A 4-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial To Evaluate The Efficacy And Safety Of Saxagliptin In Comparison To Placebo As Add On Treatment To Metformin XR In Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet And Exercise And A Stable Dose Of Metformin ≥1500 mg/Day
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 93
- 试验地点
- 14
- 主要终点
- Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4
研究概览
简要总结
This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone
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
- •≥18- and ≤77-years-old
- •Type 2 diabetes
- •Taking metformin immediate release (IR) or XR ≥1500 mg for at least 8 weeks as monotherapy
- •Glycosylated hemoglobin (A1C) ≥7% and ≤10%
- •Body mass index (BMI) ≤40 kg/m2
排除标准
- •Women of childbearing potential unable or unwilling to use acceptable birth control
- •Women who are pregnant or breastfeeding
- •Significant cardiovascular history
- •Active liver disease
- •Renal impairment
研究组 & 干预措施
Saxagliptin 5 mg + Metformin
干预措施: Saxagliptin (Drug)
Placebo + Metformin
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4
时间窗: Baseline, Week 4
Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.
次要结局
- Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4(Baseline, Week 4)
- Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4(Baseline, Week 4)
- Change From Baseline in Mean Daily Glucose at Week 4(Baseline, Week 4)
- Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4(Baseline, Week 4)