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

Servier Affaires Médicales1,200 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,200

Conditions

Type 2 Diabetes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Servier Affaires Medicales

Suresnes, France

Outcomes

Primary Outcomes

Proportion of patients with at least one Hypoglycemia event

Time frame: up to 5 months

Data from ClinicalTrials.gov

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