COMPARISON OF GLIMEPIRIDE- METFORMIN VERSUS DAPAGLIFLOZIN- METFORMIN IN PATIENTS WITH TYPE 2 DIABETES

Abstract

The efficacy of common prescribed anti-hyperglycemic agents such as metformin, α-glycosidase inhibitors, dipeptidyl peptidase-4 inhibitors, sulfonylureas, glucagon-like peptide-1 analog, thiazolidinediones, and non- sulfonylurea secretagogues and are insulin-dependent. The efficacy of these drugs is diminished in dysfunction of pancreatic islet β-cells during type 2 diabetes mellitus (T2DM). Comparatively, dapagliflozin, a highly selective inhibitor of sodium glucose co-transporter 2 (SGLT-2), is insulin-independent, control glycemia by reducing reabsorption of glucose by the proximal tubule in the kidney by increasing glucosuria. The aim of the study was to evaluate and compare the efficacy, safety, and tolerability of dapagliflozin with the glimepiride in patients with type 2 diabetes inadequately controlled with metformin monotherapy. The study was conducted in National Medical Center, Karachi on 210 diagnosed patients of type 2 diabetes mellitus. Male and female patient‘s ≥ 45 years of age, fulfilling criteria were included in the study. These patients were systematically randomized into 2 groups each having 105 members. Group A was received tablet Dapagliflozin 10mg once daily plus tablet metformin 500 mg TDS and group B was received tablet glimepiride 4mg once daily plus tablet metformin 500 mg TDS, and for 12 weeks. They were undergoing investigations including HbA1c, FBS, LFTs, RFTs, Lipid Profile, ketonuria, glucosuria, puss cell count, and bacteria. For the analysis, descriptive statistics were calculated using SPSS version 25. The mean fasting blood sugar in group A at week 0, week 6 and week 12 was 184.05±14.82 mg/dL,137.02±12.30 mg/dL and 101.40±16.85 respectively while in group B was 178.19±9.04 mg/dL,146.23±12.54 mg/dL and 121.89±9.22 mg/dL respectively. While, mean Hb1AC in group A at week 0 and week 12 was 7.83±0.54 % and 6.91±0.74 % while mean Hb1AC in group B at week 0 and week 12 was 6.91±0.74 % and 7.91±0.49%. Further we have found significant mean difference for fasting blood sugar and HbA1c at different intervals between the study groups and within the groups. xi Furthermore, the safety profiles of these in patients with type 2 diabetes were evaluated. The normal levels of lipid profile and liver function test were found within and between the groups during week 0, week 6 and week 12. The urine analysis has shown no pyuria, leukocyte esterase and bacteria at week 0, week 6 and week 12. The mean ketone in group A at week 0, week 6 and week 12 was 0.23±0.10 mg/dL,0.23±0.10 mg/dL and 0.22±0.10 mg/d respectively while in group B was 0.31±0.13 mg/dL,0.32±0.13 mg/dL and 0.32±0.13 mg/dL respectively. Furthermore, we found insignificant mean difference for WBC at week 0 (p=0.931), week 6 (p=0.864) and week 12 (p=0.921) with respect to study groups. The difference in glucosuria was identified in 6th week (group A: 12% mild, 82% moderate and 6% severe ; group B: 98% mild and 2% moderate) and 12th week (2% mild, 9% moderate and 89% severe ; group B: 99% mild and 1% moderate) in group A and B. Dapagliflozin-metformin is clinically more effective to treat glycemia in uncontrolled T2DM with metformin patients as compared to Glimepride-metformin combination. Furthermore, Dapagliflozin co-administered with metformin did not produce adverse effects