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:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT05688332
Eligibility Criteria:
Inclusion Criteria:
* In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Provision of signed and dated informed consent form.
* Stated willingness to comply with all study1 procedures and availability for the durtion of the study.
* Male or female, aged 22-59 years.
* In good general health as evidenced by medical history, diagnosed with T2DM and on tolerated dose of at least 2g/day of metformin monotherapy.
* Ability to take oral medication and be willing to adhere to the medication regimen through out the study period.
* For females of reproductive potential use of highly effective contraception.
* Native-Zambian participants
* Must be on metformin monotherapy for 12 weeks or longer.
* Glycated haemoglobin (HbA1c) must be \>7.0% within 12 weeks before screening.
Exclusion Criteria:
* An individual who meets any of the following criteria will be excluded from participation in this study:
* Hypersensitivity or contraindication to AGIs
* Hypersensitivity or contraindication to SUs
* Type 2 diabetes patients with pregnancy or lactation
* Patients with acute complications like diabetic ketoacidosis, or hyperosmolar hyperglycaemic state at the time of screening
* Patients with established cardiovascular disease, e.g.; HF, coronary artery disease
* Patients with altered haemoglobin levels, e.g.; in conditions like anaemias and haemoglobimopathies such as thalassemia
* Patients on concomitant corticosteroid therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
59 Years
Study:
NCT05688332
Study Brief:
Protocol Section:
NCT05688332