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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)
| Title: | 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) |
| Authors: | Nomoto, Hiroshi Browse this author →KAKEN DB | | Takahashi, Akihiro Browse this author | | Nakamura, Akinobu Browse this author | | Kurihara, Hiroyoshi Browse this author | | Takeuchi, Jun Browse this author | | Nagai, So Browse this author | | Taneda, Shinji Browse this author | | Miya, Aika Browse this author | | Kameda, Hiraku Browse this author | | Cho, Kyu Yong Browse this author | | Miyoshi, Hideaki Browse this author | | Atsumi, Tatsuya Browse this author →KAKEN DB |
| Keywords: | Metformin | | Dipeptidyl Peptidase 4 | | Diabetes Mellitus | | Type 2 |
| Issue Date: | Nov-2022 |
| Publisher: | BMJ Publishing Group |
| Journal Title: | Bmj open diabetes research and care |
| Volume: | 10 |
| Issue: | 6 |
| Start Page: | e002988 |
| Publisher DOI: | 10.1136/bmjdrc-2022-002988 |
| Abstract: | 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. |
| Type: | article |
| URI: | http://hdl.handle.net/2115/87798 |
| Appears in Collections: | 北海道大学病院 (Hokkaido University Hospital) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)
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