300 U/mL甘精胰岛素在基础胰岛素控制的2型糖尿病患者中的有效性和安全性:26周的单臂介入性ARTEMIS-DM研究

IF 2.8 3区医学 Q3 ENDOCRINOLOGY & METABOLISM Diabetes Therapy Pub Date : 2022-07-01 Epub Date: 2022-06-17 DOI:10.1007/s13300-022-01271-7

Bipin Sethi, Khalid Al-Rubeaan, Mustafa Unubol, Maria A Mabunay, Baptiste Berthou, Valerie Pilorget, Shireene R Vethakkan, Gustavo Frechtel

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引用次数: 0

摘要

简介：对于使用基础胰岛素（BI）未获控制的 2 型糖尿病（T2DM）患者，改用格列美脲胰岛素 300 U/mL（Gla-300）的有效性和安全性已在北美和西欧人群中得到证实；然而，来自其他地区不同种族的数据却很有限。ARTEMIS-DM 研究旨在评估 Gla-300 对亚洲、拉丁美洲和中东非洲使用基础胰岛素未得到控制的 T2DM 患者的疗效和安全性：ARTEMIS-DM 是一项为期 26 周的前瞻性、干预性、单臂 IV 期研究（NCT03760991）。之前服用 BI 的 T2DM 患者（糖化血红蛋白 [HbA1c] 7.5-10%）转为服用 Gla-300。主要终点是 HbA1c 从基线到 26 周的变化。主要次要终点是 HbA1c（第 12 周）、空腹血浆葡萄糖 (FPG)、自我监测血浆葡萄糖 (SMPG) 和 BI 剂量从基线到第 26 周的变化。此外，还对 Gla-300 的安全性和耐受性进行了评估：共纳入 372 名参与者（50% 为男性），平均（标准差 [SD]）年龄为 60.9 (10.0)岁，糖尿病病程为 13.11 (7.48)年，基线 HbA1c 为 8.67 (0.77)% (71.22 [8.44] mmol/mol)。共有 222 人（59.7%）使用格列美脲胰岛素 100 U/mL，107 人（28.8%）使用中性原研胰岛素。第 26 周时，平均 HbA1c（- 0.82%；主要终点）、FPG 和 SMPG 水平均有临床显著降低。通过预先定义的滴定算法，Gla-300 的平均剂量从基线时的 27.48 U（0.35 U/kg）增加到第 26 周时的 39.01 U（0.50 U/kg）。20.4%的参与者发生了低血糖事件；1名（0.3%）参与者发生了严重低血糖事件：结论：对于既往接受 BI 治疗但血糖未得到控制的 T2DM 患者，改用 Gla-300 并在算法指导下进行最佳滴定可改善血糖控制，且在多个地区低血糖发生率较低：Gov 标识符：NCT03760991。

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Efficacy and Safety of Insulin Glargine 300 U/mL in People with Type 2 Diabetes Uncontrolled on Basal Insulin: The 26-Week Interventional, Single-Arm ARTEMIS-DM Study.

Introduction: The efficacy and safety of switching to insulin glargine 300 U/mL (Gla-300) in type 2 diabetes mellitus (T2DM) uncontrolled on basal insulin (BI) has been demonstrated in the North American and Western European populations; however, there is limited data from other geographical regions with different ethnicities. The ARTEMIS-DM study aimed to evaluate the efficacy and safety of Gla-300 in people with T2DM uncontrolled on BI from Asia, Latin America and Middle East Africa.

Methods: The ARTEMIS-DM was a 26-week, prospective, interventional, single-arm, phase IV study (NCT03760991). Adults with T2DM previously uncontrolled (glycated haemoglobin [HbA_1c] 7.5-10%) on BI were switched to Gla-300. The primary endpoint was change in HbA_1c from baseline to 26 weeks. Key secondary endpoints were changes in HbA_1c (week 12), fasting plasma glucose (FPG), self-monitored plasma glucose (SMPG) and BI dose from baseline to week 26. The safety and tolerability of Gla-300 were also assessed.

Results: A total of 372 (50% male) participants were included, with mean (standard deviation [SD]) age 60.9 (10.0) years, duration of diabetes 13.11 (7.48) years and baseline HbA_1c 8.67 (0.77)% (71.22 [8.44] mmol/mol). A total of 222 (59.7%) participants were using insulin glargine 100 U/mL and 107 (28.8%) were using neutral protamine Hagedorn insulin as previous BI. There were clinically significant reductions in mean HbA_1c (- 0.82%; primary endpoint), FPG and SMPG levels at week 26. With a pre-defined titration algorithm, mean Gla-300 dose increased from 27.48 U (0.35 U/kg) at baseline to 39.01 U (0.50 U/kg) at week 26. Hypoglycaemia events occurred in 20.4% of the participants; 1 (0.3%) participant had a severe hypoglycaemia event.

Conclusion: In people with T2DM uncontrolled on previous BI, switching to Gla-300 with optimal titration guided by an algorithm was associated with improved glycaemic control and low incidence of hypoglycaemia across multiple geographic regions.

Clinicaltrials:

Gov identifier: NCT03760991.

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来源期刊

Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism

自引率

7.90%

发文量

130

期刊介绍： Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.