drugset / Trial / NCT01757587

Galvus (Vildagliptin) vs Placebo in Combination With Metformin and Insulin

NCT01757587

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

EvaluationDrugModalityDoseRoute
Comparator Vildagliptin Other / unclassified 50 mg