Abstract

Type 2 diabetes mellitus (T2DM) is an acquired form of diabetes often associated with being overweight and having an unhealthy lifestyle with respect to diet and exercise. It also shows a stronger association of onset with increasing age and is more common in certain ethnic groups such as South Asian and Afro-caribbeans. Although SGLT2 inhibitors have become an early recommended drug for patients with type 2 diabetes at a high risk of cardiovascular events, its effectiveness as a first-line medication for patients with newly diagnosed type 2 diabetes with no history of cardiovascular events is unclear. Dapagliflozin is a selective inhibitor of SGLT2 and acts to reduce hyperglycemia independently of insulin secretion or action. Dapagliflozin reduces systemic glycemic load by inhibiting this transporter, allowing some filtered glucose to pass into the urine for elimination. Material and Methods: This is a Prospective, randomized, Open-label was conducted in Type 2 DM patients attending the outpatient department of Medicine in Index Medical College and Hospital over a period of 2 years. All the Type 2 DM patients attending outpatient department (OPD) of Medicine were randomly divided into Dapagliflozin Group and Sitagliptin Group. The treatment drug (dapagliflozin 5.0 mg/day and sitagliptin 50 mg/day) was administered for 12 weeks. Follow-up visits were scheduled at the end of every month for 12 weeks for assessment, including measurement of weight and general and systemic examination. The following laboratory investigation was performed on sample of Type 2 DM patients before and after Dapagliflozin and Sitagliptin therapy. Adiponectin was estimated by DRG Diagnostic adiponectin Enzyme linked immune sorbent assay (ELISA) Kit. (B-Bridge International Inc., San Jose, CA, USA) with range of assay between 83-104 pg/Ml. Results: In our study body weight was 81.7 ± 8.3 kg in Dapagliflozin group and Sitagliptin group was 79.5 ± 7.10 kg. However, there were no significant differences in the changes in these metabolic parameters among the two study groups. Body mass index (kg/m2) was 24.9 ± 6.7 in Dapagliflozin group and Sitagliptin group was 24.3 ± 8.8. Hypertension was seen in 25 (17.9%) in Dapagliflozin group and Sitagliptin group was 60 (42.9). However, there were no significant differences between among two study groups. The change in serum adiponectin level from baseline to week 12 increased significantly only in the dapagliflozin group (P = 0.004) (Table 4). The mean ± SD change in Serum adiponectin at 12 weeks from baseline to 12 weeks were 0.75 ± 1.03 and 0.11 ± 0.05 in the dapagliflozin and sitagliptin groups, respectively. The subgroup analysis results for patients categorized according to their Lipid Profile at baseline into two groups. The changes in Lipid Profile from baseline to week 12 improved in two study groups. Conclusion: Dapagliflozin significantly reduced body weight and insulin AUC levels and improved serum adiponectin levels without inducing hypoglycemia. These results suggest that along with metformin and DPP-4 inhibitors, SGLT2 inhibitors could be a viable first-line treatment option for drug-naïve Japanese patients with type 2 diabetes because of their optimum glucose-lowering properties, ability to avoid hypoglycemia or weight gain, and tolerability over a wide range of ages.

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