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临床试验/NCT00952991
NCT00952991已完成3 期

A Double Blind, Cross Over, Placebo Controlled, Multiple-dose Study to Evaluate the Effects of LAF237 on Gastric Emptying, Gastric Volume and Satiety in Patients With Type 2 Diabetes.

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2005年5月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Mayo Clinic
入组人数
18
试验地点
2
主要终点
Gastric Emptying

研究概览

简要总结

Administration of the incretin hormone, Glucagon-Like-Peptide-1 (GLP-1), has been shown to enhance insulin secretion and suppress glucagon secretion in response to meal ingestion. In addition, GLP-1 also delays gastric emptying and has been shown to enhance gastric accommodation. These characteristics make GLP-1 an ideal therapy for type 2 diabetes (T2D). However, because of its rapid breakdown by dipeptidylpeptidase IV (DPP IV), GLP-1 has to be administered by continuous intravenous infusion. This would be a drawback in clinical usage. LAF237 is a synthetic inhibitor of DPP IV which has been shown to raise GLP-1 levels and potentiate meal-induced insulin secretion and glucagon suppression. However, the effects of LAF237 on gastric emptying and satiety are at present unknown. The investigators propose to study the effects of LAF237 on gastric emptying, gastric volume and satiety in patients with T2D in addition to examining the direct and indirect (mediated via insulin and glucagon) of this compound on postprandial glucose metabolism.

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
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes without microvascular or macrovascular complications treated with diet or up to 2 oral agents

排除标准

  • 未提供

结局指标

主要结局

Gastric Emptying

Gastric accommodation

Satiety

Gastrointestinal Symptoms

次要结局

  • Meal Appearance Rate
  • Glucose Disappearance
  • Endogenous Glucose Production
  • Insulin Secretion
  • Glucagon Secretion

研究者

发起方
Mayo Clinic
申办方类型
Other

研究点 (2)

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