Frequency and Severity of Hypoglycemia Under Conditions of Increased Hypoglycemic Risk with Insulin Efsitora Alfa Versus Insulin Glargine Treatment in Participants with Type 2 Diabetes.

IF 3.8 3区医学 Q2 Medicine Diabetes Therapy Pub Date : 2024-08-01 Epub Date: 2024-06-22 DOI:10.1007/s13300-024-01605-7

Tim Heise, Grit Andersen, Edward J Pratt, Jennifer Leohr, Tsuyoshi Fukuda, Qianqian Wang, Christof Kazda, Juliana M Bue-Valleskey, Richard M Bergenstal

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Abstract

Introduction: Insulin efsitora alfa (efsitora) is a basal insulin with a flat pharmacokinetic profile and long half-life, enabling weekly dosing. These attributes may provide stable glucose levels. This exploratory phase 1 study aimed to assess the hypoglycemic risk during experimental conditions that mimic situations encountered in daily life.

Methods: This was a single-site, open-label, two-period, fixed-sequence study in participants with type 2 diabetes (T2D) previously treated with basal insulin. The incidence, duration, and nadir glucose of hypoglycemia were assessed after treatment with efsitora versus insulin glargine (glargine) during three provocation conditions: 24-h prolonged fasting, prolonged fasting with exercise, and double dosing of study insulin.

Results: The 54 enrolled adults (BMI 21.8-39.7 kg/m², HbA1c 6.5-9.4%) achieved stable fasting glucose before undergoing provocation. Most hypoglycemic events were level 1 (≥ 54 to < 70 mg/dL) and resolved spontaneously or after oral glucose. The incidences of level 1 hypoglycemia for efsitora and glargine were not significantly different: for prolonged fasting, the incidences were 44.7 vs. 42.6% and the difference in proportion was 2.1% (95% CI: - 17.2, 21.4); for prolonged fasting with exercise, the corresponding values were 65.9 vs. 50.0% and 15.9% (- 3.0, 34.8); for double dosing, the corresponding values were 68.1 vs. 61.7% and 6.4% (- 12.8, 25.6). Level 2 hypoglycemia (< 54 mg/dL) was infrequent during both treatments and all provocations. No severe hypoglycemia was observed. Mean nadir glucose (range 62.8-66.3 mg/dL) and hypoglycemia duration (range 76.6-115.2 min) were also similar for the two treatments, depending on the provocation.

Conclusion: Overall, weekly efsitora did not increase the incidence, duration, or severity of hypoglycemia compared to daily glargine during provocation periods in patients with T2D.

Trial registration: ClinicalTrials.gov identifier NCT04957914.

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在低血糖风险增加的条件下，2 型糖尿病患者使用 Efsitora Alfa 胰岛素与 Glargine 胰岛素治疗低血糖的频率和严重程度。

简介胰岛素 efsitora alfa（efsitora）是一种基础胰岛素，药代动力学特征平缓，半衰期长，可每周给药一次。这些特性可提供稳定的血糖水平。这项探索性 1 期研究旨在模拟日常生活中遇到的情况，评估实验条件下的低血糖风险：这是一项单点、开放标签、两阶段、固定顺序的研究，研究对象为曾接受过基础胰岛素治疗的 2 型糖尿病（T2D）患者。在三种诱发条件下，评估了使用 efsitora 和格列奈胰岛素（格列奈）治疗后低血糖的发生率、持续时间和最低血糖：结果：结果：54 名参加研究的成年人（体重指数 21.8-39.7 kg/m2，HbA1c 6.5-9.4%）在接受诱导前的空腹血糖达到了稳定水平。大多数低血糖事件为 1 级（≥ 54 至结论：总体而言，在T2D患者的诱导期，与每日格列卫相比，每周一次的易适妥不会增加低血糖的发生率、持续时间或严重程度：试验注册：ClinicalTrials.gov 识别码 NCT04957914。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

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.