A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Glyburide in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Glyburide Alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 768
- 试验地点
- 55
- 主要终点
- Change From Baseline in Hemoglobin A1c (A1C) at Week 24
研究概览
简要总结
The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes
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 (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.
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.
- •Treated with a sulfonylurea for at least 2 months.
- •Inadequate blood sugar control.
- •Are not on any other medications to lower blood sugar.
- •No major heart, liver or kidney problems.
- •Women not pregnant or breast feeding.
排除标准
- 未提供
研究组 & 干预措施
Saxagliptin 2.5 mg + Glyburide 7.5 mg (A)
Metformin 500-2500 mg (as needed)
干预措施: Saxagliptin (Drug)
Saxagliptin 2.5 mg + Glyburide 7.5 mg (A)
Metformin 500-2500 mg (as needed)
干预措施: Glyburide (Drug)
Saxagliptin 2.5 mg + Glyburide 7.5 mg (A)
Metformin 500-2500 mg (as needed)
干预措施: Metformin (Drug)
Saxagliptin 5 mg + Glyburide 7.5 mg (B)
Metformin 500-2500 mg (as needed)
干预措施: Saxagliptin (Drug)
Saxagliptin 5 mg + Glyburide 7.5 mg (B)
Metformin 500-2500 mg (as needed)
干预措施: Glyburide (Drug)
Saxagliptin 5 mg + Glyburide 7.5 mg (B)
Metformin 500-2500 mg (as needed)
干预措施: Metformin (Drug)
Placebo + Glyburide 7.5 mg (C)
Metformin 500-2500 mg (as needed)
干预措施: Placebo (Drug)
Placebo + Glyburide 7.5 mg (C)
Metformin 500-2500 mg (as needed)
干预措施: Glyburide (Drug)
Placebo + Glyburide 7.5 mg (C)
Metformin 500-2500 mg (as needed)
干预措施: Metformin (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
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(Baseline, Week 24)
- Percentage of Participants Achieving A1C < 7% at Week 24(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(Baseline, Week 24)