NCT00888238已完成1 期
A Randomized Clinical Trial to Evaluate Glucose-Dependent Insulinotropic Effects of a Single Dose of a DPP-4 Inhibitor in Lean Healthy Males
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose
研究概览
简要总结
This study will evaluate the effect of a single dose of sitagliptin on glucose dependent insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG) procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is an Asian Indian male between 18 to 45 years of age
- •Subject is in good health
- •Subject is a nonsmoker or has not used nicotine-containing products for six months
- •Subject is willing to avoid strenuous activity
排除标准
- •Subject has a history of stroke, seizures, or major neurological disorders
- •Subject has irritable bowel disease or recurrent nausea, vomiting, diarrhea, or abdominal pain
- •Subject has a history of high blood pressure requiring treatment
- •Subject has history of cancer
- •Subject has a history of diabetes
研究组 & 干预措施
Sitagliptin/Sitagliptin/Placebo
Experimental
Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
干预措施: sitagliptin (Drug)
Sitagliptin/Placebo/Sitaglipitin
Experimental
Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
干预措施: sitagliptin (Drug)
Placebo/Sitagliptin/Sitagliptin
Experimental
Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
干预措施: sitagliptin (Drug)
结局指标
主要结局
Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose
时间窗: 190 minutes to 340 minutes
ISR was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters.
次要结局
- Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose(190 minutes to 340 minutes)
研究者
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