Rationale and Design of the Study to Investigate the Metabolic Action of Imeglimin on Patients with Type 2 Diabetes Mellitus (SISIMAI).

IF 3.8 3区 医学 Q2 Medicine
Tsubasa Tajima, Hideyoshi Kaga, Naoaki Ito, Toshiki Kogai, Hitoshi Naito, Saori Kakehi, Satoshi Kadowaki, Yuya Nishida, Ryuzo Kawamori, Yoshifumi Tamura, Hirotaka Watada
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引用次数: 0

Abstract

Introduction: Imeglimin is a first-in-class, novel, oral glucose-lowering agent for the treatment of type 2 diabetes mellitus. The efficacy and safety of imeglimin as an antidiabetic agent have been investigated in clinical trials. However, its metabolic effects in humans have not yet been fully elucidated.

Methods: The Study to InveStIgate the Metabolic Action of Imeglimin on patients with type 2 diabetes mellitus (SISIMAI) is a single-arm intervention study. In this study, we have recruited 25 patients with type 2 diabetes to receive 2000 mg/day imeglimin for 20 weeks. We perform a 75-g oral glucose tolerance test (OGTT) with double-glucose tracers, a two-step hyperinsulinemic-euglycemic clamp with glucose tracer, ectopic fat measurement by proton magnetic resonance spectroscopy, visceral/subcutaneous fat area measurement by magnetic resonance imaging, muscle biopsy, and evaluation of fitness level by cycle ergometer before and after imeglimin administration.

Planned outcomes: The primary outcome is the change in area under the curve of glucose levels during the OGTT after 20 weeks of imeglimin treatment. We also calculate the endogenous glucose production, rate of oral glucose appearance, and rate of glucose disappearance from the data during the 75-g OGTT and compare them between pre- and post-treatment. Additionally, we will compare other parameters, such as the changes in tissue-specific insulin sensitivity, ectopic fat accumulation, visceral/subcutaneous fat area accumulation, and fitness level between each point. This is the first study to investigate the organ-specific metabolic action of imeglimin in patients with type 2 diabetes mellitus using the 75-g OGTT with the double tracer method. The results of this study are expected to provide useful information for drug selection based on the pathophysiology of individual patients with type 2 diabetes mellitus.

Trial registration: jRCTs031210600.

调查伊麦格列明对 2 型糖尿病患者代谢作用的研究(SISIMAI)的原理和设计。
简介伊迈格列明是治疗 2 型糖尿病的第一类新型口服降糖药。伊迈格列明作为一种抗糖尿病药物的有效性和安全性已在临床试验中得到研究。然而,它对人体代谢的影响尚未完全阐明:伊迈格列明对 2 型糖尿病患者代谢作用的研究(SISIMAI)是一项单臂干预研究。在这项研究中,我们招募了 25 名 2 型糖尿病患者,让他们在 20 周内每天服用 2000 毫克伊麦格列明。在服用伊麦格列明前后,我们进行了使用双葡萄糖示踪剂的 75 克口服葡萄糖耐量试验(OGTT)、使用葡萄糖示踪剂的两步高胰岛素血糖钳夹、质子磁共振光谱异位脂肪测量、磁共振成像内脏/皮下脂肪面积测量、肌肉活检,以及使用自行车测力计评估体能水平:主要结果是伊麦格列明治疗 20 周后 OGTT 血糖水平曲线下面积的变化。我们还将根据 75 克 OGTT 的数据计算内源性葡萄糖生成量、口服葡萄糖出现率和葡萄糖消失率,并在治疗前和治疗后进行比较。此外,我们还将比较其他参数,如各点之间组织特异性胰岛素敏感性、异位脂肪堆积、内脏/皮下脂肪面积堆积和体能水平的变化。这是首次使用双示踪法 75 克 OGTT 研究伊迈格列明对 2 型糖尿病患者器官特异性代谢作用的研究。这项研究的结果有望为根据2型糖尿病患者的病理生理学选择药物提供有用的信息。
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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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