NCT00885378已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, Twice Daily, in Combination With Metformin IR in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin IR Alone
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 166
- 试验地点
- 26
- 主要终点
- Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12
研究概览
简要总结
The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR 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 twice daily (BID) dosing of metformin IR (at least 1500 mg) for at least 8 weeks
- •A1C: 7-10%
- •C-peptide: ≥ 0.8 ng/mL
- •Body mass index (BMI): ≤45 kg/m^2
排除标准
- •Women of childbearing potential unable or unwilling to use acceptable birth control
- •Women who are pregnant or breastfeeding
- •Fasting plasma glucose (FPG) >270 mg/dL
- •Significant cardiovascular history
- •Symptoms of poorly controlled diabetes
- •History of diabetic ketoacidosis or hyperosmolar nonketotic coma
- •Insulin therapy within one year of screening
- •Cardiovascular even within the prior 6 months
- •New York Heart Association Stage III/IV congestive heart failure and/or known left ventricular ejection fraction <=40%
- •Significant history of renal or hepatic disease
- •History of a psychiatric disorder, alcohol or drug abuse within the previous year
- •Treatment with potent CYP3A4 inhibitors or inducers
- •Immunocompromised participants
- •Active liver disease or clinically significant abnormal hepatic, renal , endocrine, metabolic, or hematological screening tests
研究组 & 干预措施
Saxagliptin plus metformin IR
Active Comparator
干预措施: Saxagliptin plus metformin IR (Drug)
Placebo plus metformin IR
Placebo Comparator
干预措施: Placebo plus metformin IR (Drug)
结局指标
主要结局
Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12
时间窗: Baseline, Week 12
Mean change was adjusted for baseline.
次要结局
- Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG)(Baseline, Week 12)
- Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12(Week 12)
- Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12(Week 12)
研究者
研究点 (26)
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