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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04132934
Recruitment Status : Completed
First Posted : October 21, 2019
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Servier ( 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

Condition or disease
Type 2 Diabetes

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Study Type : Observational
Actual Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study Program Assessing Effectiveness and Tolerability of Gliclazide MR 60mg in Patients With Type 2 Diabetes Fasting During RAMADAN
Actual Study Start Date : March 11, 2019
Actual Primary Completion Date : October 4, 2019
Actual Study Completion Date : October 4, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Proportion of patients with at least one Hypoglycemia event [ Time Frame: up to 5 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with type 2 diabetes observing fast during Ramadan
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132934


Locations
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France
Servier Affaires Medicales
Suresnes, France, 92284
Sponsors and Collaborators
Servier Affaires Médicales

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Responsible Party: Servier Affaires Médicales
ClinicalTrials.gov Identifier: NCT04132934     History of Changes
Other Study ID Numbers: DIM-05762-004
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gliclazide
Hypoglycemic Agents
Physiological Effects of Drugs