A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,035
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c (A1C) Changes From Baseline at Week 24
研究概览
简要总结
The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise
详细描述
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin added onto their blinded study medication. Subjects with screening hemoglobin A1c (A1C) > 10.0% and ≤ 12.0%, who otherwise meet all inclusion/exclusion criteria, were eligible to enroll directly into Open-Label Treatment Cohort (Direct Enrollees) and receive open-label saxagliptin 10 mg. Those who completed the short-term period were eligible to enter into the long-term treatment extension period.Saxagliptin dose titration was not permitted.
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
- •Type 2 diabetes mellitus
- •Drug naive
- •Hemoglobin (Hb) A1c >= 7.0% and <= 10.0% (>10% and <= 12% for open label arm)
- •Fasting C-peptide >= 1 ng/mL
- •Body mass index <= 40 kg/m2
排除标准
- •Symptomatic poorly controlled diabetes
- •Recent cardiac or cerebrovascular event
- •Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for Women of Child Bearing Potential
研究组 & 干预措施
Saxagliptin 2.5 mg (A)
Metformin 500-2000 mg (as needed for rescue)
干预措施: Saxagliptin (Drug)
Saxagliptin 2.5 mg (A)
Metformin 500-2000 mg (as needed for rescue)
干预措施: Placebo matching Metformin (Drug)
Saxagliptin 2.5 mg (A)
Metformin 500-2000 mg (as needed for rescue)
干预措施: Metformin (Drug)
Saxagliptin 5 mg (B)
Metformin 500-2000 mg (as needed for rescue)
干预措施: Saxagliptin (Drug)
Saxagliptin 5 mg (B)
Metformin 500-2000 mg (as needed for rescue)
干预措施: Placebo matching Metformin (Drug)
Saxagliptin 5 mg (B)
Metformin 500-2000 mg (as needed for rescue)
干预措施: Metformin (Drug)
Saxagliptin 10 mg (C)
Metformin 500-2000 mg (as needed for rescue)
干预措施: Saxagliptin (Drug)
Saxagliptin 10 mg (C)
Metformin 500-2000 mg (as needed for rescue)
干预措施: Placebo matching Metformin (Drug)
Saxagliptin 10 mg (C)
Metformin 500-2000 mg (as needed for rescue)
干预措施: Metformin (Drug)
Placebo (D)
Metformin 500-2000 mg (as needed for rescue)
干预措施: Placebo matching Saxagliptin (Drug)
Placebo (D)
Metformin 500-2000 mg (as needed for rescue)
干预措施: Metformin (Drug)
Open-Label Treatment Cohort (Direct Enrollees) (E)
Saxagliptin 10 mg
Metformin 500-2000 mg (as needed for rescue)
干预措施: Saxagliptin (Drug)
Open-Label Treatment Cohort (Direct Enrollees) (E)
Saxagliptin 10 mg
Metformin 500-2000 mg (as needed for rescue)
干预措施: Metformin (Drug)
结局指标
主要结局
Hemoglobin A1c (A1C) Changes From Baseline at Week 24
时间窗: Baseline, Week 24
To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.
A1C Changes From Baseline at Week 24 - Open Label Cohort
时间窗: Baseline, Week 24
To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.
次要结局
- Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)(Baseline, Week 24)
- Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24(Week 24)
- Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)(Baseline, Week 24)
- Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort(Baseline, Week 24)
- Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort(Week 24)
- Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort(Baseline, Week 24)