Vijay Viswanathan1, K P Singh2. 1. 1Head & Chief Diabetologist, MV Hospital Chennai, India. 2. 2Endocrinologist, Fortis Med Centre, SCO-11, Chandigarh, India.
Abstract
Background: 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. Methods: 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 t-test or Wilcoxon signed-rank test at 5% level of significance with two-sided 95% confidence intervals analyzed endpoints. Results: Total 98.1% (n = 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]), P < 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]), P < 0.001, with maximum weight loss in patients with BMI >30 kg/m2 (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. Conclusion: Dapagliflozin significantly decreased HbA1c and body weight in Indian T2DM patients. Dapagliflozin was well tolerated and no new safety signals were detected.
Background: 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. Methods: 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 t-test or Wilcoxon signed-rank test at 5% level of significance with two-sided 95% confidence intervals analyzed endpoints. Results: Total 98.1% (n = 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]), P < 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]), P < 0.001, with maximum weight loss in patients with BMI >30 kg/m2 (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. Conclusion:Dapagliflozin significantly decreased HbA1c and body weight in Indian T2DM patients. Dapagliflozin was well tolerated and no new safety signals were detected.