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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8,246
- 主要终点
- Baseline Hemoglobin A1C (A1C) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
研究概览
简要总结
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.
详细描述
The primary hypotheses for the 4 studies are:
- Overall Cardiovascular Study:
The time to first occurrence of the composite endpoint of MACE: cardiovascular death, non-fatal myocardial infarction [MI] or non-fatal stroke in participants treated with ertugliflozin is non-inferior compared to that in participants treated with placebo. 2. The 3 Glycemic Sub-studies:
- The mean reduction from baseline in hemoglobin A1c (A1C) for 15 mg ertugliflozin is greater than that for placebo.
- The mean reduction from baseline in A1C for 5 mg ertugliflozin is greater than that for placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ertugliflozin, 15 mg
Ertugliflozin 15 mg administered orally once daily for up to approximately 6 years
干预措施: Ertugliflozin (Drug)
Ertugliflozin, 15 mg
Ertugliflozin 15 mg administered orally once daily for up to approximately 6 years
干预措施: Glycemic Rescue (Drug)
Ertugliflozin, 5 mg
Ertugliflozin 5 mg administered orally once daily for up to approximately 6 years
干预措施: Ertugliflozin (Drug)
Ertugliflozin, 5 mg
Ertugliflozin 5 mg administered orally once daily for up to approximately 6 years
干预措施: Placebo (Drug)
Ertugliflozin, 5 mg
Ertugliflozin 5 mg administered orally once daily for up to approximately 6 years
干预措施: Glycemic Rescue (Drug)
Placebo
Matching placebo to ertugliflozin administered orally once daily for up to approximately 6 years
干预措施: Placebo (Drug)
Placebo
Matching placebo to ertugliflozin administered orally once daily for up to approximately 6 years
干预措施: Glycemic Rescue (Drug)
结局指标
主要结局
Baseline Hemoglobin A1C (A1C) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
时间窗: Baseline
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.
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)
时间窗: Up to approximately 6 years
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).
Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
时间窗: Baseline
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.
Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study)
时间窗: Baseline and Week 18
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.
Baseline Hemoglobin A1C (A1C) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
时间窗: Baseline
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.
Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
时间窗: Baseline and Week 18
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.
Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
时间窗: Baseline and Week 18
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.
次要结局
- Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 18 (Overall Cardiovascular Study)(Week 18)
- Change From Baseline in Insulin Dose at Month 36 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)(Baseline and Month 36)
- Time to Occurrence of Cardiovascular (CV) Death or Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study)(Up to approximately 6 years)
- Time to Occurrence of Cardiovascular Death (On-study Approach) (Overall Cardiovascular Study)(Up to approximately 6 years)
- 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)(Up to approximately 6 years)
- 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)(Up to approximately 6 years)
- Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction (On-Study Approach) (Overall Cardiovascular Study)(Up to approximately 6 years)
- Time to First Occurrence of Fatal or Non-fatal Stroke (FNF Stroke) (On-Study Approach) (Overall Cardiovascular Study)(Up to approximately 6 years)
- Time to First Occurrence of Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study)(Up to approximately 6 years)
- Time to Occurrence of Death From Any Cause (On-Study Approach) (Overall Cardiovascular Study)(Up to approximately 6 years)
- Andersen-Gill Model for Total MACE (On-Study Approach) (Overall Cardiovascular Study)(Up to approximately 6 years)
- Andersen-Gill Model for All Cardiovascular Death (CV Death) or Hospitalizations for Heart Failure (HFF) (On-Study Approach) (Overall Cardiovascular Study)(Up to approximately 6 years)
- Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 52 (Overall Cardiovascular Study)(Week 52)
- Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Overall Cardiovascular Study)(Baseline and Week 18)
- Change From Baseline in A1C at Week 52 (Overall Cardiovascular Study)(Baseline and Week 52)
- Change From Baseline in A1C at Month 24 (Overall Cardiovascular Study)(Baseline and Month 24)
- Change From Baseline in A1C at Month 36 (Overall Cardiovascular Study)(Baseline and Month 36)
- Change From Baseline in A1C at Month 48 (Overall Cardiovascular Study)(Baseline and Month 48)
- Change From Baseline in A1C at Month 60 (Overall Cardiovascular Study)(Baseline and Month 60)
- Change From Baseline in A1C at Month 72 (Overall Cardiovascular Study)(Baseline and Month 72)
- Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Overall Cardiovascular Study)(Week 18)
- Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 52 (Overall Cardiovascular Study)(Week 52)
- Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 24 (Overall Cardiovascular Study)(Month 24)
- Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 36 (Overall Cardiovascular Study)(Month 36)
- Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 48 (Overall Cardiovascular Study)(Month 48)
- Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 60 (Overall Cardiovascular Study)(Month 60)
- Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 24 (Overall Cardiovascular Study)(Month 24)
- Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 36 (Overall Cardiovascular Study)(Month 36)
- Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 48 (Overall Cardiovascular Study)(Month 48)
- Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 60 (Overall Cardiovascular Study)(Month 60)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)(Baseline and Week 18)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Overall Cardiovascular Study)(Baseline and Week 52)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Month 24 (Overall Cardiovascular Study)(Baseline and Month 24)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Month 36 (Overall Cardiovascular Study)(Baseline and Month 36)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Month 48 (Overall Cardiovascular Study)(Baseline and Month 48)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Month 60 (Overall Cardiovascular Study)(Baseline and Month 60)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 (Overall Cardiovascular Study)(Baseline and Week 52)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Month 72 (Overall Cardiovascular Study)(Baseline and Month 72)
- Time to the First Occurrence of a Participant Receiving Glycemic Rescue Therapy Through Week 18 (Overall Cardiovascular Study)(Up to 18 weeks)
- Time to Initiation of Insulin for Participants Not on Insulin at Baseline (Overall Cardiovascular Study)(Up to approximately 6 years)
- Baseline Insulin Dose for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)(Baseline)
- Change From Baseline in Insulin Dose at Week 18 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)(Baseline and Week 18)
- Change From Baseline in Insulin Dose at Week 52 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)(Baseline and Week 52)
- Change From Baseline in Insulin Dose at Month 24 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)(Baseline and Month 24)
- Change From Baseline in Insulin Dose at Month 48 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)(Baseline and Month 48)
- Change From Baseline in Insulin Dose at Month 60 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)(Baseline and Month 60)
- Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)(Baseline and Week 18)
- Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 (Overall Cardiovascular Study)(Baseline and Week 52)
- Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 24 (Overall Cardiovascular Study)(Baseline and Month 24)
- Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 36 (Overall Cardiovascular Study)(Baseline and Month 36)
- Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 48 (Overall Cardiovascular Study)(Baseline and Month 48)
- Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 60 (Overall Cardiovascular Study)(Baseline and Month 60)
- Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 72 (Overall Cardiovascular Study)(Baseline and Month 72)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 24 (Overall Cardiovascular Study)(Baseline and Month 24)
- Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)(Baseline and Week 18)
- Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 52 (Overall Cardiovascular Study)(Baseline and Week 52)
- Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 24 (Overall Cardiovascular Study)(Baseline and Month 24)
- Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 36 (Overall Cardiovascular Study)(Baseline and Month 36)
- Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 48 (Overall Cardiovascular Study)(Baseline and Month 48)
- Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 60 (Overall Cardiovascular Study)(Baseline and Month 60)
- Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 72 (Overall Cardiovascular Study)(Baseline and Month 72)
- Change From Baseline in Serum Creatinine at Month 48 (Overall Cardiovascular Study)(Baseline and Month 48)
- Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)(Baseline and Week 18)
- Change From Baseline in Body Weight at Week 52 (Overall Cardiovascular Study)(Baseline and Week 52)
- Change From Baseline in Body Weight at Month 24 (Overall Cardiovascular Study)(Baseline and Month 24)
- Change From Baseline in Body Weight at Month 36 (Overall Cardiovascular Study)(Baseline and Month 36)
- Change From Baseline in Body Weight at Month 48 (Overall Cardiovascular Study)(Baseline and Month 48)
- Change From Baseline in Body Weight at Month 60 (Overall Cardiovascular Study)(Baseline and Month 60)
- Change From Baseline in Body Weight at Month 72 (Overall Cardiovascular Study)(Baseline and Month 72)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 18 (Overall Cardiovascular Study)(Baseline and Week 18)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 36 (Overall Cardiovascular Study)(Baseline and Month 36)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 48 (Overall Cardiovascular Study)(Baseline and Month 48)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 60 (Overall Cardiovascular Study)(Baseline and Month 60)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 72 (Overall Cardiovascular Study)(Baseline and Month 72)
- Baseline Serum Creatinine (Overall Cardiovascular Study)(Baseline)
- Change From Baseline in Serum Creatinine at Week 18 (Overall Cardiovascular Study)(Baseline and Week 18)
- Change From Baseline in Serum Creatinine at Week 52 (Overall Cardiovascular Study)(Baseline and Week 52)
- Change From Baseline in Serum Creatinine at Month 24 (Overall Cardiovascular Study)(Baseline and Month 24)
- Change From Baseline in Serum Creatinine at Month 36 (Overall Cardiovascular Study)(Baseline and Month 36)
- Change From Baseline in Serum Creatinine at Month 60 (Overall Cardiovascular Study)(Baseline and Month 60)
- Change From Baseline in Serum Creatinine at Month 72 (Overall Cardiovascular Study)(Baseline and Month 72)
- Baseline Urinary Albumin/Creatinine Ratio (Overall Cardiovascular Study)(Baseline)
- Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 18 (Overall Cardiovascular Study)(Baseline and Week 18)
- Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 52 (Overall Cardiovascular Study)(Baseline and Week 52)
- Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 24 (Overall Cardiovascular Study)(Baseline and Month 24)
- Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 36 (Overall Cardiovascular Study)(Baseline and Month 36)
- Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 48 (Overall Cardiovascular Study)(Baseline and Month 48)
- Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 60 (Overall Cardiovascular Study)(Baseline and Month 60)
- Percentage of Participants With Albuminuria Progression or Regression at Week 18 (Overall Cardiovascular Study)(Week 18)
- Percentage of Participants With Albuminuria Progression or Regression at Week 52 (Overall Cardiovascular Study)(Week 52)
- Percentage of Participants With Albuminuria Progression or Regression at Month 24 (Overall Cardiovascular Study)(Month 24)
- Percentage of Participants With Albuminuria Progression or Regression at Month 36 (Overall Cardiovascular Study)(Month 36)
- Percentage of Participants With Albuminuria Progression or Regression at Month 48 (Overall Cardiovascular Study)(Month 48)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)(Baseline and Week 18)
- Percentage of Participants With Albuminuria Progression or Regression at Month 60 (Overall Cardiovascular Study)(Month 60)
- Percentage of Participants Experiencing an Adverse Event (AE) (Overall Cardiovascular Study)(Up to approximately 6 years)
- Percentage of Participants Experiencing an Adverse Event (AE) (Insulin With or Without Metformin Add-on Glycemic Sub-study)(Up to 18 weeks)
- Percentage of Participants Experiencing an Adverse Event (AE) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)(Up to 18 weeks)
- Percentage of Participants Experiencing an Adverse Event (AE) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)(Up to 18 weeks)
- Percentage of Participants Discontinuing Study Treatment Due to An AE (Overall Cardiovascular Study)(Up to approximately 6 years)
- Percentage of Participants Discontinuing Study Treatment Due to An AE (Insulin With or Without Metformin Add-on Glycemic Sub-study)(Up to 18 weeks)
- Baseline Insulin Dose for Participants Receiving Insulin at Baseline - (Insulin With or Without Metformin Add-on Glycemic Sub-study)(Baseline)
- Percentage of Participants Discontinuing Study Treatment Due to An AE (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)(Up to 18 weeks)
- Percentage of Participants Discontinuing Study Treatment Due to An AE (Metformin With Sulfonylurea Add-on Glycemic Sub-study)(Up to 18 weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)(Baseline and Week 18)
- 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)(Baseline and Week 18)
- Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)(Baseline and Week 18)
- Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)(Week 18)
- Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)(Baseline and Week 18)
- Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)(Week 18)
- Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)(Baseline and Week 18)
- 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)(Week 18)
- 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)(Baseline and Week 18)
- 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)(Baseline and Week 18)
- Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)(Baseline and Week 18)
- Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)(Baseline and Week 18)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)(Baseline and Week 18)
- Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)(Baseline and Week 18)
- Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)(Baseline and Week 18)