drugset / Trial / NCT01757587
Galvus (Vildagliptin) vs Placebo in Combination With Metformin and Insulin
Phase 4
Completed
39 enrolled
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
RandomizedCrossoverQuadruple-blindTreatment
Summary
The main objective is to show that the addition of Galvus versus placebo in patients with type 2 diabetes treated with metformin (at the maximum tolerated dose) and basal insulin properly titrated, allows a greater proportion of patients achieving an HbA1c below 7%. The primary efficacy endpoint was the percentage of patients responding to treatment (HbA1c less than 7%) after 3 months of treatment with Galvus or placebo
Timeline
- Start
- 2011-12
- Primary completion
- 2015-03
- Completion
- 2015-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Vildagliptin | Other / unclassified | 50 mg | — |