NCT00396071已完成3 期
A Single-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Assess the Effect of Vildagliptin on the Incretin Effect in Patients With Type 2 Diabetes Treated With Metformin
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in C-peptide IAUC (0-4hr)
研究概览
简要总结
This mechanistic study will evaluate the effect of vildagliptin on glucose-stimulated insulin secretion to improve the incretin effect 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
入排标准
- 年龄范围
- 30 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes on metformin for at least 3 months and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks
- •Agreement to maintain the same dose of metformin throughout the study
- •Body mass index (BMI) in the range of 22-35 kg/m2
- •HbA1c in the range of 7.0 to 9.0%
- •FPG <200 mg/dl (11.1 mmol/L)
- •Agreement to maintain prior diet and exercise habits during the full course of the study
- •Ability to comply with all study requirements and signed informed consent to participate in the study
排除标准
- •A history of type 1 diabetes
- •A history of acute metabolic diabetic complications
- •Evidence of significant diabetic complications
- •Insulin treatment for longer than 10 days within the past 6 months
- •Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Experimental
Vildagliptin 100 mg qd
干预措施: vildagliptin (Drug)
2
Placebo Comparator
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in C-peptide IAUC (0-4hr)
时间窗: 2 weeks after treatment
次要结局
- Change in postprandial insulin(after two weeks of treatment)
- Change in postprandial GLP-1(after 2 weeks of treatment)
- Change in insulin secretion rate (ISR) relative to glucose (0-2hr)(after 2 weeks of treatment)
- Change in postprandial C-peptide(after two weeks of treatment)
- Change in postprandial glucagon(after two weeks of treatment)
研究者
研究点 (2)
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