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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète; Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Treatments: Insulin; Insulin, Globin Zinc; Metformin; Vildagliptin

Criteria

Inclusion Criteria:

• Patients treated for at least 3 months with metformin (at the maximum tolerated dose (for at least 1 month) + / - sulfamide and basal insulin

• Patient with an HbA1c between 7 and 9% at the inclusion visit

• Patients able to use a continuous glucose monitoring system,

Exclusion Criteria:

• Patients already receiving a specific treatment of postprandial (GLP1, ..)

• Patients with type 1 diabetes, or secondary diabetes

• Patients with eating disorders

• Patients with major complications of diabetes

• Patients participating in another clinical trial

• Pregnant