Glycaemic & Cardiovascular Treatment Outcomes of Voglibose Vs Glibenclamide Added to Metformin in T2DM Patients
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-).
Timeline
- Start
- 2023-08
- Primary completion
- 2023-12
- Completion
- 2024-01
Publications
- Background American Diabetes Association Professional Practice Committee. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022 Jan 1;45(Suppl 1):S17-S38. doi: 10.2337/dc22-S002.
- Background Rosenquist KJ, Fox CS. Mortality Trends in Type 2 Diabetes. In: Cowie CC, Casagrande SS, Menke A, Cissell MA, Eberhardt MS, Meigs JB, Gregg EW, Knowler WC, Barrett-Connor E, Becker DJ, Brancati FL, Boyko EJ, Herman WH, Howard BV, Narayan KMV, Rewers M, Fradkin JE, editors. Diabetes in America. 3rd edition. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases (US); 2018 Aug. CHAPTER 36. Available from http://www.ncbi.nlm.nih.gov/books/NBK568010/
- Background Coleman RL, Scott CAB, Lang Z, Bethel MA, Tuomilehto J, Holman RR. Meta-analysis of the impact of alpha-glucosidase inhibitors on incident diabetes and cardiovascular outcomes. Cardiovasc Diabetol. 2019 Oct 17;18(1):135. doi: 10.1186/s12933-019-0933-y.
- Background Akmal M, Patel P, Wadhwa R. Alpha Glucosidase Inhibitors. 2024 Feb 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557848/
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glyburide | Small molecule | 10 mg | Oral |
| Subject | Metformin | Small molecule | 1 g | Oral |
| Subject | Voglibose | Small molecule | 0.3 mg | Oral |