Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes: The DEPICT-1 52-Week Study
Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes: The DEPICT-1 52-Week Study
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DOI：
10.2337/dc18-1087
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发表时间：
2018-12-01
期刊：
影响因子：
16.2
通讯作者：
Langkilde, Anna Maria
中科院分区：
文献类型：
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作者：
Dandona, Paresh;Mathieu, Chantal;Langkilde, Anna Maria
研究设计和方法DEPICT-1（达格列净在血糖控制不佳的1型糖尿病患者中的评价）是一项随机（1：1：1）、双盲、安慰剂对照的3期研究，在1型糖尿病患者（HbA（1c）7.5-10.5% [58-91 mmol/mol]）中评价达格列净5 mg和10 mg（NCT 02268214）。本文报告了52周研究的结果，包括24周短期和28周扩展期。在833名随机进入研究的患者中，708名（85%）完成了52周研究。在52周内，达格列净5 mg和10 mg导致HbA（1c）临床显著降低（与安慰剂相比的差异[95% CI]为-0.33% [-0.49，-0.17] [-3.6 mmol/mol（-5.4，-1.9）]和-0.36% [-0.53，-0.20] [-3.9 mmol/mol（分别为-5.8，-2.2）]）和体重（与安慰剂组的差异[95% CI]分别为-2.95% [-3.83，-2.06]和-4.54% [-5.40，-3.66]）。达格列净5 mg、10 mg和安慰剂组分别有13.4%、13.5%和11.5%的患者报告了严重不良事件。尽管治疗组间低血糖事件相当，但达格列净组中更多患者发生被裁定为明确的糖尿病酮症酸中毒的事件（DKA;达格列净5 mg、10 mg和安慰剂组分别为4.0%、3.4%和1.9%）。结论在52周内，达格列净改善了1型糖尿病患者的血糖控制和体重减轻，同时增加DKA的风险。
OBJECTIVEThis study evaluated the long-term safety and efficacy of dapagliflozin as an adjunct to adjustable insulin in patients with type 1 diabetes and inadequate glycemic control.RESEARCH DESIGN AND METHODSDEPICT-1 (Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes) was a randomized (1:1:1), double-blind,placebo-controlled phase 3 study of dapagliflozin 5 mg and 10 mg in patients with type 1 diabetes (HbA(1c) 7.5-10.5% [58-91 mmol/mol]) (NCT02268214). The results of the 52-week study, consisting of the 24-week short-term and 28-week extension period, are reported here.RESULTSOf the 833 patients randomized into the study, 708 (85%) completed the 52-week study. Over 52 weeks, dapagliflozin 5 mg and 10 mg led to clinically significant reductions in HbA(1c) (difference vs. placebo [95% CI] -0.33% [-0.49, -0.17] [-3.6 mmol/mol (-5.4, -1.9)] and -0.36% [-0.53, -0.20] [-3.9 mmol/mol (-5.8, -2.2)], respectively) and body weight (difference vs. placebo [95% CI] -2.95% [-3.83, -2.06] and -4.54% [-5.40, -3.66], respectively). Serious adverse events were reported in 13.4%, 13.5%, and 11.5% of patients in the dapagliflozin 5 mg, 10 mg, and placebo groups, respectively. Although hypoglycemia events were comparable across treatment groups, more patients in the dapagliflozin groups had events adjudicated as definite diabetic ketoacidosis (DKA; 4.0%, 3.4%, and 1.9% in dapagliflozin 5 mg, 10 mg, and placebo groups, respectively).CONCLUSIONSOver 52 weeks, dapagliflozin led to improvements in glycemic control and weight loss in patients with type 1 diabetes, while increasing the risk of DKA.