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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-11

Study Completion Date

2019-10-04

Brief Summary

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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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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No