Observational Study of Effectiveness and Tolerability of Gliclazide MR 60mg in Diabetic Patients Fasting During RAMADAN

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT04132934
• Lead Sponsor: Servier Affaires Médicales

Brief Summary

The purpose of this observational study is to assess effectiveness and tolerability of gliclazide MR 60mg during RAMADAN in a real world setting in 9 countries from Asia Pacific and Middle East/North Africa

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-11
• Primary Completion: 2019-10-04
• Study Completion: 2019-10-04
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-18
• Study First Posted: 2019-10-21
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-03
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Informed consent obtained before any trial-related activities
• Male or female type 2 diabetic patients aged >18 years
• Patients with controlled or suboptimal controlled type 2 diabetes
• Patients with experience in SMBG controlling using glucometer
• Patients who are willing to fast during Ramadan
• Patients already treated with Gliclazide MR 60mg

Exclusion Criteria

• Insulin therapy requirement
• Severe liver or renal failure
• HbA1c ≥ 9%
• Contraindication to gliclazide according to SmPC
• Pregnancy or breast feeding
• Previous experience of severe or repeated hypoglycemia events without triggered factor within the previous year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with at least one Hypoglycemia event	up to 5 months

Trial Locations

Locations (1)

Servier Affaires Medicales; 🇫🇷 Suresnes, France