Glycaemic & Cardiovascular Treatment Outcomes of Voglibose Vs Glibenclamide Added to Metformin in T2DM Patients

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical trial is to compare blood-sugar 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-).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zambia
• Collaborator: University Teaching Hospital, Lusaka, Zambia
• Treatments: Glyburide; Metformin; Voglibose

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.