Efficacy and safety of gliclazide MR (30 to 120 mg per day) associated or not to metformine or to an a-glucosidase inhibitor during the fast of the Ramadan in type 2 diabetic patients.A 5 to 8 months, national, multicentre, open study.Efficacité et tolérance du gliclazide LM (30 à 120 mg/j per os) associé ou non à la metformine ou à un inhibiteur des a-glucosidases pendant le jeûne du Ramadan chez des patients diabétiques de type 2. Etude nationale, multicentrique de 5 à 8 mois de traitement en ouvert.
Phase 1
- Conditions
- Diabetes mellitus non insulino dependantMedDRA version: 9.1Level: SOCClassification code 10027433Term: Metabolism and nutrition disorders
- Registration Number
- EUCTR2006-006754-10-FR
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Inclusion Criteria
- Male or female aged > 35 years inclusive,
- Type 2 diabetic outpatients
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Type 1 diabetes
- Pregnancy, breast-feeding or female of childbearing potential,
- Contra-indication to gliclazide,
- Recent major cardiovascular events.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of gliclazide MR during Ramadan time in type II diabetic patients;Secondary Objective: To assess the safety of gliclazide MR during Ramadan time in type II diabetic patients;Primary end point(s): HbA1C
- Secondary Outcome Measures
Name Time Method