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Efficacy and safety of adding ipragliflozin to insulin in Japanese patients with type 1 diabetes mellitus: a retrospective study
Endocrine Journal ( IF 1.3 ) Pub Date : 2021-12-28 , DOI: 10.1507/endocrj.ej21-0161
Masashi Shimoda 1 , Akiko Mashiko 1 , Yukino Katakura 1 , Junpei Sanada 1 , Yoshiro Fushimi 1 , Atsushi Obata 1 , Tomohiko Kimura 1 , Kenji Kohara 1 , Fuminori Tatsumi 1 , Shuhei Nakanishi 1 , Tomoatsu Mune 1 , Kohei Kaku 2 , Hideaki Kaneto 1
Affiliation  

Advances in insulin preparations and administration methods have produced a gradual improvement in glycemic control in patients with type 1 diabetes mellitus (DM). Nevertheless, glycated hemoglobin (HbA1c) levels in patients with type 1 DM are still poor compared to those in patients with type 2 DM. Here, we sought to assess the efficacy and safety of the sodium-glucose cotransporter 2 (SGLT2) inhibitor ipragliflozin (IPRA) in patients with type 1 DM. This study was retrospectively conducted with data from type 1 DM patients who had a history of IPRA therapy. The primary endpoint was HbA1c level at 24 weeks. The baseline characteristics of a total of 12 subjects were as follows: age, 50.1 ± 13.2 years; diabetes duration, 17.3 ± 10.5 years; body mass index (BMI), 22.9 ± 2.1 kg/m2; HbA1c, 8.8 ± 1.3%; and daily insulin dose, 0.60 ± 0.21 units/kg. IPRA decreased HbA1c levels to 8.2 ± 1.2% (p < 0.05) and reduced insulin dose to 0.52 ± 0.17 units/kg (p < 0.01) after 24 weeks. HbA1c value was particularly reduced in subjects with preserved C-peptide index. IPRA significantly reduced body weight by –1.4 ± 1.4 kg (p < 0.01) 16 weeks after starting treatment, with no further weight loss after 24 weeks. There were no instances of diabetic ketoacidosis or severe hypoglycemia. IPRA exerted beneficial effects on glycemic control without any severe adverse effects, and should be safe and effective when used in patients with type 1 DM with understanding of correspondence in sick day.



中文翻译:

日本 1 型糖尿病患者在胰岛素中添加 ipragliflozin 的疗效和安全性:一项回顾性研究

胰岛素制剂和给药方法的进步使 1 型糖尿病 (DM) 患者的血糖控制逐渐改善。尽管如此,与 2 型糖尿病患者相比,1 型糖尿病患者的糖化血红蛋白 (HbA1c) 水平仍然较差。在这里,我们试图评估钠-葡萄糖协同转运蛋白 2 (SGLT2) 抑制剂 ipragliflozin (IPRA) 在 1 型 DM 患者中的疗效和安全性。这项研究是回顾性地使用来自有 IPRA 治疗史的 1 型 DM 患者的数据进行的。主要终点是 24 周时的 HbA1c 水平。共有 12 名受试者的基线特征如下:年龄,50.1 ± 13.2 岁;糖尿病病程,17.3 ± 10.5 年;体重指数 (BMI),22.9 ± 2.1 kg/m 2; HbA1c,8.8 ± 1.3%;和每日胰岛素剂量,0.60 ± 0.21 单位/公斤。24 周后,IPRA 将 HbA1c 水平降低至 8.2 ± 1.2% ( p < 0.05),并将胰岛素剂量降低至 0.52 ± 0.17 单位/kg ( p < 0.01)。在保留 C 肽指数的受试者中,HbA1c 值尤其降低。IPRA 在开始治疗 16 周后体重显着降低 –1.4 ± 1.4 kg ( p < 0.01),24 周后体重没有进一步减轻。没有糖尿病酮症酸中毒或严重低血糖的病例。IPRA 对血糖控制发挥了有益作用,没有任何严重的不良反应,在了解病假对应的 1 型 DM 患者中使用时应该是安全有效的。

更新日期:2021-12-27
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