A Phase IIa, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK8245 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 主要终点
- Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4
研究概览
简要总结
A study to assess the safety and efficacy of MK8245 as monotherapy compared to placebo.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have Type 2 Diabetes Mellitus
- •18 to 65 years of age
排除标准
- •History of Type 1 Diabetes or ketoacidosis
- •Have been treated with lipid lowering medications 4 weeks before starting the study
- •Have started on a weight loss program and not in the maintenance phase or have started weight loss medication within the last 12 weeks
- •Have had surgery in the last 30 days
- •History of active liver disease
- •History of coronary heart disease or congestive heart failure
- •Have had a stroke or transient ischemic neurological disorder in the past 6 months
- •Are Human Immunodeficiency Virus (HIV) Positive
研究组 & 干预措施
MK8245 5 mg b.i.d.
MK8245
干预措施: MK8245 5 mg (twice a day) b.i.d. (Drug)
MK8245 50 mg b.i.d.
MK8245
干预措施: MK8245 50 mg b.i.d. (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4
时间窗: Baseline and Week 4
The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A "weighted" rather than a "simple" mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were to be collected immediately prior to (sample -10 minutes), and 0, 15, 30, 60, 90, 120, and 180 minutes after each meal, and overnight (at midnight, 3 AM, and 5 AM) and fasting at 7 AM. Patients were to be domiciled for approximately 26 hours at the site where standard meals were provided and physical activity monitored.
次要结局
未报告次要终点