跳至主要内容
临床试验/NCT01219400
NCT01219400已完成4 期

Study of the Effect of Vildagliptin on Glucagon Counterregulation Response During Hypoglycemia in Insulin-treated Patients With Type 2 Diabetes

Lund University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2012年1月最近更新:
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 purpose of this study is to explore whether the novel therapy of type 2 diabetes, vildagliptin, which inhibits dipeptidyl peptidase-4 (DPP-4), affects glucagon counterregulation during hypoglycemia in insulin-treated patients with type 2 diabetes. Vildagliptin is given, together with the on-going insulin therapy, for one month, whereafter hypoglycemia is induced under standardized conditions, and the glucagon response is determined, and compared to that after a month of placebo treatment.

详细描述

Vildagliptin is an inhibitor of dipeptidyl peptidase-4 (DPP-4) and inhibits glucagon secretion and stimulates insulin secretion. This improves glycemia in subjects with type 2 diabetes with a very low risk for hypoglycemia. If hypoglycemia nevertheless develops, it is important that vildagliptin under such conditions does not inhibit glucagon secretion, since that would aggravate the hypoglycemia. It was indeed previously demonstrated in type 2 diabetes that vildagliptin dos not inhibit glucagon secretion during hypoglycemia. This study explores whether vildagliptin affects glucagon counterregulation during hypoglycemia in insulin-treated patients of type 2 diabetes. Vildagliptin is given, together with the on-going insulin therapy, for one month, whereafter hypoglycemia is induced under standardized conditions, and the glucagon response is determined, and compared to that after a month of placebo treatment. The hypoglycemia is induced bvy a standardized clamp procedure.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes
  • Insulin treatment
  • Age >18 years
  • HbA1c <=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 hypoglycemia clamp until after 45 min

次要结局

  • Catecholamine response to hypoglycemia(45 min)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bo Ahren

Professor

Lund University

研究点 (1)

Loading locations...

相似试验