A 4-Week, Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy of Saxagliptin in Combination With Metformin XR 1500 mg Versus Up-titrated Metformin XR to 2000 mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise and a Stable Dose of Metformin XR 1500 mg
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 219
- 试验地点
- 13
- 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
The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •18-78 years of age
- •Taking stable dose of metformin immediate release (IR) or XR ≥850 mg and ≤1500 mg as monotherapy for at least 8 weeks prior to screening
- •Glycosylated hemoglobin A1C (A1C) 7.5-11.5% at screening
- •Fasting C-peptide: ≥1.0 ng/mL
- •FPG≥126 mg/dl obtained at the Day -7 visit
- •Body mass index (BMI): ≤ 40kg/m²
- •A1C ≥ 7.0% and ≤ 11.0% obtained at the Day -7 visit for randomization
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 + Metformin XR + matching Metformin XR placebo
(Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo)
干预措施: Saxagliptin (Drug)
Saxagliptin + Metformin XR + matching Metformin XR placebo
(Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo)
干预措施: Metformin XR (Drug)
Saxagliptin + Metformin XR + matching Metformin XR placebo
(Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo)
干预措施: Placebo matching Metformin XR (Drug)
Metformin XR + Metformin XR + matching Saxagliptin placebo
(Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo)
干预措施: Metformin XR (Drug)
Metformin XR + Metformin XR + matching Saxagliptin placebo
(Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo)
干预措施: Placebo matching Saxagliptin (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 to Week 4 in 2-hour Postprandial Glucose (PPG) (2 Hours After the Evening Meal)(Baseline, Week 4)
- Change From Baseline Fasting Plasma Glucose (FPG) at Week 4, Obtained Immediately Before the Morning Meal(Baseline, Week 4)