NCT00511667已完成1 期
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Sequential Panel Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK0941 After Multiple Daily Administration of MK0941 Before Each Meal (q.a.c.) in Subjects With Type 2 Diabetes
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
- Participants With Any Clinical Adverse Experience
研究概览
简要总结
A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily MK-0941 in subjects with T2DM with or without adequate control on metformin will be sufficiently safe and well tolerated to permit continued clinical investigation.
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
- •Nonsmoking Male or Female (of non-child bearing potential)
- •Diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or with less than 3 oral anti-hyperglycemic agents
- •Panel E only (MK0941 60 mg before 2 meals each day): diagnosis of Type 2 Diabetes and is on a dose of metformin of greater than or equal to 1500 mg for 8 weeks or more
排除标准
- •Subject is on insulin or a peroxisome proliferator-activated receptor (PPAR) agonist
- •Subject is on 3 or more oral anti-diabetes medications
- •Subject has a history of type 1 diabetes
- •Subject has a diagnosis of glaucoma or is blind
- •Subject has had trauma to one or both eyes
研究组 & 干预措施
MK0941
Experimental
干预措施: MK0941 (Drug)
结局指标
主要结局
Participants With Any Clinical Adverse Experience
时间窗: Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)
Participants Discontinued Because of Any Clinical Adverse Experience
时间窗: Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)
次要结局
- Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941(Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day))
- Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941(Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day))
- Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941(Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day))
- Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941(Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day))
- Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941(Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day))
研究者
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