Glycaemic & Cardiovascular Treatment Outcomes of Voglibose Vs Glibenclamide Added to Metformin in T2DM Patients (VMGMProtocol)
Diabetes Mellitus Type 2 Without Complication
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2 Without Complication focused on measuring voglibose, Metformin, Glibenclamide, Outcomes
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Voglibose + Metformin (Group B)
Glibenclamide + Metformin (Group A)
In the B treatment group, 59 participants will be randomly assigned to initially voglibose 0.2mg TDS immediately before meals + metformin 500mg BD immediately before meals daily. Individual drug doses will be adjusted to the next higher doses after 6 to 12 days, at next clinical visits based on home based recorded blood glucose profiles. The maximum daily recommended dose of metformin of 2g and voglibose 0.9mg will not be exceeded.
In treatment group A, 59 participants will initially be randomly allocated by study team members to the glibenclamide 5mg O.D + metformin 500mg BD regimen. In this study, 10mg glibenclamide and 2g metformin will not be exceeded daily.