drugset / Trial / NCT02749032

Feed-Back Suppression of Meal-Induced Glucagon-like Peptide 1 (GLP-1) Secretion

NCT02749032

Phase 1 Completed 24 enrolled Michael A. Nauck
RandomizedCrossoverTriple-blindTreatment

Summary

The present study is a phase I, single-centre, double-blind, randomized, cross-over (3 treatments, 3 treatment periods and 6 sequences), stratified (background medication: metformin vs. diet-only), placebo-controlled study, comparing periods lasting 6-9 days on treatment with repeated doses of vildagliptin, sitagliptin, or placebo, with wash-out periods between treatment periods lasting 21 days minimum. The study was designed to directly compare the effects of vildagliptin and sitagliptin on incretin hormone responses, glycaemia, and insulin as well as glucagon secretory responses in patients with type 2 diabetes.

Timeline

Start
2011-11
Primary completion
2014-03
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sitagliptin Small molecule 50 mg Oral
Comparator Sitagliptin Small molecule 100 mg Oral
Comparator Vildagliptin Other / unclassified 50 mg Oral
Comparator Metformin Small molecule 1000 mg Oral