Evidence mapPaperPMID 41615833Full record

Trial reportJournal of diabetes investigation2026

Effects of short-term tofogliflozin treatment on the insulin secretory capacity of people with type 2 diabetes: A randomized controlled trial, the TOP-ELM study.

Maiko Miyamoto, Aika Miya, Akinobu Nakamura, Yuka Takahashi, Yuki Yamauchi, Shingo Yanagiya, Takahiro Takase, Mayuko Ono, Kiyohiko Takahashi, Kazufumi Okada and 4 more

Erratum issuedAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of diabetes investigation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Maiko MiyamotoDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Aika MiyaDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Akinobu NakamuraDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.ORCID https://orcid.org/0000-0002-8192-0006
Yuka TakahashiTonan Hospital, Sapporo, Japan.
Yuki YamauchiTonan Hospital, Sapporo, Japan.ORCID https://orcid.org/0000-0002-8236-5825
Shingo YanagiyaObihiro Kosei Hospital, Obihiro, Japan.
Takahiro TakaseNTT Medical Center Sapporo, Sapporo, Japan.
Mayuko OnoHakodate Central General Hospital, Hakodate, Japan.
Kiyohiko TakahashiHakodate Central General Hospital, Hakodate, Japan.
Kazufumi OkadaInstitute of Health Science Innovation for Medical Care, Hokkaido University Hospital, Sapporo, Hokkaido, Japan.
Hiraku KamedaDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.ORCID https://orcid.org/0000-0003-1870-6688
Kyu Yong ChoDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Tatsuya AtsumiDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
TOP‐ELM study group

Funding

Kowa Pharmaceutical
6 · The paper itself

Abstract

AIMS/

introductionWe aimed to explore the short-term effects of tofogliflozin on the insulin secretory capacity of people with type 2 diabetes. MATERIALS AND

methodsWe performed a multicenter, prospective, randomized, active-controlled, open-label, parallel-group comparison study of people with type 2 diabetes aged 20-89 years, with hemoglobin A1c (HbA1c) 6.5%-9.0%, not previously treated with antihyperglycemic agents. The participants were randomly assigned to a group that received 20 mg tofogliflozin per day or a group that received 500 mg metformin per day for 4 weeks. Fasting blood samples were obtained and oral glucose tolerance testing was performed before and after treatment. The changes from baseline to week 4 in glucose tolerance and insulin secretory capacity were compared.

resultsThirty participants in the metformin group and 35 in the tofogliflozin group completed the study. After 4 weeks, the HbA1c, glycated albumin, and fasting plasma glucose concentrations had significantly decreased in both groups, with no significant differences between the two groups. The fatty liver index improved significantly more in the tofogliflozin group. The disposition index (DI) did not significantly increase in either group, and there was no difference between the groups. However, in the tofogliflozin group, the DI improved in participants with poorer glucose tolerance at baseline or larger improvements after treatment, but not in the metformin group.

conclusionShort-term tofogliflozin therapy did not improve the insulin secretory capacity of treatment-naïve people with type 2 diabetes. However, tofogliflozin may facilitate the early recovery of insulin secretory capacity in individuals with poor glucose tolerance.

Indexed as

Benzhydryl CompoundsDiabetes Mellitus, Type 2GlucosidesHypoglycemic AgentsInsulinInsulin SecretionSodium-Glucose Transporter 2 InhibitorsAdultAgedAged, 80 and overBiomarkersBlood GlucoseFemaleFollow-Up StudiesGlucose Tolerance TestGlycated Hemoglobin6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triolBenzhydryl CompoundsBiomarkersBlood GlucoseGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinMetforminSodium-Glucose Transporter 2 InhibitorsHepatic steatosisInsulin secretory capacityTofogliflozin

Identifiers

PMID41615833
PMCPMC13042503

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
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.