NCT00162240已完成3 期
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Metformin Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Bristol-Myers Squibb198 个研究点 分布在 2 个国家目标入组 534 人开始时间: 2003年6月最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 534
- 试验地点
- 198
- 主要终点
- compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + metformin vs placebo + metformin
研究概览
简要总结
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Metformin Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy 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
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes
- •HbA1c > - 7.0% and < - 10.0 %
- •Mean serum triglyceride < - 600 mg/dL
- •Body mass index < - 41 kg/m2
- •Fasting c-peptide > - 1.0 ng/mL
排除标准
- •History of myocardial infarction (MI)
- •coronary angioplasty or bypass graft(s)
- •valvular disease or repair
- •unstable angina pectoris
- •transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months
- •Congestive heart failure NYHA Class III and IV
- •Uncontrolled hypertension
- •History of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease
结局指标
主要结局
compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + metformin vs placebo + metformin
次要结局
- change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in hs-CRP from baseline to W24
研究者
研究点 (198)
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