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
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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. Galvus (Vildagliptin) vs Placebo in Combination With Metformin and Insulin|
- Proportion of patients responding to treatment (HbA1c less than 7%) [ Time Frame: after 3 months of treatment with Galvus or placebo ] [ Designated as safety issue: No ]
- Compare HbA1c and other clinical and laboratory parameters (fasting plasma glucose (FPG), fasting lipids, weight) [ Time Frame: after 3 months of treatment with Galvus or placebo ] [ Designated as safety issue: No ]
- Evaluate more precisely the optimized glycemic control through a glycemic holter [ Time Frame: after 3 months of treatment with Galvus or placebo ] [ Designated as safety issue: Yes ]Safety criteria: number of symptomatic hypoglycemia episodes and number of severe hypoglycemic events
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Vildagliptin||
50 mg, 2 tablets/day on 3 months, both periods of treatment
Other Name: Metformin and basal insulin
|Placebo Comparator: Placebo||
50mg 2 tablets / day on 3 months, both periods of treatment
Other Name: Metformin and insulin basal
- Visit V1 : screening
Inclusion visit V2: Be verified inclusion criteria of patient. At the inclusion visit will be collected:
- Informed consent to participate in the study…
- The following data: age, duration of diabetes, usual basal insulin dose, other co-morbidities : hypertension, complications of diabetes, dyslipidemia, smoking (and their associated treatments).
- Data from physical examination and in particular: weight, BMI, waist circumference, systolic blood pressure (SBP) and diastolic (DBP)
- Therapeutic adjustments can be made. In the case of inefficient combination with a sulphonylurea (HbA1c> 7%), it will be stopped and basal insulin will be titrated during the run- in period (2 months) in order to obtain a good control of fasting glucose.
- Visit V3 : At the randomization visit, be collected the results of HbA1c and other biological assessment (FPG, fasting lipid profile). Moreover, the insulin will be collected and the patient will receive the treatment for 3 months (for ex Galvus in this case according to randomisation).
- Visit V4a the glycemic holter will be introduced and removed 5 days later (at visit V4B). The interstitial glucose will be calibrated during the Holter by the blood glucose. When collecting the glycemic holter, patients will also have a clinical examination and a new biological assessment (HbA1c, FPG, C peptide, fasting lipids ...) and an assessment of their dietary intake during the port the holter (overall calorie intake: cal + G, L, P)
- Visit V5 : the patient will receive the treatment for 3 months (placebo at this visit according the example cited above ).
- Visit V6A, it will be the same as for the visit V4a, the glycemic holter will be introduced and removed at V6B visit. Similarly, in the collection of glycemic holter, patients will also have a new clinical examination, laboratory evaluation (HbA1c, FPG, fasting lipids ...) and a dietary assessment (overall calorie intake: cal + G, L, P).
|Contact: Sylvia FRANC, MD||00(33)email@example.com|
|Contact: Ilham XHAARD, CRA||00(33)firstname.lastname@example.org|
|CH Sud Francilien||Recruiting|
|Evry, France, 91000|
|Principal Investigator:||Sylvia FRANC, MD||CH Sud Francilien|