| Trial ID: | L7286 |
| Source ID: | NCT01757587
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Galvus (Vildagliptin) vs Placebo in Combination With Metformin and Insulin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Vildagliptin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Proportion of patients responding to treatment (HbA1c less than 7%), after 3 months of treatment with Galvus or placebo | Secondary: 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: Evaluate more precisely the optimized glycemic control through a glycemic holter, Safety criteria: number of symptomatic hypoglycemia episodes and number of severe hypoglycemic events, after 3 months of treatment with Galvus or placebo
|
| Sponsor/Collaborators: |
Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
39
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-12
|
| Completion Date: |
2015-03
|
| Results First Posted: |
|
| Last Update Posted: |
2015-07-30
|
| Locations: |
CH Sud Francilien, Evry, 91000, France
|
| URL: |
https://clinicaltrials.gov/show/NCT01757587
|
