Status:
COMPLETED
Observational Study of Effectiveness and Tolerability of Gliclazide MR 60mg in Diabetic Patients Fasting During RAMADAN
Lead Sponsor:
Servier Affaires Médicales
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 4 2019
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT04132934
Start Date
March 11 2019
End Date
October 4 2019
Last Update
June 5 2020
Active Locations (1)
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1
Servier Affaires Medicales
Suresnes, France, 92284