A Study of Higher Single Doses of MK-0941 in Type 2 Diabetics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Number of Participants Who Experienced One or More Adverse Events During the Study
研究概览
简要总结
This study will evaluate the safety and tolerability of single doses of MK-0941 based on assessment of clinical and laboratory adverse experiences
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
- •Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control
- •Diagnosis of Type 2 Diabetes and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent
- •No treatment with three of more anti-hyperglycemic agents or any treatment regimen that includes insulin
- •In good health (except for Type 2 Diabetes)
- •Willingness to follow a specific diet throughout the study (consisting of 50% carbohydrates, 20%protein and 30% fat)
- •Nonsmoker
排除标准
- •History of stroke, chronic seizure or major neurological disorder
- •History of cancer
- •History of Type 1 Diabetes
- •Recent history of eye infection
- •Glaucoma or blindness
- •Eye surgery (by incision or laser) within the past three months
研究组 & 干预措施
Treatment Sequence 1
Period 1: Placebo - Period 2: 80 mg - Period 3: 100 mg - Period 4: Placebo - Period 5: 140 mg
干预措施: MK-0941 (Drug)
Treatment Sequence 2
Period 1: 60 mg - Period 2: 80 mg - Period 3: 100 mg - Period 4: 120 mg - Period 5: Placebo
干预措施: MK-0941 (Drug)
Treatment Sequence 3
Period 1: 60 mg - Period 2: Placebo - Period 3: 100 mg - Period 4: 120 mg - Period 5: 140 mg
干预措施: MK-0941 (Drug)
Treatment Sequence 4
Period 1: 60 mg - Period 2: 80 mg - Period 3: Placebo - Period 4: 120 mg - Period 5: 140 mg
干预措施: MK-0941 (Drug)
结局指标
主要结局
Number of Participants Who Experienced One or More Adverse Events During the Study
时间窗: Up to 30 days after the last dose of study drug
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
时间窗: Up to 6 weeks after the first dose of study drug
Only treatment-emergent adverse events were examined for this outcome measure.
次要结局
未报告次要终点