Use of Dapagliflozin in the Management of Type 2 Diabetes Mellitus: A Real-World Evidence Study in Indian Patients (FOREFRONT).

Dapagliflozin is approved in India based on a controlled clinical study. This study included type 2 diabetes mellitus (T2DM) Indian patients to determine effectiveness of dapagliflozin in the real-world setup. Data were collected retrospectively and prospectively for 3 months. Primary endpoint was mean change in glycated hemoglobin (HbA1c) from baseline to months 3 and 6. Patients were stratified by baseline HbA1c and body mass index (BMI). Paired -test or Wilcoxon signed-rank test at 5% level of significance with two-sided 95% confidence intervals analyzed endpoints. Total 98.1% ( = 1941/1978) patients completed the study, majority of them were men (57.5%), <60 years (77.8%). Mean (standard deviation [SD]) HbA1c decreased significantly from baseline (9.11% [1.44]) to month 3 (8.11% [1.22]; Δ = 1.00% [1.01]) and month 6 (7.62% [1.04]; Δ = 1.49% [1.18]),  < 0.001. Per baseline HbA1c stratification, the largest mean (SD) decrease in HbA1c was in patients with baseline HbA1c >10% (1.86% [1.32] at month 3; 2.80% [1.22] at month 6). Decrease in mean body weight was significant from baseline (78.15 kg [13.48]) to month 3 (77.01 kg [13.21]; Δ = 1.14 kg [2.21]) and month 6 (76.16 kg [13.09]; Δ = 1.86 kg [3.04]),  < 0.001, with maximum weight loss in patients with BMI >30 kg/m (1.60 kg [2.50] and 2.56 kg [3.50] at months 3 and 6, respectively). Systolic/diastolic blood pressure also improved. Of the 58 (2.9%) patients having ≥1 adverse event (AE), 9 (0.5%) had vulvovaginitis and 4 (0.2%) each had fungal infection and urinary tract infection (UTI). One patient had a serious AE (SAE) of UTI. No patients died or discontinued the study because of AEs or SAEs. Dapagliflozin significantly decreased HbA1c and body weight in Indian T2DM patients. Dapagliflozin was well tolerated and no new safety signals were detected.