A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs)
研究概览
简要总结
A 2-period crossover study to assess the safety, tolerability and glucose-lowering effects of MK8245.
详细描述
Hypothesis
Multiple doses of MK-8245 are sufficiently safe and well tolerated in patients with Type 2 diabetes based on an assessment of clinical and laboratory adverse experiences (AEs), to permit continued clinical investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 or a single oral anti-hyperglycemic agent
- •Subject is willing to follow the weight-maintaining diet and exercise program or equivalent beginning 4 weeks before receiving study drug, throughout the study and until the post study visit
- •Subject has been a nonsmoker and/or has not used nicotine-containing products for at least approximately 6 months
排除标准
- •Subject has a history of stroke, chronic seizures, or major neurological disorder
- •Subject has a history of neoplastic disease (except non-melanomatous skin carcinoma, carcinoma in situ of the cervix, other malignancies successfully treated at least 10 years prior to screening, or malignancies deemed highly unlikely to recur.)
- •Subject has a history of Type 1 Diabetes Mellitus and/or history of ketoacidosis
- •Subject has a history of contact lens use within approximately the previous 6 months
- •Subject has been diagnosed with dry eye syndrome
- •Subject has used lipid-lowering therapies in the past 3 months (Subjects on a stable monotherapy dose of statins may be included)
- •Subject has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks of starting in the study
研究组 & 干预措施
1
MK8245
干预措施: MK8245 (Drug)
结局指标
主要结局
Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs)
时间窗: 56 days
An LAE is defined as any unfavorable \& unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A CAE is defined similarly but also includes changes in structure or function of the body. Serious AEs are those occuring that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc. Drug-relatedness was determined by the investigator based on clinical judgement.
Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14
时间窗: Day 14 of each 14-day Treatment Period
Changes in HGP were determined during a euglycemic clamp procedure. HGP was evaluated as milligrams per kilogram of glucose produced per minute.
次要结局
未报告次要终点