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达格列净联合治疗与胰岛素剂量递增治疗对胰岛素控制不佳的 2 型糖尿病患者的疗效比较:DVI 研究。

Comparison betweeen dapagliflozin add-on therapy and insulin dose escalation in patients with uncontrolled type 2 diabetes treated with insulin: DVI study.

机构信息

Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.

Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.

出版信息

Diabetes Res Clin Pract. 2021 May;175:108843. doi: 10.1016/j.diabres.2021.108843. Epub 2021 Apr 30.

Abstract

AIM

To assess the efficacy and tolerability of adjunct therapy with a sodium-glucose cotransporter-2 inhibitor, dapagliflozin, compared with insulin escalation for patients with uncontrolled type 2 diabetes on current insulin therapy.

METHODS

A 12-month retrospective case-control study of patients with glycated hemoglobin (HbA1c) > 7% on insulin therapy. The study group received add-on therapy with dapagliflozin (10 mg once daily); the control group received titrated increases of their existing insulin dose by a mean of 21.6% from baseline. The primary endpoint was the change in HbA1c after 12 months. Secondary outcomes included changes in fasting plasma glucose, postprandial 2-h glucose levels, insulin requirements, and body weight.

RESULTS

After 12 months, the reduction in HbA1c was significantly greater in the dapagliflozin group than in the control group (from 8.9 ± 1.2% to 8.0 ± 1.0% vs 9.1 ± 1.2% to 8.7 ± 1.5%, respectively). Results for fasting plasma glucose and postprandial 2-h glucose were similar. Dapagliflozin therapy decreased systolic blood pressure (-4.7 mmHg) and body weight (-1.4 kg) significantly, whereas body weight increased by 0.6 kg in the control group. The dapagliflozin group showed significantly fewer hypoglycemic events than the control group (18.5% vs 32.6%, respectively). Daily insulin dose increased by 5.4 ± 6.1 U (21.6%) in the control group but decreased by 1.9 ± 5.3 U (-4.5%) in the dapagliflozin group (p < 0.001).

CONCLUSION

As an adjunct to insulin therapy, dapagliflozin therapy significantly improved glycemic control, with the clinical advantages of weight loss, insulin sparing, and less hypoglycemia.

摘要

目的

评估钠-葡萄糖共转运蛋白 2 抑制剂达格列净与胰岛素剂量递增治疗对正在接受胰岛素治疗的血糖控制不佳的 2 型糖尿病患者的疗效和耐受性。

方法

这是一项回顾性病例对照研究,纳入了 12 个月内接受胰岛素治疗且糖化血红蛋白(HbA1c)>7%的患者。研究组接受达格列净(10mg,每日一次)辅助治疗;对照组则根据基线胰岛素剂量平均增加 21.6%。主要终点是治疗 12 个月后 HbA1c 的变化。次要结局包括空腹血糖、餐后 2 小时血糖水平、胰岛素需求和体重的变化。

结果

治疗 12 个月后,达格列净组 HbA1c 的降幅显著大于对照组(从 8.9±1.2%降至 8.0±1.0%,而对照组从 9.1±1.2%降至 8.7±1.5%)。空腹血糖和餐后 2 小时血糖的结果相似。达格列净治疗可显著降低收缩压(-4.7mmHg)和体重(-1.4kg),而对照组体重增加 0.6kg。达格列净组低血糖事件发生率明显低于对照组(分别为 18.5%和 32.6%)。对照组胰岛素日剂量增加 5.4±6.1U(21.6%),而达格列净组则减少 1.9±5.3U(-4.5%)(p<0.001)。

结论

作为胰岛素治疗的辅助手段,达格列净治疗可显著改善血糖控制,且具有减重、节省胰岛素和减少低血糖的临床优势。

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