A Prospective Analysis of the Efficacy and Safety of Sodium Glucose Cotransporter 2 Inhibitors: Real World Evidence from Clinical Practice in India.

BACKGROUND AND AIM The number of patients with type 2 diabetes (T2DM) is increasing. Most patients with T2DM are uncontrolled and fail to achieve their target Hba1c. In recent years, newer agents such as SGLT2 inhibitors (SGLT2i) have been approved for clinical use. Though data from clinical trials and sub set analysis of Indian patients in global studies are promising, real world evidence from standard clinical practice in India is lacking. The aim of this study was to analyze the metabolic parameters in patients with T2DM on SGLT2i in real world clinical practice. MATERIAL AND METHODS This was a prospective, longitudinal study of 100 patients with uncontrolled T2DM attending the outpatient of a specialized diabetes hospital. Their metabolic parameters were evaluated at baseline and after 3 months of follow up. They were categorized based on their baseline anti diabetic medications into four groups (25 in each).The groups were as follows: metformin plus sulfonylurea, metformin plus DPP4 inhibitor, triple drug regimen with metformin plus DPP4 inhibitor plus sulfonylurea, and patients on insulin and on triple drug therapy with metformin plus sulfonylurea plus DPP4 inhibitor. Patients in each group were initiated with an SGLT2i. Descriptive statistical analysis was carried out using Microsoft excel. T test was used to calculate the p value at 5 % level of significance. RESULTS The mean age of the subjects in the study population was 53.20±12.1 years and the duration of diabetes was 13.1±7.26 years. The mean Hba1c reduction and weight reduction observed was 1.02±0.24% and 2.64±1.27 kg respectively. Genital pruritis was reported in 4% of the patients. There was a 16.6% reduction in the daily insulin requirement at follow up when compared to baseline. No other side effects were observed. The reductions in Hba1c and weight were statistically significant (p<0.05) across all groups. CONCLUSIONS This study demonstrates that when SGLT2i are added at any stage of the disease spectrum with any of the preexisting therapeutic agents for patients with uncontrolled T2DM, there is an improvement in glycemic control and body weight, with minimal side effects. The real world study data on Indian patients appears to be promising.