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Completed

NCT Number: NCT04132934

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

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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

  1. 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.

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