from the VERTIS CV Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
3.64; 4.16; 4.01; 3.90 | <0.001 sig |
| PRIMARY Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study) |
8.45; 8.38; 8.39 | — |
| PRIMARY Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study) |
-0.77; -0.84; -0.19 | <0.001 sig |
| PRIMARY Baseline Hemoglobin A1C (A1C) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) |
8.27; 8.39; 8.21 | — |
| PRIMARY Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) |
-0.91; -0.78; -0.56 | 0.247 |
| PRIMARY Baseline Hemoglobin A1C (A1C) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) |
8.39; 8.30; 8.27 | — |
| PRIMARY Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Metformin With Sulfonylurea Add-on Glycemic Sub-study) |
-0.89; -0.98; -0.23 | <0.001 sig |
| SECONDARY Time to Occurrence of Cardiovascular (CV) Death or Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study) |
2.36; 2.33; 2.66; 2.34 | 0.108 |
| SECONDARY Time to Occurrence of Cardiovascular Death (On-study Approach) (Overall Cardiovascular Study) |
1.77; 1.74; 1.90; 1.76 | 0.385 |
| SECONDARY 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) |
0.87; 0.98; 1.15; 0.93 | 0.081 |
| SECONDARY 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) |
4.42; 4.67; 4.92; 4.54 | 0.183 |
| SECONDARY Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction (On-Study Approach) (Overall Cardiovascular Study) |
1.55; 2.00; 1.70; 1.77 | 0.676 |
| SECONDARY Time to First Occurrence of Fatal or Non-fatal Stroke (FNF Stroke) (On-Study Approach) (Overall Cardiovascular Study) |
0.92; 1.04; 0.93; 0.98 | 0.663 |
| SECONDARY Time to First Occurrence of Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study) |
0.75; 0.72; 1.05; 0.73 | 0.006 sig |
| SECONDARY Time to Occurrence of Death From Any Cause (On-Study Approach) (Overall Cardiovascular Study) |
2.42; 2.46; 2.62; 2.44 | 0.340 |
| SECONDARY Andersen-Gill Model for Total MACE (On-Study Approach) (Overall Cardiovascular Study) |
4.35; 4.91; 4.59; 4.63 | — |
| SECONDARY Andersen-Gill Model for All Cardiovascular Death (CV Death) or Hospitalizations for Heart Failure (HFF) (On-Study Approach) (Overall Cardiovascular Study) |
2.92; 2.71; 3.42; 2.82 | — |
| SECONDARY Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Overall Cardiovascular Study) |
-0.70; -0.72; -0.22 | <0.001 sig |
| SECONDARY Change From Baseline in A1C at Week 52 (Overall Cardiovascular Study) |
-0.69; -0.67; -0.19 | <0.001 sig |
| SECONDARY Change From Baseline in A1C at Month 24 (Overall Cardiovascular Study) |
-0.48; -0.46; -0.08 | <0.001 sig |
| SECONDARY Change From Baseline in A1C at Month 36 (Overall Cardiovascular Study) |
-0.42; -0.38; -0.04 | — |
| SECONDARY Change From Baseline in A1C at Month 48 (Overall Cardiovascular Study) |
-0.22; -0.17; 0.14 | 0.001 sig |
| SECONDARY Change From Baseline in A1C at Month 60 (Overall Cardiovascular Study) |
-0.25; -0.28; -0.10 | — |
| SECONDARY Change From Baseline in A1C at Month 72 (Overall Cardiovascular Study) |
-0.35; -0.13; 0.24 | — |
| SECONDARY Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Overall Cardiovascular Study) |
28.4; 28.2; 15.5 | — |
| SECONDARY Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 52 (Overall Cardiovascular Study) |
28.3; 29.0; 17.4 | — |
| SECONDARY Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 24 (Overall Cardiovascular Study) |
23.9; 23.8; 16.6 | — |
| SECONDARY Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 36 (Overall Cardiovascular Study) |
23.1; 22.7; 16.9 | — |
| SECONDARY Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 48 (Overall Cardiovascular Study) |
24.9; 22.7; 18.2 | — |
| SECONDARY Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 60 (Overall Cardiovascular Study) |
18.6; 20.0; 16.5 | — |
| SECONDARY Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 18 (Overall Cardiovascular Study) |
9.0; 8.8; 4.7 | — |
| SECONDARY Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 52 (Overall Cardiovascular Study) |
9.4; 10.9; 6.1 | — |
| SECONDARY Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 24 (Overall Cardiovascular Study) |
9.2; 8.6; 5.8 | — |
| SECONDARY Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 36 (Overall Cardiovascular Study) |
7.9; 8.0; 5.8 | — |
| SECONDARY Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 48 (Overall Cardiovascular Study) |
8.1; 9.1; 7.5 | — |
| SECONDARY Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 60 (Overall Cardiovascular Study) |
5.3; 9.5; 6.5 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) |
-32.18; -34.64; -17.08 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Overall Cardiovascular Study) |
-28.63; -28.97; -8.76 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Month 24 (Overall Cardiovascular Study) |
-22.09; -24.31; -4.39 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Month 36 (Overall Cardiovascular Study) |
-19.39; -22.59; -3.63 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Month 48 (Overall Cardiovascular Study) |
-15.28; -16.16; 3.59 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Month 60 (Overall Cardiovascular Study) |
-13.87; -11.15; -4.69 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Month 72 (Overall Cardiovascular Study) |
-2.46; -84.83; 14.56 | — |
| SECONDARY Time to the First Occurrence of a Participant Receiving Glycemic Rescue Therapy Through Week 18 (Overall Cardiovascular Study) |
59.0; 51.0; 74.0 | <0.001 sig |
| SECONDARY Time to Initiation of Insulin for Participants Not on Insulin at Baseline (Overall Cardiovascular Study) |
602; 650; 482 | <0.001 sig |
| SECONDARY Baseline Insulin Dose for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) |
63.82; 62.15; 65.74 | — |
| SECONDARY Change From Baseline in Insulin Dose at Week 18 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) |
1.05; 0.81; 3.71 | — |
| SECONDARY Change From Baseline in Insulin Dose at Week 52 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) |
0.84; -1.69; 5.57 | — |
| SECONDARY Change From Baseline in Insulin Dose at Month 24 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) |
0.45; -1.58; 6.16 | — |
| SECONDARY Change From Baseline in Insulin Dose at Month 36 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) |
1.64; -1.92; 7.99 | — |
| SECONDARY Change From Baseline in Insulin Dose at Month 48 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) |
2.96; -1.87; 7.28 | — |
| SECONDARY Change From Baseline in Insulin Dose at Month 60 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) |
-2.47; -1.77; 9.42 | — |
| SECONDARY Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) |
-2.51; -2.75; 0.03 | <0.001 sig |
| SECONDARY Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 (Overall Cardiovascular Study) |
-1.84; -2.41; 0.75 | <0.001 sig |
| SECONDARY Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 24 (Overall Cardiovascular Study) |
-1.80; -1.82; 0.90 | <0.001 sig |
| SECONDARY Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 36 (Overall Cardiovascular Study) |
-1.55; -1.21; 0.84 | — |
| SECONDARY Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 48 (Overall Cardiovascular Study) |
-2.07; -2.26; 0.53 | <0.001 sig |
| SECONDARY Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 60 (Overall Cardiovascular Study) |
-2.18; -1.87; 0.62 | — |
| SECONDARY Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 72 (Overall Cardiovascular Study) |
1.28; -3.46; 2.72 | — |
| SECONDARY Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) |
-0.99; -1.08; -0.12 | <0.001 sig |
| SECONDARY Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 52 (Overall Cardiovascular Study) |
-0.97; -0.95; -0.15 | <0.001 sig |
| SECONDARY Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 24 (Overall Cardiovascular Study) |
-0.94; -0.90; -0.23 | 0.010 sig |
| SECONDARY Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 36 (Overall Cardiovascular Study) |
-1.27; -0.92; -0.22 | — |
| SECONDARY Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 48 (Overall Cardiovascular Study) |
-1.45; -1.42; -0.64 | 0.024 sig |
| SECONDARY Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 60 (Overall Cardiovascular Study) |
-1.82; -1.43; -1.26 | — |
| SECONDARY Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 72 (Overall Cardiovascular Study) |
-2.18; 1.86; 7.29 | — |
| SECONDARY Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) |
-2.03; -2.32; -0.40 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight at Week 52 (Overall Cardiovascular Study) |
-2.46; -2.84; -0.39 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight at Month 24 (Overall Cardiovascular Study) |
-2.75; -3.17; -0.65 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight at Month 36 (Overall Cardiovascular Study) |
-3.03; -3.41; -0.98 | — |
| SECONDARY Change From Baseline in Body Weight at Month 48 (Overall Cardiovascular Study) |
-3.39; -3.83; -1.29 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight at Month 60 (Overall Cardiovascular Study) |
-3.66; -4.58; -1.21 | — |
| SECONDARY Change From Baseline in Body Weight at Month 72 (Overall Cardiovascular Study) |
-4.18; -7.37; -0.98 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 18 (Overall Cardiovascular Study) |
-1.22; -1.81; -0.03 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 (Overall Cardiovascular Study) |
-0.51; -1.18; -0.30 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 24 (Overall Cardiovascular Study) |
-1.48; -2.35; -2.60 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 36 (Overall Cardiovascular Study) |
-2.4; -2.3; -3.8 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 48 (Overall Cardiovascular Study) |
-2.75; -2.93; -4.41 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 60 (Overall Cardiovascular Study) |
-2.4; -2.9; -6.8 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 72 (Overall Cardiovascular Study) |
3.7; 0.2; -1.8 | — |
| SECONDARY Baseline Serum Creatinine (Overall Cardiovascular Study) |
0.992; 0.985; 0.991; 0.998 | — |
| SECONDARY Change From Baseline in Serum Creatinine at Week 18 (Overall Cardiovascular Study) |
0.022; 0.032; -0.002 | — |
| SECONDARY Change From Baseline in Serum Creatinine at Week 52 (Overall Cardiovascular Study) |
0.013; 0.023; 0.004 | — |
| SECONDARY Change From Baseline in Serum Creatinine at Month 24 (Overall Cardiovascular Study) |
0.024; 0.035; 0.034 | — |
| SECONDARY Change From Baseline in Serum Creatinine at Month 36 (Overall Cardiovascular Study) |
0.037; 0.035; 0.049 | — |
| SECONDARY Change From Baseline in Serum Creatinine at Month 48 (Overall Cardiovascular Study) |
0.032; 0.036; 0.059 | — |
| SECONDARY Change From Baseline in Serum Creatinine at Month 60 (Overall Cardiovascular Study) |
0.027; 0.042; 0.098 | — |
| SECONDARY Change From Baseline in Serum Creatinine at Month 72 (Overall Cardiovascular Study) |
-0.034; 0.001; -0.013 | — |
| SECONDARY Baseline Urinary Albumin/Creatinine Ratio (Overall Cardiovascular Study) |
18.00; 19.00; 19.00 | — |
| SECONDARY Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 18 (Overall Cardiovascular Study) |
-13.40; -14.71; 0.00 | — |
| SECONDARY Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 52 (Overall Cardiovascular Study) |
-2.53; -6.82; 5.41 | — |
| SECONDARY Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 24 (Overall Cardiovascular Study) |
-0.73; 1.06; 17.14 | — |
| SECONDARY Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 36 (Overall Cardiovascular Study) |
13.33; 3.33; 27.03 | — |
| SECONDARY Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 48 (Overall Cardiovascular Study) |
33.33; 21.25; 50.00 | — |
| SECONDARY Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 60 (Overall Cardiovascular Study) |
30.99; 20.00; 48.53 | — |
| SECONDARY Percentage of Participants With Albuminuria Progression or Regression at Week 18 (Overall Cardiovascular Study) |
7.6; 7.7; 10.8; 14.9; 14.7; 10.7 | — |
| SECONDARY Percentage of Participants With Albuminuria Progression or Regression at Week 52 (Overall Cardiovascular Study) |
9.5; 10.2; 12.9; 14.6; 14.8; 10.2 | — |
| SECONDARY Percentage of Participants With Albuminuria Progression or Regression at Month 24 (Overall Cardiovascular Study) |
12.1; 11.0; 16.9; 14.3; 13.8; 9.9 | — |
| SECONDARY Percentage of Participants With Albuminuria Progression or Regression at Month 36 (Overall Cardiovascular Study) |
14.6; 12.5; 18.1; 13.8; 14.3; 11.0 | — |
| SECONDARY Percentage of Participants With Albuminuria Progression or Regression at Month 48 (Overall Cardiovascular Study) |
19.5; 14.9; 21.5; 11.6; 12.2; 9.9 | — |
| SECONDARY Percentage of Participants With Albuminuria Progression or Regression at Month 60 (Overall Cardiovascular Study) |
18.6; 14.7; 22.1; 11.3; 14.8; 10.5 | — |
| SECONDARY Percentage of Participants Experiencing an Adverse Event (AE) (Overall Cardiovascular Study) |
85.8; 84.6; 85.6 | — |
| SECONDARY Percentage of Participants Experiencing an Adverse Event (AE) (Insulin With or Without Metformin Add-on Glycemic Sub-study) |
59.2; 62.4; 61.1 | — |
| SECONDARY Percentage of Participants Experiencing an Adverse Event (AE) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) |
47.3; 25.9; 45.8 | — |
| SECONDARY Percentage of Participants Experiencing an Adverse Event (AE) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) |
48.0; 54.9; 47.0 | — |
| SECONDARY Percentage of Participants Discontinuing Study Treatment Due to An AE (Overall Cardiovascular Study) |
7.5; 7.3; 6.8 | — |
| SECONDARY Percentage of Participants Discontinuing Study Treatment Due to An AE (Insulin With or Without Metformin Add-on Glycemic Sub-study) |
2.9; 3.8; 3.7 | — |
| SECONDARY Percentage of Participants Discontinuing Study Treatment Due to An AE (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) |
3.6; 1.9; 2.1 | — |
| SECONDARY Percentage of Participants Discontinuing Study Treatment Due to An AE (Metformin With Sulfonylurea Add-on Glycemic Sub-study) |
0; 2.7; 1.7 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) |
-26.98; -33.15; -7.74 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) |
-1.87; -2.13; -0.25 | <0.001 sig |
| SECONDARY 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) |
20.7; 21.1; 10.7 | <0.001 sig |
| SECONDARY 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) |
-2.67; -2.12; 0.20 | 0.025 sig |
| SECONDARY 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) |
-0.86; -0.64; -0.26 | 0.533 |
| SECONDARY Baseline Insulin Dose for Participants Receiving Insulin at Baseline - (Insulin With or Without Metformin Add-on Glycemic Sub-study) |
70.76; 67.29; 73.20 | — |
| SECONDARY 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) |
-0.71; -2.14; -0.29 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) |
-28.28; -26.97; -14.76 | 0.105 |
| SECONDARY Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) |
-1.75; -1.20; -0.68 | 0.418 |
| SECONDARY Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) |
32.7; 27.8; 25.0 | 0.460 |
| SECONDARY Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) |
-0.72; -0.80; -3.53 | 0.255 |
| SECONDARY Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) |
-1.18; -0.93; -2.91 | 0.178 |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) |
-35.28; -36.18; -4.81 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) |
-2.04; -2.41; -0.47 | <0.001 sig |
| SECONDARY Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) |
37.0; 32.7; 12.8 | <0.001 sig |
| SECONDARY Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) |
-2.26; -1.54; -0.70 | 0.597 |
| SECONDARY Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) |
-0.30; -0.92; -0.24 | 0.490 |
Eligibility 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
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:
- 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.
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01986881) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.