PER-048-13未知未知
A PHASE III, MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF SITAGLIPTIN IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS WITH INADEQUATE GLYCEMIC CONTROL ON METFORMI
Merck Sharp & Dohme Corp., una subsidiaria de Mer·ck & Co. Inc.,0 个研究点目标入组 0 人开始时间: 2013年11月12日最近更新:
试验速览
- 阶段
- 未知
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Have T2DM and be ≥18 years of age on the day of signing the informed consent form.
- •Be currently taking a stable dose of metformin (≥1500 mg/day) for ≥12 weeks and have an A1C ≥6.5% (48 mmol/mol) and ≤9.0% (75 mmol/mol).
- •Meet one of the following criteria:
- •a. Subject is a male.
- •b. Subject is a female not of reproductive potential or Subject is a female of reproductive potential and agrees to remain abstinent from heterosexual activity OR agrees to use (or have their partner use) acceptable contraception to prevent pregnancy within the projected duration of the trial and for 21 days after the last dose of blinded study medication.
- •Understand the trial procedures, alternative treatments available, and risks involved with the trial, and voluntarily agrees to participate by giving written informed consent. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
- •At Visit 3/Randomization/Day 1
- •Must be 100% compliant with MK-3102 placebo treatment and 85% compliant with sitagliptin placebo treatment during the single-blind run-in period (as determined by site-performed capsule/tablet count).
排除标准
- 未提供
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