NCT00511472已完成1 期
A Multicenter, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0941 on Postprandial Plasma Glucose Concentrations After Daily Administration MK-0941 Before Each Meal (q.a.c) in Subjects With Type 2 Diabetes Being Treated With Basal Insulin
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- Number of Participants Who Experienced an Adverse Event During the Study
研究概览
简要总结
A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type 2 diabetics being treated with basal insulin.
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 (Participant, Investigator)
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
- •Male or female (of non-childbearing potential) between 18 to 70 years of age
- •Diagnosed with Type 2 Diabetes and currently being treated with basal insulin
- •Smokers may participate, but they are limited to 10 cigarettes per day while at the clinic and must follow clinic smoking rules
排除标准
- •History of Type 1 diabetes
- •Treated with peroxisome proliferator-activated receptor (PPAR) agonists within 12 weeks prior to study start
- •History of severe hypoglycemia
- •Allergic to insulin
研究组 & 干预措施
MK-0941
Experimental
干预措施: MK-0941 (Drug)
MK-0941
Experimental
干预措施: LANTUS insulin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
干预措施: LANTUS insulin (Drug)
结局指标
主要结局
Number of Participants Who Experienced an Adverse Event During the Study
时间窗: 39 days
次要结局
- Number of Participants Who Experienced an Adverse Event - Titration Scheme 1(25 days)
- Number of Participants Who Experienced an Adverse Event - Titration Scheme 2(25 days)
- 24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7(24 hours)
- Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period(Outpatient Days 1 to 14)
研究者
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