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

Type 2 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01757587
• Other study ID #: 2011-001813-14
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2012
• Last updated: July 29, 2015
• Start date: December 2011
• Est. completion date: March 2015

Study information

• Verified date: July 2015
• Source: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Vildagliptin
50 mg, 2 tablets/day on 3 months, both periods of treatment
• Placebo
50mg 2 tablets / day on 3 months, both periods of treatment

Locations

Country	Name	City	State
France	CH Sud Francilien	Evry

Sponsors (1)

Lead Sponsor	Collaborator
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Yes
Primary	Proportion of patients responding to treatment (HbA1c less than 7%)		after 3 months of treatment with Galvus or placebo	No
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	No