NCT00106808已完成3 期
A Phase 3, Randomized, Double-blind, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Muraglitazar (BMS-298585) Compared to Pioglitazone in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Bristol-Myers Squibb194 个研究点 分布在 2 个国家目标入组 1,440 人开始时间: 2005年8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
- 1,440
- 试验地点
- 194
- 主要终点
- Change in HBA1c from baseline to Week 24
研究概览
简要总结
The purpose of this study is to compare Muraglitazar and Pioglitazone in patients with Type 2 Diabetes. Both the safety and blood sugar lowering effects of these treatments will 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
- 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 > = 8.0% and < = 12.0%
- •Serum triglyceride concentration < = 600 mg/dL
- •Fasting c-peptide > = 1.0 ng/ml
- •Body mass index < = 41 kg/m2
- •Drug naive patients
排除标准
- •History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular accidents, accelerated/malignant hypertension, or hypertension related CHF (congestive heart failure) within six months prior to screening and during the Lead-In Phase.
- •Women of child Bearing Potential
- •Uncontrolled hypertension, CHF defined as New York Heart Association (NYHA) Class II, III and IV, exacerbation of previously stable CHF (any NYHA class) or uncontrolled cardiac arrhythmia in the 30 days prior to screening and during the Lead-In Phase.
- •History of renal disease, bladder cancer, pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.
结局指标
主要结局
Change in HBA1c from baseline to Week 24
次要结局
- To assess safety and tolerability of both Muraglitazar regimens relative to pioglitazone regimen when administered for up to 24 weeks
- Change for baseline in TG and HDL-C at Week 24
- Change from baseline in FPG, fasting insulin, fasting c-peptide, body mass index, body weight, waist circumferance, SBP and DBP.
研究者
研究点 (194)
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