Observational Study of Effectiveness and Tolerability of Gliclazide MR 60mg in Diabetic Patients Fasting During RAMADAN
DIA-RAMADAN
Observational Study Program Assessing Effectiveness and Tolerability of Gliclazide MR 60mg in Patients With Type 2 Diabetes Fasting During RAMADAN
1 other identifier
observational
1,200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2019
CompletedFirst Submitted
Initial submission to the registry
October 16, 2019
CompletedFirst Posted
Study publicly available on registry
October 21, 2019
CompletedJune 5, 2020
June 1, 2020
7 months
October 16, 2019
June 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients with at least one Hypoglycemia event
up to 5 months
Eligibility Criteria
Patients with type 2 diabetes observing fast during Ramadan
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Servier Affaires Medicales
Suresnes, 92284, France
Related Publications (2)
Hassanein M, Al Sifri S, Shaikh S, Abbas Raza S, Akram J, Pranoto A, Rudijanto A, Shaltout I, Fariduddin M, Mohd Izani Wan Mohamed W, Al Awadi F, Alessa T; DIA-RAMADAN study investigators. A real-world study in patients with type 2 diabetes mellitus treated with gliclazide modified-release during fasting: DIA-RAMADAN. Diabetes Res Clin Pract. 2020 May;163:108154. doi: 10.1016/j.diabres.2020.108154. Epub 2020 Apr 21.
PMID: 32330510RESULTHassanein M, Al Sifri S, Shaikh S, Raza SA, Akram J, Rudijanto A, Shaltout I, Fariduddin M, Mohamed WMIBW, Al Awadi F, Durocher A, Cortese V, Alessa T. Descriptive Regional Subanalysis of a Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide MR During Fasting: DIA-RAMADAN. Diabetes Ther. 2021 Jun;12(6):1703-1719. doi: 10.1007/s13300-021-01067-1. Epub 2021 May 11.
PMID: 33974216DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2019
First Posted
October 21, 2019
Study Start
March 11, 2019
Primary Completion
October 4, 2019
Study Completion
October 4, 2019
Last Updated
June 5, 2020
Record last verified: 2020-06