A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK0941 After Multiple Daily Administration in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Number of Participants With Any Clinical Adverse Experience
研究概览
简要总结
A study to test the pharmacokinetics after twice daily administration of MK-0941 or placebo in subjects with type 2 diabetes who have inadequate control on metformin.
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
- •Subject has a BMI < 42 kg/m2
- •Subject is taking >1500 mg metformin per day for at least 8 weeks
- •Subject has HbA1c value of 7.0% and < 11% at screening
- •Subject is willing to follow AHA weight maintaining diet and exercise program
- •Subject is a nonsmoker for at least 6 months
排除标准
- •Subject has type 1 diabetes
- •Subject has a history of stroke or chronic seizure
- •Subject has a history of neoplastic disease
- •Subject has a history of gastrointestinal, cardiovascular, blood, liver kidney, respiratory, immunological or genitourinary disorders or diseases
- •Subject is currently taking 2 or more diabetes medications
- •Subject has glaucoma or is blind
- •If female, subject is pregnant or breastfeeding
- •Subject consumes > 3 alcoholic beverages per day
- •Subject has had major surgery or has donated blood in the last 4 weeks
研究组 & 干预措施
1
MK-0941
干预措施: MK-0941 (Drug)
结局指标
主要结局
Number of Participants With Any Clinical Adverse Experience
时间窗: 2 months
An adverse experience was defined as any unfavorable and unintended change in the structure or function of the body temporally associated with the use of study drug. Adverse experiences were collected using Medical Dictionary for Regulatory Activities (MedDRA) version 13.0.
Number of Participants With Any Laboratory Adverse Experience
时间窗: 2 months
Laboratory adverse experiences were those related to changes in hematology, fasted blood chemistry, or urinalysis laboratory results. Adverse experiences were collected using MedDRA version 13.0.
Change From Baseline to Day 13 in Weighted Mean Plasma Glucose Concentration
时间窗: Baseline (predose Day 1) to Day 13
Weighted mean plasma glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24
次要结局
未报告次要终点