Galvus (Vildagliptin) vs Placebo in Combination With Metformin and Insulin
Evaluation of Galvus (Vildagliptin) Efficacy Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled by Metformin and Basal Insulin, This One Having Been Properly Titrated.
1 other identifier
interventional
39
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 type-2-diabetes
Started Dec 2011
Typical duration for phase_4 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 8, 2012
CompletedFirst Posted
Study publicly available on registry
December 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedJuly 30, 2015
July 1, 2015
3.2 years
February 8, 2012
July 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients responding to treatment (HbA1c less than 7%)
after 3 months of treatment with Galvus or placebo
Secondary Outcomes (1)
Compare HbA1c and other clinical and laboratory parameters (fasting plasma glucose (FPG), fasting lipids, weight)
after 3 months of treatment with Galvus or placebo
Other Outcomes (1)
Evaluate more precisely the optimized glycemic control through a glycemic holter
after 3 months of treatment with Galvus or placebo
Study Arms (2)
Vildagliptin
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
50 mg, 2 tablets/day on 3 months, both periods of treatment
50mg 2 tablets / day on 3 months, both periods of treatment
Eligibility Criteria
You may qualify if:
- Patients treated for at least 3 months with metformin (at the maximum tolerated dose (for at least 1 month) + / - sulfamide and basal insulin
- Patients able to use a continuous glucose monitoring system,
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CH Sud Francilien
Évry, 91000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvia FRANC, MD
CH Sud Francilien
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2012
First Posted
December 31, 2012
Study Start
December 1, 2011
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
July 30, 2015
Record last verified: 2015-07