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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.

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.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-006754-10-FR
Enrollment
100
Registered
2007-01-25
Start date
2007-03-14
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus non insulino dependant MedDRA version: 9.1 Level: SOC Classification code 10027433 Term: Metabolism and nutrition disorders

Interventions

Trade Name: DIAMICRON 30 mg Pharmaceutical Form: Modified-release tablet INN or Proposed INN: gliclazide Current Sponsor code: S05702 Concentration unit: mg milligram(s) Concentration type: equal Conc

Sponsors

Institut de Recherches Internationales Servier
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: - Type 1 diabetes - Pregnancy, breast-feeding or female of childbearing potential, - Contra-indication to gliclazide, - Recent major cardiovascular events.

Design outcomes

Primary

MeasureTime frame
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—

Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026