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.

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 Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Vildagliptin; Drug: 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).

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Evry, France, 91000
    • CH SUd Francilien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 50mg 2 tablets / day on 3 months, both periods of treatment; Other Names: Metformin and insulin basal
Active Comparator: Vildagliptin	Drug: Vildagliptin; 50 mg, 2 tablets/day on 3 months, both periods of treatment; Other Names: Metformin and basal insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients responding to treatment (HbA1c less than 7%)	after 3 months of treatment with Galvus or placebo

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
• Investigators: Principal Investigator: Sylvia FRANC, MD, CH SUd Francilien

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: February 8, 2012
• First Submitted That Met QC Criteria: December 21, 2012
• First Posted (Estimate): December 31, 2012

Study Record Updates

• Last Update Posted (Estimate): July 30, 2015
• Last Update Submitted That Met QC Criteria: July 29, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: HbA1c; Type 2 Diabetes; Galvus; basal insulin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Insulin; Insulin, Globin Zinc; Metformin; Vildagliptin
• Other Study ID Numbers: 2011-001813-14