A Comparative Study of Fixed Dose Combination of Vildagliptin and Glimepiride with Metformin in Type 2 Diabetes Mellitus Patients

Abstract

The efficacy and safety of diabetes treatment should focus on patient-reported outcomes (PROs), Treatment satisfaction is a significant determinant for patients in terms of physical and mental satisfaction, wellbeing and quality of life. This type of study is relevant for patients with chronic diseases such as diabetes. DTSQ is not only used for comparisons between different medications or treatment strategies, but also can be used to assess the quality of diabetes care in clinical settings. newlineMaterial and Methods: A prospective, open label; randomized, parallel group study which was conducted in the Department of Endocrinology with the collaboration of Department of Pharmacology, North Delhi Municipal Corporation and Hindu Rao Hospital Delhi. The study had taken 6 months during a period of April 2021 to October 2021 for treatment study and 6 months from December 2021 to June 2022 for treatment satisfaction study. During that period, out patients was divided into two groups. The patient was selected for the study based on the following inclusion and exclusion criteria. Group A of those who had taken Metformin (500 mg) with Glimepride 2 mg. whereas Group B was received Vildagliptin 50 mg in fixed dose combination with metformin 500 mg. The study was approved by the Institutional Ethics Committee. The follow up visits was done on monthly basis. The patients diagnosed with type 2 DM, attending outpatient clinic was recruited after obtaining clearance from Ethical Review Board and took written informed consent. A baseline demographic data (age, sex, weight, blood pressure, associated diseases, habits, and drug history) was collected at the time of recruitment. HbA1c, FBS and PPBS had done at the time of recruitment. Patients was randomly assigned in (1:1) ratio after randomization to either of two groups. One group was prescribed glimepiride(2mg) +metformin (500mg) twice daily half an hour before meals and other group vildagliptin(50mg) + metformin(500mg) twice half an hour before meals. HbA1c, FBS, PPBS was repeated