CTRI/2010/091/000430已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
The pharmaceutical company sponsoring this study is BristolMyers SquibbAddress5 个研究点 分布在 1 个国家目标入组 444 人开始时间: 2011年2月28日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 444
- 试验地点
- 5
- 主要终点
- Change from baseline in HbA1c for each dose of dapagliflozin vs placebo
研究概览
简要总结
First subject of the study was screened at Chinese site on 17th June 2010. First subject from India is expected by 15th November 2010. There are approximately 50 subjects to be randomized from India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females, 18 to 65 years old, with type 2 diabetes and with inadequate glycemic control.
- •Drug naive or treated with anti-diabetic medication for < 24 weeks.
- •C-peptide ≥ 1.0 ng/mL.
- •Body Mass Index ≤ 45.0 kg/m².
排除标准
- •AST and/or ALT > 1.5 times ULN- Serum total bilirubin > 2 mg/dL- Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women- Creatine kinase ≥ 3 times ULN- Symptoms of severely uncontrolled diabetes-Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases.
结局指标
主要结局
Change from baseline in HbA1c for each dose of dapagliflozin vs placebo
时间窗: At week 24
次要结局
- Change from baseline in Fasting Plasma Glucose (FPG)(At week 24)
- Change from baseline in 2hr-post meal glucose(At week 24)
- Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%(At week 24)
- Change from baseline in total body weight(At week 24)
研究者
研究点 (5)
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