NCT01147276已完成4 期
Study of the Effect of Vildagliptin on Glucagon Counterregulation Response During Hypoglycemia in Patients With Type 1 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Glucagon response to hypoglycemia
研究概览
简要总结
The study examines whether DPP-4 inhibition by vildagliptin affects the glucagon counterregulatory response to hypoglycemia in type 1 diabetes.
详细描述
Vildagliptin (50 mg BID) or placebo is given as add-on to insulin treatment for four weeks in patients with type 1 diabetes. Then, a hypoglycemic clamp (2.5 mmol/l glucose) is undertaken with the determination of glucagon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Type 1 diabetes
- •Age >18 years
- •HbA1c 6.5-8,5%
排除标准
- •Pregnancy
- •Lactation
- •Acute infection
- •Liver disease
- •Treatment with cortisol
研究组 & 干预措施
Vildagliptin
Experimental
Vildagliptin (50 mg BID) given for four weeks
干预措施: Vildagliptin (Drug)
结局指标
主要结局
Glucagon response to hypoglycemia
时间窗: 45 min
Change in glucagon from before hypoglycemic clamp until after 45 min
次要结局
- Catecholamine response to hypoglycemic(45 min)
研究者
研究点 (1)
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