Add-on imeglimin versus metformin dose escalation regarding glycemic control in patients with type 2 diabetes treated with a dipeptidyl peptidase-4 inhibitor plus low-dose metformin : study protocol for a multicenter, prospective, randomized, open-label, parallel-group comparison study (MEGMI study)

Nomoto, Hiroshi; Takahashi, Akihiro; Nakamura, Akinobu; Kurihara, Hiroyoshi; Takeuchi, Jun; Nagai, So; Taneda, Shinji; Miya, Aika; Kameda, Hiraku; Cho, Kyu Yong; Miyoshi, Hideaki; Atsumi, Tatsuya

Add-on imeglimin versus metformin dose escalation regarding glycemic control in patients with type 2 diabetes treated with a dipeptidyl peptidase-4 inhibitor plus low-dose metformin : study protocol for a multicenter, prospective, randomized, open-label, parallel-group comparison study (MEGMI study)

Nomoto, Hiroshi; Takahashi, Akihiro; Nakamura, Akinobu et al.

Bmj open diabetes research and care, 2022, 10(6), e002988

Permalink : https://hdl.handle.net/2115/87798

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アクセス権	open access
URI	https://hdl.handle.net/2115/87798
タイトル	Add-on imeglimin versus metformin dose escalation regarding glycemic control in patients with type 2 diabetes treated with a dipeptidyl peptidase-4 inhibitor plus low-dose metformin : study protocol for a multicenter, prospective, randomized, open-label, parallel-group comparison study (MEGMI study)
著者	Nomoto, Hiroshi ; Takahashi, Akihiro ; Nakamura, Akinobu ; Kurihara, Hiroyoshi ; Takeuchi, Jun ; Nagai, So ; Taneda, Shinji ; Miya, Aika ; Kameda, Hiraku ; Cho, Kyu Yong ; Miyoshi, Hideaki ; Atsumi, Tatsuya
e-Rad_Researcher 50862330 著者名 Nomoto, Hiroshi
著者名 Takahashi, Akihiro
著者名 Nakamura, Akinobu
著者名 Kurihara, Hiroyoshi
著者名 Takeuchi, Jun
著者名 Nagai, So
著者名 Taneda, Shinji
著者名 Miya, Aika
著者名 Kameda, Hiraku
著者名 Cho, Kyu Yong
著者名 Miyoshi, Hideaki
e-Rad_Researcher 20301905 著者名 Atsumi, Tatsuya
言語	英語
キーワード	Metformin
	Dipeptidyl Peptidase 4
	Diabetes Mellitus
	Type 2
発行日	2022-11
出版者	BMJ Publishing Group
収録物名	Bmj open diabetes research and care
巻(号)	10(6)
ページ	e002988
抄録	IntroductionImeglimin is a novel anti-hyperglycemic drug that improves both insulin resistance and insulin secretion. The effects of imeglimin on glycemic control were confirmed in phase III clinical trials, but little is known about its effectiveness in daily clinical practice settings, especially compared with metformin. Therefore, we aim to clarify the efficacy of imeglimin in patients with type 2 diabetes (T2D) being treated with a dipeptidyl peptidase-4 (DPP-4) inhibitor plus low-dose metformin.Research design and methodsThis is a multicenter, randomized, prospective, open-label, parallel-group trial. Seventy participants with T2D treated with a DPP-4 inhibitor plus metformin (500-1000 mg/day) for more than 12 weeks and a glycated hemoglobin (HbA1c) level of 52-85 mmol/mol (7.0%-9.9%) will be randomized to receive add-on imeglimin 1000 mg two times per day or metformin dose escalation for 24 weeks. Biochemical analyses and physical assessments will be performed at baseline and at the end of the study, and adverse events will be recorded. The primary endpoint is the change in HbA1c after 24 weeks. The secondary endpoints comprise the changes in blood pressure, pulse rate, body weight, abdominal circumference, and other laboratory parameters; the relationship between improvements of biological parameters including glycemic control and patient background characteristics; and side effects.ResultsThis study will reveal new insights into the incorporation of imeglimin into the diabetes treatment strategy.ConclusionsThis will be the first randomized controlled trial to compare the efficacy of adding imeglimin versus metformin dose escalation on glycemic control in patients with T2D.
資源タイプ	学術雑誌論文
出版タイプ	Version of Record
関連情報 (isIdenticalTo)	出版社版DOI https://doi.org/10.1136/bmjdrc-2022-002988