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)
Introduction Imeglimin 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...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-12-01
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| Series: | BMJ Open Diabetes Research & Care |
| Online Access: | https://drc.bmj.com/content/10/6/e002988.full |
| _version_ | 1797784230771556352 |
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| author | Kyu Yong Cho Tatsuya Atsumi Hiroshi Nomoto Jun Takeuchi So Nagai Akinobu Nakamura Hideaki Miyoshi Shinji Taneda Aika Miya Hiraku Kameda Akihiro Takahashi Hiroyoshi Kurihara |
| author_facet | Kyu Yong Cho Tatsuya Atsumi Hiroshi Nomoto Jun Takeuchi So Nagai Akinobu Nakamura Hideaki Miyoshi Shinji Taneda Aika Miya Hiraku Kameda Akihiro Takahashi Hiroyoshi Kurihara |
| author_sort | Kyu Yong Cho |
| collection | DOAJ |
| description | Introduction Imeglimin 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 methods This 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.Results This study will reveal new insights into the incorporation of imeglimin into the diabetes treatment strategy.Conclusions This 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.Trial registration number jRCT1011220005. |
| first_indexed | 2024-03-13T00:36:56Z |
| format | Article |
| id | doaj.art-97c4b01d827247b1bef0e3e070c8f9cd |
| institution | Directory Open Access Journal |
| issn | 2052-4897 |
| language | English |
| last_indexed | 2024-03-13T00:36:56Z |
| publishDate | 2022-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open Diabetes Research & Care |
| spelling | doaj.art-97c4b01d827247b1bef0e3e070c8f9cd2023-07-09T20:30:06ZengBMJ Publishing GroupBMJ Open Diabetes Research & Care2052-48972022-12-0110610.1136/bmjdrc-2022-002988Add-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)Kyu Yong Cho0Tatsuya Atsumi1Hiroshi Nomoto2Jun Takeuchi3So Nagai4Akinobu Nakamura5Hideaki Miyoshi6Shinji Taneda7Aika Miya8Hiraku Kameda9Akihiro Takahashi10Hiroyoshi Kurihara11Department of Rheumatology, Endocrinology, and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, JapanDepartment of Rheumatology, Endocrinology, and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, JapanDepartment of Rheumatology, Endocrinology, and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, JapanSapporo Diabetes and Thyroid Clinic, Sapporo, JapanDivision of Diabetes and Endocrinology, Department of Medicine, NTT East Corporation, Sapporo, JapanDepartment of Rheumatology, Endocrinology, and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, JapanDepartment of Rheumatology, Endocrinology, and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, JapanDiabetes Center, Manda Memorial Hospital, Sapporo, JapanDepartment of Rheumatology, Endocrinology, and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, JapanDepartment of Rheumatology, Endocrinology, and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, JapanDepartment of Rheumatology, Endocrinology, and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, JapanKurihara Clinic, Sapporo, JapanIntroduction Imeglimin 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 methods This 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.Results This study will reveal new insights into the incorporation of imeglimin into the diabetes treatment strategy.Conclusions This 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.Trial registration number jRCT1011220005.https://drc.bmj.com/content/10/6/e002988.full |
| spellingShingle | Kyu Yong Cho Tatsuya Atsumi Hiroshi Nomoto Jun Takeuchi So Nagai Akinobu Nakamura Hideaki Miyoshi Shinji Taneda Aika Miya Hiraku Kameda Akihiro Takahashi Hiroyoshi Kurihara 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) BMJ Open Diabetes Research & Care |
| 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) |
| title_full | 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_fullStr | 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_full_unstemmed | 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_short | 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_sort | 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 |
| url | https://drc.bmj.com/content/10/6/e002988.full |
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