1Head & Chief Diabetologist, MV Hospital Chennai, India.
2Endocrinologist, Fortis Med Centre, SCO-11, Chandigarh, India.
Diabetes Technol Ther. 2019 Aug;21(8):415-422. doi: 10.1089/dia.2019.0052.
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.
达格列净在印度的获批基于一项对照临床试验。该研究纳入了 2 型糖尿病（T2DM）印度患者，旨在确定达格列净在真实世界环境中的疗效。数据通过回顾性和前瞻性收集，随访 3 个月。主要终点为从基线至 3 个月和 6 个月时糖化血红蛋白（HbA1c）的平均变化。根据基线 HbA1c 和体重指数（BMI）对患者进行分层。采用双侧 95%置信区间和双侧检验，以 5%的显著水平分析终点。共有 98.1%（ = 1941/1978）名患者完成了研究，其中大多数为男性（57.5%），年龄<60 岁（77.8%）。与基线相比，HbA1c 显著降低（9.11%[1.44]降至 3 个月时的 8.11%[1.22]；Δ=1.00%[1.01]，6 个月时的 7.62%[1.04]；Δ=1.49%[1.18]，均<0.001）。根据基线 HbA1c 分层，HbA1c 降幅最大的是基线 HbA1c>10%的患者（3 个月时为 1.86%[1.32]，6 个月时为 2.80%[1.22]）。与基线相比，平均体重也显著下降（78.15 kg[13.48]降至 3 个月时的 77.01 kg[13.21]；Δ=1.14 kg[2.21]，6 个月时的 76.16 kg[13.09]；Δ=1.86 kg[3.04]，均<0.001），其中 BMI>30 kg/m 的患者体重下降最大（3 个月时为 1.60 kg[2.50]，6 个月时为 2.56 kg[3.50]）。收缩压/舒张压也有所改善。58 名（2.9%）发生≥1 次不良事件（AE）的患者中，9 名（0.5%）发生外阴阴道炎，4 名（0.2%）各发生 1 例真菌感染和尿路感染（UTI）。1 名患者发生 UTI 严重不良事件（SAE）。无患者因 AE 或 SAE 死亡或退出研究。达格列净可显著降低印度 T2DM 患者的 HbA1c 和体重。达格列净耐受性良好，未发现新的安全性信号。
