Glycaemic & Cardiovascular Treatment Outcomes of Voglibose Vs Glibenclamide Added to Metformin in… (NCT05688332) | Clinical Trial Compass
UnknownPhase 3
Glycaemic & Cardiovascular Treatment Outcomes of Voglibose Vs Glibenclamide Added to Metformin in T2DM Patients
118 participantsStarted 2023-08
Plain-language summary
The goal of this clinical trial is to compare blood-sugar control and blood circulatory system risk-position in type 2 diabetes patients on voglibose versus those on glybenclamide when the two drugs are added to metformin because metformin alone is not controlling the blood-sugar well. The results of this trial will help in improving the health and treatment results of the type 2 diabetic patients.
The main question the trial aims to answer is whether there is a difference in blood-sugar and blood circulatory system treatment results between voglibose + metformin and glibenclamide + metformin treatment combinations.
Participants that agree to participate in the trial will be asked to provide a sample of blood so that the following measurable laboratory factors will be used to compare any differences in treatment results between the two treatment groups from the beginning to the end of the trial:
* Total Cholesterol (TC),
* Low Density Lipoproteins (LDL-c),
* High Density Lipoproteins (HDL-c),
* Fasting Triglycerides (FTG),
* Fasting blood sugar (FBS),
* Post prandial blood sugar (PPBG),
* Glycated hemoglobin (HbA1c) correlated to hemoglobin level,
* creatinine,
* blood urea and
* electrolytes (K+, Na+, Cl-).
Who can participate
Age range
22 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 conco…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.