Review on the laboratory analysis and patient monitoring of generic and branded drug for type 2 diabetes melitus: a focus on efficacy, lipid profile and sugar level.

Abstract

Context: Insulin resistance and poor glucose metabolism are hallmarks of Type-2 Diabetes Mellitus (T2DM), a chronic illness that calls for long-term pharmaceutical treatment. A common prescription drug used to control blood glucose levels is metformin. It is critical to evaluate the safety and effectiveness of branded and generic formulations, particularly with regard to glycemic management, lipid profiles, and renal function, given the growing availability of generic medications. Evaluation test for tablets: The purpose of this study was to analyze and assess the efficacy of several marketed brands of metformin pills, both branded and generic. Two 500 mg tablets Glumetza (branded) and okamet 500mg (generic) were chosen, and their chemical and physical properties were assessed. Official standards, such as thickness, hardness, weight fluctuation, friability, disintegration time, and dissolution studies, PH measurement, Assay of API, Identification of impurities, were used to assess each brand’s physicochemical equivalency. Objective: The objective of this study was to compare the safety and effectiveness of branded and generic forms of metformin in patients with Type-2 Diabetes Mellitus over a six-month period, with an emphasis on lipid profiles, renal function, and glycemic control. Materials & Procedures: Patients with type 2 diabetes were split into two groups and given either generic or branded versions of diabetes medications. At baseline, three months, and six months, fasting blood sugar (FBS) and HBA1C values were used to measure glycemic control. The safety and possible effects on renal function were assessed by measuring serum creatinine and lipid profiles, which include cholesterol levels. Outcomes: Over a six-month period, both branded and generic Metformin shown notable drops in HBA1C, with the former going from 8.00% to 6.80% and the latter from 8.00% to 6.90%. FBS levels dropped from 190 mg/dl to 177 mg/dl for branded products and 182 mg/dl for generic products. The branded group experienced a greater drop in cholesterol (from 198 mg/dl to 180 mg/dl) than the generic group (to 185 mg/dl). The levels of serum creatinine stayed constant. Conclusion: There was no discernible difference in the safety profiles of branded and generic forms of metformin, and both were equally successful in enhancing lipid profiles and glycemic management.