Safety and Effectiveness of Glargine 300 U/ml After Switching from Basal Insulins in Patients with Type 1 Diabetes: COMET-T Study.

IF 3.8 3区 医学 Q2 Medicine
Diabetes Therapy Pub Date : 2025-01-01 Epub Date: 2024-12-02 DOI:10.1007/s13300-024-01670-y
Stefan Gölz, Julia K Mader, Stefan Bilz, Julia Kenzler, Thomas Danne
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引用次数: 0

Abstract

Introduction: Appropriate glycemic control is paramount for people with type 1 diabetes (PwT1D) by the effective delivery of exogenous insulin. However, glycemic variability and the risk of severe hypoglycemia must be reliably controlled.

Methods: COMET-T is a prospective, multicenter, observational study conducted in Germany, Austria, and Switzerland during 2021-2022 to assess the effectiveness and safety of insulin glargine 300 U/ml (Gla-300) after switching from other basal insulins. Out of 135 PwT1D, data of 94 patients were analyzed. The primary endpoint was the change in time in range (TIR) approximately 12 and 24 weeks after switching to Gla-300. Secondary endpoints were: change in HbA1c, fasting plasma glucose (FPG), coefficient of variation (CV%) of plasma glucose, body weight (BW) and insulin dose.

Results: Patients had mean age of 48.6 ± 16.5 years, included 39.4% males and had 18.2 ± 15.5 years T1D duration. From baseline (54.3%), TIR changed at week 12 (mean change 0.3% [± 14.3]; p = 0.8383) and at week 24 (+ 4.5% [± 14.9], p = 0.078). At week 24, TIR significantly increased in patients with body mass index > 30 kg/m2 (8.4% [± 12.8] p = 0.0057) and patients who previously received insulin detemir (10.5%; [± 12.93]; p = 0.0005). At week 24, there was a significant reduction in the HbA1c value (8.1 ± 0.6% vs. 7.7 ± 0.9%; p < 0.001), a reduction in the CV% of plasma glucose (36.1 ± 12.4% vs. 32.8 ± 9.6%, p = 0.056), and increase in bolus insulin dose (26.5 ± 16.3 vs. 27.9 ± 16.6 U/day; p = 0.042). FPG, BW, and basal insulin doses were not significantly changed.

Conclusions: Although switching to Gla-300 in poorly controlled PwT1D did not significantly reduce TIR, it significantly decreased HbA1c values and glycemic variability without changes in BW and basal insulin dose.

甘精300 U/ml在1型糖尿病患者从基础胰岛素转换后的安全性和有效性:COMET-T研究
适当的血糖控制是1型糖尿病(PwT1D)患者通过外源性胰岛素的有效输送至关重要。然而,血糖变异性和严重低血糖的风险必须得到可靠的控制。方法:COMET-T是一项前瞻性、多中心、观察性研究,于2021-2022年在德国、奥地利和瑞士开展,旨在评估从其他基础胰岛素转换为300 U/ml甘精胰岛素(Gla-300)后的有效性和安全性。在135例PwT1D中,分析了94例患者的数据。主要终点是切换到Gla-300后大约12周和24周的范围内时间(TIR)变化。次要终点:HbA1c、空腹血糖(FPG)、血糖变异系数(CV%)、体重(BW)和胰岛素剂量的变化。结果:患者平均年龄48.6±16.5岁,其中男性39.4%,T1D病程18.2±15.5年。从基线(54.3%)开始,TIR在第12周发生变化(平均变化0.3%[±14.3];p = 0.8383)和24周(+ 4.5%±14.9,p = 0.078)。在第24周,体重指数为bbb30 kg/m2的患者的TIR显著升高(8.4%[±12.8]p = 0.0057),先前接受过地铁胰岛素的患者的TIR显著升高(10.5%;(±12.93);p = 0.0005)。在第24周,HbA1c值显著降低(8.1±0.6% vs. 7.7±0.9%;p结论:虽然控制不良的PwT1D患者改用Gla-300并没有显著降低TIR,但它显著降低了HbA1c值和血糖变异性,而没有改变体重和基础胰岛素剂量。
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来源期刊
Diabetes Therapy
Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism
CiteScore
6.90
自引率
7.90%
发文量
130
审稿时长
6 weeks
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.
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