EUCTR2011-000656-42-FI进行中（未招募）不适用
A 66-Week Extension to: A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding, Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control. (Original Study EudraCT # 2010-022193-13)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 510
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Complete the double-blind base study (with or without initiation of glycemic rescue medication with open-label metformin).
- •2. Have ³75% compliance with double-blind study medication during the base study double-blind treatment period.
- •3. Understand the extension study procedures and agree to participate in the extension by giving written informed consent.
- •4. Women of childbearing potential must continue to comply with the protocol-specified contraceptive methods as previously outlined in the base study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Have any contraindication for the use of pioglitazone described in the package insert from the country of the investigational site.
- •2. Patient meets any of the base study criteria for discontinuation from the study drug.
研究者
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.A.Type 2 Diabetes MellitusEUCTR2011-000656-42-LTMerck Sharp & Dohme Corp.663
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未知
不适用
A 66-WEEK EXTENSION TO: A PHASE IIB, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGE FINDING CLINICAL TRIAL TO STUDY THE SAFETY AND EFFICACY OF MK-3102 IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND INADEQUATE GLYCEMIC CONTROPER-062-11MERCK SHARP & DOHME PERU S.R.L.,