drugset / Trial / NCT00952991

The Effects of LAF237 on Gastric Function in Type 2 Diabetes

NCT00952991

Phase 3 Completed 18 enrolled Mayo Clinic Novartis Pharmaceuticals · collab
RandomizedCrossoverDouble-blindTreatment

Summary

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.

Timeline

Start
2005-05
Primary completion
2006-02
Completion
2006-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Vildagliptin Other / unclassified