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

NCT01757587 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2015-07-30

No results posted yet for this study

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

Conditions

Interventions

DRUG

Vildagliptin

50 mg, 2 tablets/day on 3 months, both periods of treatment

DRUG

Placebo

50mg 2 tablets / day on 3 months, both periods of treatment

Sponsors & Collaborators

  • Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

    lead OTHER

Principal Investigators

  • Sylvia FRANC, MD · CH Sud Francilien

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01757587 on ClinicalTrials.gov