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临床试验/NCT00972322
NCT00972322
已完成
1 期

A Placebo-Controlled Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacokinetics of MK-8245 in Subjects With Type 2 Diabetes

Merck Sharp & Dohme LLC0 个研究点目标入组 56 人2009年8月24日

概览

阶段
1 期
干预措施
MK-8245
疾病 / 适应症
Type 2 Diabetes Mellitus
发起方
Merck Sharp & Dohme LLC
入组人数
56
主要终点
Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)
状态
已完成
最后更新
7年前

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.

注册库
clinicaltrials.gov
开始日期
2009年8月24日
结束日期
2010年1月26日
最后更新
7年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

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

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.

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