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

NCT ID: NCT01757587

Last Updated: 2015-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2015-03-31

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

Detailed Description

• 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).

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vildagliptin

Group Type: ACTIVE_COMPARATOR

Vildagliptin

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Vildagliptin

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Metformin and basal insulin; Metformin and insulin basal

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvia FRANC, MD

Role: PRINCIPAL_INVESTIGATOR

CH Sud Francilien

Locations

CH Sud Francilien

Évry, , France

Countries

France

Other Identifiers

2011-001813-14

Identifier Type: -

Identifier Source: org_study_id