A Placebo-Controlled Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacokinetics of MK-8245 in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)
研究概览
简要总结
This study will assess the safety, tolerability, pharmacokinetics, and glucose lowering activity of MK-8245 in participants with type 2 diabetes. The primary hypothesis of the study is that after 4 weeks of treatment, MK-8245 produces a greater reduction in 24 hour weighted mean glucose (WMG) from baseline than 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
- •Subject has a diagnosis of type 2 diabetes and is being treated with diet and exercise alone, a single oral anti-hyperglycemic agent or a combination of two oral anti-hyperglycemic agents
- •Subject is willing to follow a weight-maintaining diet and exercise program during the study
- •Subject is a nonsmoker or is willing to limit smoking to 10 cigarettes per day while in the clinical research unit
排除标准
- •Subject has a history of stroke, chronic seizures, or major neurological disorder
- •Subject has a history of cancer, except certain skin and cervical cancers or cancer that was successfully treated 10 or more years prior to screening
- •Subject has a history of type 1 diabetes
- •Subject has used contact lenses within the last 6 months
- •Subject has used any lipid-lowering therapy in the last 3 months, except statins, Zetia, or Vytorin
- •Subject has more than 3 alcoholic beverages per day
- •Subject has more than 6 servings of caffeine a day
- •Subject has participated in a previous MK8245 study
研究组 & 干预措施
MK-8245 50 mg
MK-8245, 50 mg, twice daily for 28 days
干预措施: MK-8245 (Drug)
结局指标
主要结局
Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)
时间窗: Baseline and Day 28
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 collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose.
Number of Participants Who Experienced Serious or Non-serious Adverse Events
时间窗: Up to Day 31
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. A serious AE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Number of Participants Discontinuing Study Drug Due to an AE
时间窗: Up to Day 28
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
次要结局
未报告次要终点