NCT05688332

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

Comparison of Glycaemic and Cardiovascular Treatment Outcomes of Voglibose Versus Glibenclamide Added to Metformin in T2DM Patients in Zambia: An Open-label Randomised Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: University of Zambia · Academic / Other
• Sex: All
• Age: 22 Years – 59 Years
• Healthy volunteers: Not accepted

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-).

Detailed description

BACKGROUND: Diabetes is an increasingly important risk factor for CVD. Individuals with it continually have an increased risk of CV caused mortality. It can be classified as T1DM, T2DM, GDM and others. Metformin is a T2DM 1st line Oral Hypoglycaemic Agent (OHA). It usually requires a 2nd line add-on drug if blood glucose control is not on target. The add-on drug can either be insulin, an injectable incretin mimetic, or an OHA. The choice of the OHA should be considered with regard to improving the glycaemic control as well as reducing the CVD risk. Glibenclamide, a Sulphonylurea (SU), is a commonly used OHA in Zambia. It is associated with hypoglycaemia and arrhythmias. On the other hand voglibose, an alpha glucosidase inhibitor (AGI), is not associated with hypoglycaemia or with negative CV events. AGIs are associated with reduced PPBG by reducing the absorption of glucose in the GI tract after a carbohydrate meal. Reduced PPBG prevents macrovascular complications. Since maize (a carbohydrate) is a staple food in Zambia, there is need to investigate the glycaemic control in patients with T2DM using voglibose which is as affordable as glibenclamide. MAIN AIM: To investigate the extent of glycaemic control and CV risk parameter effects of voglibose versus glibenclamide add-on therapies in Zambian patients with T2DM as we do not have published studies on these parameters in our patients. METHOD: This study will be a 12 weeks dual-center open-label randomised clinical trial to comparatively evaluate the glycaemic and CV treatment outcomes of voglibose vs glibenclamide add-on therapies in native Zambian patients with T2DM inadequately controlled on 1g/day of metformin monotherapy. In this study, glycaemic and CV parameters will be quantified and classified in the laboratory to determine extent of glycaemic control and CVD risk reduction. Participants to be included will be male and female native Zambian patients aged 22 to 59 years on metformin monotherapy for at least 12 weeks with HbA1c \> 7.0%. They will be randomly allocated by study team members to two treatment arms i.e., the voglibose-metformin or the glibenclamide-metformin regimen in a 1:1 computer generated simple randomisation. The participants will then be followed up to the 6th and 12th week for data collection prior to comparative analysis of the expected outcome. EXPECTED OUTCOME: Change in glycaemic and CV parameters in the two groups after 6 and 12 weeks of add-on therapy. SIGNIFICANCE: To help determine the glycaemic and CV risk status of patients with T2DM on voglibose and glibenclamide, thereby ascertain improvement in their healthcare and treatment outcomes.

Conditions

• Diabetes Mellitus Type 2 Without Complication

Interventions

Type	Name	Description
DRUG	Voglibose + Metformin	In treatment group B, 59 participants will also be randomly assigned to the voglibose 0.2/0.3mg TDS + metformin 500mg BD treatment combination to be taken orally daily, during or immediately after meals with dose titration at day 6 and 12 if the average fasting blood glucose (FBG) level is ≥7 mmol/L (126 mg/dL) and then dosage will be maintained for the remainder of the treatment period Participants in the intervention group initially receiving voglibose 0.2mg + metformin 500mg BD will be dose-titrated to voglibose 0.3mg +metformin 1g BD. The duration of therapy for each participant will be 12 weeks, which is the minimum period for evaluating the primary endpoint.
DRUG	Glibenclamide + Metformin	The drugs (glibenclamide + metformin), in the control or comparator group will also be taken orally, glibenclamide once a day (OD) before meals, and metformin twice a day (BD) also before meals. These drugs will also be taken with a dose-titration at days 6 and 12 if the average is FBG level will be ≥ 7 mmol/L and the dose will be maintained for the remainder of the study period. The duration of therapy for each participant will be 12 weeks, which is the minimum period for evaluating the primary endpoint. In this group, participants will initially receive glibenclamide 5mg once daily (OD) + metformin 500mg BD then will be dose-titrated to glibenclamide 10mg OD + metformin 1g BD.

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-12-01
• Completion: 2024-01-01
• First posted: 2023-01-18
• Last updated: 2023-07-03