A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy With Saxagliptin and Dapagliflozin Added to Metformin Compared to Add-On Therapy With Saxagliptin in Combination With Metformin or Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,282
- 试验地点
- 73
- 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 a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. 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
- •Subjects with Type 2 diabetes mellitus (T2DM) with HbA1c ≥ 8.0% and ≤ 12.0%
- •Stable metformin therapy dose of ≥ 1500mg for at least 8 weeks prior to screening
- •Body mass index (BMI) ≤ 45.0kg/m2
排除标准
- •Estimated glomerular filtration rate (eGFR) < 60mL/min/1,73m2 and Serum Creatinine (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females
- •Uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 160mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100mmHg
- •Hepatic disease
- •Cardiovascular disease within 3 months
研究组 & 干预措施
Arm 2: Dapagliflozin+Metformin XR+Placebo
干预措施: Metformin XR (Drug)
Arm 1: Saxagliptin+Metformin XR+Placebo
干预措施: Saxagliptin (Drug)
Arm 1: Saxagliptin+Metformin XR+Placebo
干预措施: Metformin XR (Drug)
Arm 1: Saxagliptin+Metformin XR+Placebo
干预措施: Placebo matching with Dapagliflozin (Drug)
Arm 2: Dapagliflozin+Metformin XR+Placebo
干预措施: Dapagliflozin (Drug)
Arm 2: Dapagliflozin+Metformin XR+Placebo
干预措施: Placebo matching with Saxagliptin (Drug)
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR
干预措施: Saxagliptin (Drug)
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR
干预措施: Metformin XR (Drug)
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR
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: Baseline (Week 0) and at 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 Fasting Plasma Glucose (FPG) at Week 24(Baseline (Week 0) and at Week 24)
- Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])(At Week 24)
- Adjusted Mean Change From Baseline in Body Weight at Week 24(Baseline (Week 0) and at Week 24)
- Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24 (Last Observation Carried Forward [LOCF])(Baseline (Week 0) and at Week 24)