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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Sponsor:
Information provided by (Responsible Party):
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier:
NCT01757587
First received: February 8, 2012
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
Drug: Vildagliptin
Drug: Placebo
Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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


Estimated Enrollment: 34
Study Start Date: December 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vildagliptin Drug: Vildagliptin
50 mg, 2 tablets/day on 3 months, both periods of treatment
Other Name: Metformin and basal insulin
Placebo Comparator: Placebo Drug: Placebo
50mg 2 tablets / day on 3 months, both periods of treatment
Other Name: Metformin and insulin basal

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).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757587

Contacts
Contact: Sylvia FRANC, MD 00(33)61697072 sylvia.franc@free.fr
Contact: Ilham XHAARD, CRA 00(33)164968652 rech4@ceritd.fr

Locations
France
CH Sud Francilien Recruiting
Evry, France, 91000
Sponsors and Collaborators
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Investigators
Principal Investigator: Sylvia FRANC, MD CH Sud Francilien
  More Information

No publications provided

Responsible Party: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier: NCT01757587     History of Changes
Other Study ID Numbers: 2011-001813-14
Study First Received: February 8, 2012
Last Updated: February 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète:
Type 2 Diabetes
Galvus
basal insulin
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014