drugset / Trial / NCT02749032
Feed-Back Suppression of Meal-Induced Glucagon-like Peptide 1 (GLP-1) Secretion
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |