A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Triple Therapy With Saxagliptin Added to Dapagliflozin in Combination With Metformin Compared to Therapy With Placebo Added to Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin and Dapagliflozin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 315
- 试验地点
- 35
- 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-477118 (Saxagliptin) 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.
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
Arm 2: Placebo+Dapagliflozin+Metformin IR
干预措施: Metformin IR (Drug)
Arm 2: Placebo+Dapagliflozin+Metformin IR
干预措施: Placebo matching with Saxagliptin (Drug)
Arm 1: Saxagliptin+Dapagliflozin+Metformin IR
干预措施: Saxagliptin (Drug)
Arm 1: Saxagliptin+Dapagliflozin+Metformin IR
干预措施: Dapagliflozin (Drug)
Arm 1: Saxagliptin+Dapagliflozin+Metformin IR
干预措施: Metformin IR (Drug)
Arm 2: Placebo+Dapagliflozin+Metformin IR
干预措施: Dapagliflozin (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. 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 at Week 24 in the double-blind period, including observations prior to rescue.
次要结局
- Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24(From Baseline to Week 24)
- Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])(From Baseline to Week 24)
- Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24(From Baseline to Week 24)