Abstract
BACKGROUND: Multiple daily insulin injection (MDI) is effective in preventing and slowing the progression of diabetic vascular complications in type 2 diabetes (T2D). However, MDI can impose various psychological and economic burdens. Some oral anti-diabetic agents can reduce such burdens and improve patient satisfaction in T2D subjects during MDI. Imeglimin is a newer anti-hyperglycemic agent with pharmacological action on both insulin secretion and resistance, and its efficacy has been demonstrated in phase III clinical trials. Considering imeglimin's action, this study examines whether reducing the number of insulin injections with imeglimin contributes to improved treatment satisfaction in subjects treated with MDI. METHODS: The study is a multicenter, prospective, randomized, open-label, parallel-group comparison trial. Thirty-six T2D subjects with glycated hemoglobin levels of 41-73 mmol/mol (6.0-8.9%) who had been treated with MDI for at least 12 weeks will be randomized to continue MDI or to receive an additional dose of imeglimin 1000 mg twice daily and discontinue bolus insulin for 12 weeks. At baseline and at the end of the study, questionnaires will be administered to assess treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire (DTSQ)) and eating behavior (Dutch Eating Behavior Questionnaire (DEBQ)); physical evaluation and biochemical analysis will be conducted; and adverse events will be recorded. The primary endpoint is the change in total DTSQ status version (DTSQs) score after 12 weeks. The secondary endpoints will consist of the mean changes in glycated hemoglobin, stratified analysis of the DTSQs, DTSQ change version (DTSQc), and DEBQ and changes in individual scores, physical examination, and other laboratory parameters. DISCUSSION: This will be the first randomized controlled trial comparing switching to long-acting insulin plus imeglimin therapy with continuing MDI in terms of efficacy on treatment satisfaction in T2D subjects treated with MDI. Asahikawa Medical University Research Ethics Committee (No. 11000290) has approved the protocol. The results will be disseminated in peer-reviewed journals and at scientific conferences. This study will provide new insights into the administration of imeglimin in management strategies for T2D subjects. TRIAL REGISTRATION: This protocol has been registered with the Japan Registry of Clinical Trials on 22 July 2024 [Identifier: jRCT1011240025, URL: https://jrct.niph.go.jp/latest-detail/jRCT1011240025 ] before the enrollment of the first participant.