Clinical and Experimental Endocrinology, University of Leuven, Leuven, Belgium.
Endocrinology and Metabolic Diseases, Cantonal Hospital Olten, Olten, Switzerland.
Diabetes Obes Metab. 2020 Sep;22(9):1516-1526. doi: 10.1111/dom.14060. Epub 2020 May 22.
To investigate the long-term efficacy and safety of dapagliflozin as an adjunct to adjustable insulin in adults with type 1 diabetes (T1D) and inadequate glycaemic control.
Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes (DEPICT-2) was a placebo-controlled, double-blind, multicentre, phase III study of adults with T1D (HbA1c 7.5%-10.5%) randomized (1:1:1) to receive dapagliflozin 5, 10 mg, or placebo. The efficacy and safety of dapagliflozin over 52 weeks were exploratory endpoints in this extension to DEPICT-2.
Of 813 participants randomized, 88.2% completed the study. From baseline to 52 weeks, dapagliflozin 5 and 10 mg were associated with reduction in HbA1c (difference [95% CI] vs. placebo: -0.20% [-0.34, -0.06] and -0.25% [-0.38, -0.11], respectively) and adjusted mean percentage change in body weight (difference [95% CI] vs. placebo: -4.42% [-5.19, -3.64] and -4.86% [-5.63, -4.08], respectively). Serious adverse events were reported in the dapagliflozin 5, 10 mg, and placebo groups (32 [11.8%], 19 [7.0%] and 16 [5.9%], respectively). The proportion of hypoglycaemic events was similar across groups; severe hypoglycaemia was uncommon. More participants with events adjudicated as definite diabetic ketoacidosis (DKA) were in the dapagliflozin 5 and 10 mg groups versus placebo (11 [4.1%], 10 [3.7%] and 1 [0.4%], respectively); the majority of events were mild or moderate in severity and all were resolved with treatment.
Dapagliflozin led to long-term reductions in HbA1c and body weight in adults with T1D, but increased DKA risk compared with placebo.
评估达格列净作为辅助胰岛素治疗对血糖控制不佳的 1 型糖尿病（T1D）成人患者的长期疗效和安全性。
达格列净评估在血糖控制不佳的 1 型糖尿病患者中的疗效（DEPICT-2）是一项安慰剂对照、双盲、多中心、III 期研究，共纳入 813 名 T1D 患者（HbA1c 7.5%-10.5%），按 1:1:1 随机分组，分别接受达格列净 5mg、10mg 或安慰剂治疗。该研究为 DEPICT-2 的扩展研究，探索性终点为达格列净治疗 52 周的疗效和安全性。
813 名随机患者中，88.2%完成了研究。与安慰剂相比，达格列净 5mg 和 10mg 治疗 52 周可使 HbA1c 降低（差值[95%CI]：-0.20%[-0.34，-0.06]和-0.25%[-0.38，-0.11]），体重调整后平均百分比变化（差值[95%CI]：-4.42%[-5.19，-3.64]和-4.86%[-5.63，-4.08]）。达格列净 5mg、10mg 和安慰剂组分别有 32 例（11.8%）、19 例（7.0%）和 16 例（5.9%）发生严重不良事件。各组低血糖事件比例相似，严重低血糖少见。达格列净 5mg 和 10mg 组确诊糖尿病酮症酸中毒（DKA）事件多于安慰剂组（11[4.1%]、10[3.7%]和 1[0.4%]），大多数事件为轻或中度，所有事件均经治疗缓解。
与安慰剂相比，达格列净可长期降低 T1D 成人患者的 HbA1c 和体重，但增加了 DKA 风险。
