Efficacy and Safety of Switching from Sitagliptin to Ipragliflozin in Obese Japanese Patients with Type 2 Diabetes Mellitus: A Single-Arm Multicenter Interventional Study.

IF 2.9 3区 医学 Q2 PHARMACOLOGY & PHARMACY Clinical Drug Investigation Pub Date : 2023-12-01 Epub Date: 2023-11-07 DOI:10.1007/s40261-023-01317-z
Kentaro Watanabe, Susumu Yamaguchi, Yoshinori Kosakai, Tetsuya Ioji, Hisamitsu Ishihara
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Abstract

Background: Dipeptidyl peptidase-4 inhibitors have limited efficacy in improving glycemic control for obese Japanese patients with type 2 diabetes mellitus. Sodium-glucose co-transporter 2 inhibitors are recommended for use in patients with type 2 diabetes with obesity. Nevertheless, there has been no previously published study on the effect of switching from dipeptidyl peptidase-4 inhibitors to sodium-glucose co-transporter 2 inhibitors on the systemic and organic effects in obese Japanese patients with type 2 diabetes.

Objectives: We evaluated the efficacy and safety of switching from sitagliptin to ipragliflozin for 24 weeks in obese Japanese patients with inadequately controlled type 2 diabetes.

Methods: Fifty-one obese patients with type 2 diabetes (body mass index > 25 kg/m2) treated with sitagliptin (50 mg) and metformin but with inadequate glycemic control (glycosylated hemoglobin [HbA1c] > 7.5% and < 9.0%) were enrolled. After a 4-week observation period, sitagliptin was switched to ipragliflozin (50 mg) for 24 weeks. The primary outcome was the change in HbA1c from baseline to the end of treatment. The secondary outcomes were changes in clinical characteristics and other biochemical variables.

Results: Fifty-one patients with an average HbA1c of 8.37 ± 0.48% and body mass index of 28.8 ± 3.8 kg/m2 were enrolled. Fifty patients completed the study, one patient stopped ipragliflozin at 4 weeks because of the development of hyperosmolar hyperglycemic syndrome. No significant change in HbA1c from baseline to the end of treatment was observed (- 0.02 ± 0.75%). However, fasting plasma glucose was reduced (- 16.2 ± 28.4 mg/dL, p < 0.001), and biochemical variables associated with insulin resistance, oxidative stress, and hepatic and renal functions showed significant improvements. No severe adverse effects were observed, except in the one aforementioned case.

Conclusions: Switching from sitagliptin to ipragliflozin did not alter HbA1c in obese patients with type 2 diabetes, while improving parameters related to organ homeostasis. These data provide novel information useful for selecting oral anti-diabetic agents for patients with type 2 diabetes with obesity, a risk factor for developing various complications of diabetes.

Clinical trial registration: Japan Registry of Clinical Trials identifier: jRCT#031190022.

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日本肥胖2型糖尿病患者从西他列汀转为依普利洛嗪的疗效和安全性:一项单臂多中心介入研究。
背景:二肽基肽酶-4抑制剂在改善肥胖日本2型糖尿病患者血糖控制方面的疗效有限。建议将钠-葡萄糖共转运蛋白2抑制剂用于2型糖尿病合并肥胖的患者。尽管如此,之前还没有发表过关于从二肽基肽酶-4抑制剂转换为钠-葡萄糖共转运蛋白2抑制剂对肥胖的日本2型糖尿病患者的全身和器质性影响的研究。目的:我们评估了在肥胖的日本2型糖尿病患者中,从西他列汀转为异丙列嗪治疗24周的疗效和安全性。方法:51名肥胖2型糖尿病患者(体重指数>25 kg/m2)接受西格列汀(50 mg)和二甲双胍治疗,但血糖控制不足(糖化血红蛋白[HbA1c]结果:51例患者的平均HbA1c为8.37±0.48%,体重指数为28.8±3.8kg/m2。50名患者完成了这项研究,其中一名患者在4周时因高渗性高血糖综合征而停止服用异丙列嗪。从基线到治疗结束,HbA1c没有观察到显著变化(-0.02±0.75%)。然而,空腹血糖降低(-16.2±28.4 mg/dL,p<0.001),与胰岛素抵抗、氧化应激以及肝肾功能相关的生化变量显示出显著改善。除上述一例外,未观察到严重不良反应。结论:在2型糖尿病肥胖患者中,从西他列汀转为异丙列嗪不会改变HbA1c,同时改善了与器官稳态相关的参数。这些数据提供了新的信息,有助于为患有肥胖的2型糖尿病患者选择口服抗糖尿病药物,肥胖是糖尿病各种并发症的风险因素。临床试验注册:日本临床试验注册处标识符:jRCT#03119022。
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来源期刊
CiteScore
5.90
自引率
3.10%
发文量
108
审稿时长
6-12 weeks
期刊介绍: Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.
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