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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Servier Affaires Medicales

Suresnes, 92284, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Proportion of patients with at least one Hypoglycemia event

Time frame: up to 5 months

Sponsors and collaborators

Lead sponsor

Servier Affaires Médicales

Industry

Registry information

Official study title

Observational Study Program Assessing Effectiveness and Tolerability of Gliclazide MR 60mg in Patients With Type 2 Diabetes Fasting During RAMADAN

Acronym: DIA-RAMADAN

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Oct 21, 2019
Registry last updated: Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed