A Multicenter, Randomized, Double-Blind Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,306
- 试验地点
- 47
- 主要终点
- Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
研究概览
简要总结
The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone
详细描述
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive pioglitazone (rescue medication) added onto their blinded study medication
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
- 18 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Inadequate blood sugar control
- •No current treatment with other medications to lower blood sugar
排除标准
- •Major heart, liver or kidney problems
- •Pregnant or breast feeding
研究组 & 干预措施
Saxagliptin and Metformin (A)
PLUS open-label pioglitazone (as needed as rescue medication)
干预措施: Saxagliptin (Drug)
Saxagliptin and Metformin (A)
PLUS open-label pioglitazone (as needed as rescue medication)
干预措施: Metformin (Drug)
Saxagliptin and Metformin (A)
PLUS open-label pioglitazone (as needed as rescue medication)
干预措施: pioglitazone (Drug)
Saxagliptin and Metformin (B)
PLUS open-label pioglitazone (as needed as rescue medication)
干预措施: Saxagliptin (Drug)
Saxagliptin and Metformin (B)
PLUS open-label pioglitazone (as needed as rescue medication)
干预措施: Metformin (Drug)
Saxagliptin and Metformin (B)
PLUS open-label pioglitazone (as needed as rescue medication)
干预措施: pioglitazone (Drug)
Saxagliptin and Placebo (C)
PLUS open-label pioglitazone (as needed as rescue medication)
干预措施: Saxagliptin (Drug)
Saxagliptin and Placebo (C)
PLUS open-label pioglitazone (as needed as rescue medication)
干预措施: Placebo (Drug)
Saxagliptin and Placebo (C)
PLUS open-label pioglitazone (as needed as rescue medication)
干预措施: pioglitazone (Drug)
Metformin and Placebo (D)
PLUS open-label pioglitazone (as needed as rescue medication)
干预措施: Metformin (Drug)
Metformin and Placebo (D)
PLUS open-label pioglitazone (as needed as rescue medication)
干预措施: Placebo (Drug)
Metformin and Placebo (D)
PLUS open-label pioglitazone (as needed as rescue medication)
干预措施: pioglitazone (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
时间窗: Baseline, Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy
时间窗: Baseline, Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy(Baseline, Week 24)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy(Baseline, Week 24)
- Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy(Week 24)
- Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy(Week 24)
- Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy(Baseline, Week 24)
- Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy(Baseline, Week 24)
- Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy(Week 24)
- Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy(Week 24)
- Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy(Week 24)
- Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy(Week 24)