NCT00830076已完成1 期
A Study to Assess the Effects of Co-Administration of Sitagliptin and Metformin on Incretin Hormone Concentrations
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
- 18
- 主要终点
- Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations
研究概览
简要总结
This study will assess the effects of sitagliptin and metformin alone and after co-administration on incretin hormone concentrations in patients with Type 2 diabetes.
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
- •Female subjects must have a negative pregnancy test
- •Subject has type 2 diabetes and is not currently receiving treatment with an oral AHA agent, has not received such treatment for 3 months prior to study, and/or has not received more than 4 total weeks treatment with an oral AHA agent for 12 to 18 months prior to the study
- •Subject is a nonsmoker or has not smoked and/or used nicotine for at least 6 months
排除标准
- •Subject has a history of stroke, seizures, or major neurological disorders
- •Female subject is breastfeeding
- •Subject cannot refrain from use of any prescription or non-prescription drugs beginning 2 weeks prior to first dose of study drug
- •Subject consumes more than 3 alcoholic beverages per day
- •Subject consumes more than 6 caffeinated beverages per day
- •Subject has had major surgery, or has donated or lost 1 unit of blood within 4 weeks of screening
- •Subject has a history of cancer, except certain skin or cervical cancer or other cancers treated more than 10 years prior to screening
- •Subject has a history of multiple and/or severe allergies or intolerance to drugs or food
研究组 & 干预措施
Sitagliptin + placebo metformin
Experimental
干预措施: sitagliptin phosphate (Drug)
Metformin + placebo sitagliptin
Experimental
干预措施: metformin hydrochloride (Drug)
Sitagliptin + metformin
Experimental
Co-administration of sitagliptin and metformin
干预措施: sitagliptin phosphate (Drug)
Sitagliptin + metformin
Experimental
Co-administration of sitagliptin and metformin
干预措施: metformin hydrochloride (Drug)
结局指标
主要结局
Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations
时间窗: 6 hours postdose (4 hours postmeal) on Day 2
Meal was given 2 hours postdose. Blood samples for determination of active GLP-1 concentration were collected (4 hours postmeal) on Day 2 in each treatment period.
次要结局
- Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations(6 hours postdose (4 hours postmeal) on Day 2)
- β-cell Sensitivity(6 hour post-dose (4 hour postmeal) on Day 2)
研究者
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