A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Therapy With Dapagliflozin Added to Saxagliptin in Combination With Metformin Compared to Therapy With Placebo Added to Saxagliptin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin and Saxagliptin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 320
- 试验地点
- 28
- 主要终点
- Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24
研究概览
简要总结
The purpose of this study is to learn if BMS-512148 (Dapagliflozin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.
详细描述
Prior to randomization, all eligible subjects will receive open-label treatment with Saxagliptin 5mg and Metformin IR during the 16-week open-label treatment period.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 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
Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR
干预措施: Dapagliflozin (Drug)
Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR
干预措施: Saxagliptin (Drug)
Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR
干预措施: Metformin immediate release (IR) (Drug)
Arm 2: Placebo + Saxagliptin + Metformin IR
干预措施: Placebo matching with Dapagliflozin (Drug)
Arm 2: Placebo + Saxagliptin + Metformin IR
干预措施: Saxagliptin (Drug)
Arm 2: Placebo + Saxagliptin + Metformin IR
干预措施: Metformin immediate release (IR) (Drug)
结局指标
主要结局
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24
时间窗: From Baseline to Week 24
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period.
次要结局
- Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24(From Baseline to Week 24)
- Adjusted Mean Change From Baseline in 120-minute Postprandial Glucose (PPG) at Week 24(From Baseline to Week 24)
- Adjusted Mean Change From Baseline in Body Weight at Week 24(From baseline to Week 24)
- Percentage of Subjects Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])(From baseline to week 24)