NCT00390520已完成3 期
A Single-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Assess the Effect of Vildagliptin on Glucagon Counterregulatory Response During Hypoglycemia in Patients With Type 2 Diabetes.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Glucagon counterregulatory response to hypoglycemia of the last 30 min of the 2.5 mM hypoglycemic clamp after 4 weeks treatment
研究概览
简要总结
This mechanistic study is designed to investigate the effect of vildagliptin on the sensitivity of the a-cell to glucose under hypoglycemic conditions in patients with type 2 diabetes (T2DM).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with T2DM, diagnosed at least 6 weeks prior to visit 1, who have had no treatment with oral antidiabetic agents for at least 12 weeks prior to study entry (visit 1) and no treatment with oral antidiabetic agents at any time in the past for > 3 consecutive months
- •>/= 18 years
- •Body mass index in the range of 22-35 kg/m2
- •HbA1c </=7.5%
排除标准
- •Type 1 diabetes
- •Acute metabolic diabetic complications
- •Evidence of significant diabetic complications
- •Insulin treatment within the past 6 months
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Glucagon counterregulatory response to hypoglycemia of the last 30 min of the 2.5 mM hypoglycemic clamp after 4 weeks treatment
次要结局
- Glucagon counterregulatory response to hypoglycemia assessed as glucagon Cmax of the 2.5 mM hypoglycemic clamp step after 4 weeks treatment
- The 'insulin secretion rate relative to glucose' at the hypoglycemic clamp step after 4 weeks treatment
- Change from baseline on hemoglobinA1c (HbA1c)and fasting plasma glucose
- Safety based primarily on frequency of adverse events, number of notable abnormal laboratory values, and frequency and severity of hypoglycemic events
研究者
研究点 (1)
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