Evidence map›Paper›PMID 41345697›Full record

ArticleTrials2025

Comparison of the effect on treatment satisfaction of switching from multiple insulin injection therapy to additional administration of imeglimin in subjects with type 2 diabetes (MEGMI-TS): study protocol for a multicenter, prospective, randomized, open-label, parallel-group comparison trial.

Hiroya Kitsunai, Takashi Nanbu, Fumika Maruyama, Tasuku Sato, Yuri Takiyama, Taiga Sasaki, Yuki Shukuda, Takao Takiyama, Ayaka Kurigaki, Yumi Takiyama and 5 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Hiroya KitsunaiDivision of Endocrinology, Metabolism, and Rheumatology, Department of Internal Medicine, Asahikawa Medical University, 1-1, 2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, 078-8510, Japan.
Takashi NanbuDivision of Endocrinology, Metabolism, and Rheumatology, Department of Internal Medicine, Asahikawa Medical University, 1-1, 2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, 078-8510, Japan.
Fumika MaruyamaDivision of Endocrinology, Metabolism, and Rheumatology, Department of Internal Medicine, Asahikawa Medical University, 1-1, 2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, 078-8510, Japan.
Tasuku SatoDivision of Endocrinology, Metabolism, and Rheumatology, Department of Internal Medicine, Asahikawa Medical University, 1-1, 2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, 078-8510, Japan.
Yuri TakiyamaDivision of Endocrinology, Metabolism, and Rheumatology, Department of Internal Medicine, Asahikawa Medical University, 1-1, 2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, 078-8510, Japan.
Taiga SasakiDivision of Endocrinology, Metabolism, and Rheumatology, Department of Internal Medicine, Asahikawa Medical University, 1-1, 2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, 078-8510, Japan.
Yuki ShukudaDivision of Endocrinology, Metabolism, and Rheumatology, Department of Internal Medicine, Asahikawa Medical University, 1-1, 2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, 078-8510, Japan.
Takao TakiyamaDivision of Endocrinology, Metabolism, and Rheumatology, Department of Internal Medicine, Asahikawa Medical University, 1-1, 2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, 078-8510, Japan.
Ayaka KurigakiDivision of Endocrinology, Metabolism, and Rheumatology, Department of Internal Medicine, Asahikawa Medical University, 1-1, 2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, 078-8510, Japan.
Yumi TakiyamaDivision of Endocrinology, Metabolism, and Rheumatology, Department of Internal Medicine, Asahikawa Medical University, 1-1, 2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, 078-8510, Japan.
Atsuko AbikoDivision of Diabetology & Endocrinology Department, Japanese Red Cross Asahikawa Hospital, 1-1-1, Akebono 1-Jo, Asahikawa, Hokkaido, 070-0061, Japan.
Yoshihiro MiyamotoDivision of Diabetology, Endocrinology and Metabolism, Department of Internal Medicine, Asahikawa City Hospital, 1-Chome, Kinseicho, Asahikawa, Hokkaido, 070-8610, Japan.
Reiko HommaDivision of Metabolism and Endocrinology, Department of Internal Medicine, Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital, 24-111, 1-Jodori, Asahikawa, Hokkaido, 078-8211, Japan.
Fuminori HiranoDivision of Gastroenterology, Department of Internal Medicine, NHO Asahikawa Medical Center, 7-4048, Hanasaki-Cho, Asahikawa, Hokkaido, 070-8644, Japan.
Hiroshi NomotoDivision of Endocrinology, Metabolism, and Rheumatology, Department of Internal Medicine, Asahikawa Medical University, 1-1, 2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, 078-8510, Japan. hnomoto@asahikawa-med.ac.jp.ORCID http://orcid.org/0000-0003-0713-221X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMultiple 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.

methodsThe 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 registrationThis 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.

Indexed as

Diabetes Mellitus, Type 2Hypoglycemic AgentsInsulinPatient SatisfactionAdultBiomarkersBlood GlucoseDrug Administration ScheduleFemaleGlycated HemoglobinHumansJapanMaleMiddle AgedMulticenter Studies as TopicProspective StudiesBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinClinical trialImegliminInsulinType 2 diabetes

Identifiers

PMID41345697
PMCPMC12781492

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.