Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT04132934
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04132934
Study Brief:
Protocol Section:
NCT04132934