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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04132934

Acronym

DIA-RAMADAN

Enrollment

1200

Registered

2019-10-21

Start date

2019-03-11

Completion date

2019-10-04

Last updated

2020-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proportion of patients with at least one Hypoglycemia event	up to 5 months

Countries

France

Outcome results