Evidence mapPaperPMID 37610062Full record

SynthesisJournal of diabetes investigation2023

Efficacy, safety and tolerability of imeglimin in patients with type 2 diabetes mellitus: A meta-analysis of randomized controlled trials.

Katsuhiko Hagi, Masahiro Nitta, Hirotaka Watada, Kohei Kaku, Kohjiro Ueki

Open access · goldAbstract readMeta-Analysis
In one paragraph

Synthesis in Journal of diabetes investigation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.6field-weighted citation impact, top 9% of its field
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

11 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
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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

5 authors at 4 institutions in 1 country.

Katsuhiko HagiMedical Affairs, Sumitomo Pharma Co., Ltd., Tokyo, Japan.ORCID https://orcid.org/0000-0003-1389-1474
Masahiro NittaMedical Affairs, Sumitomo Pharma Co., Ltd., Tokyo, Japan.
Hirotaka WatadaDepartment of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.ORCID https://orcid.org/0000-0001-5961-1816
Kohei KakuDepartment of Internal Medicine, Kawasaki Medical School, Okayama, Japan.ORCID https://orcid.org/0000-0003-1574-0565
Kohjiro UekiDepartment of Molecular Diabetic Medicine, Diabetes Research Center, National Center for Global Health and Medicine, Tokyo, Japan.
Sumitomo Dainippon Pharma (Japan) · JPJuntendo University · JPKawasaki Medical School · JPNational Center for Global Health and Medicine · JP

Funding

Sumitomo Pharma
6 · The paper itself

Abstract

AIMS/

introductionThis meta-analysis aimed to evaluate the efficacy and safety/tolerability of imeglimin, a novel oral antihyperglycemic agent, administered as monotherapy and adjunctive therapy in patients with type 2 diabetes mellitus. MATERIALS AND

methodsParallel-group randomized controlled trials comparing imeglimin with placebo in adults with type 2 diabetes mellitus were included. Risk ratios or weighted mean differences (WMD) and 95% confidence intervals (CIs) were calculated using random effects models. The primary outcome for efficacy was the change in glycated hemoglobin (HbA1c). Secondary outcomes included other efficacy-related outcomes, specific adverse events, and changes in body weight and lipid parameters.

resultsNine randomized controlled trials (n = 1,655) were included. When analyzed by dose, there was a significant difference in glycated hemoglobin (%) between imeglimin monotherapy and placebo at doses >1,000 mg twice daily (1,000 mg: studies N = 3, patients n = 517, WMD = -0.714, P < 0.001; 1,500 mg: N = 5, n = 448, WMD = -0.531, P = 0.020; 2,000 mg: N = 1, n = 149, WMD = -0.450, P = 0.005). Imeglimin adjunctive therapy significantly improved glycated hemoglobin over placebo at doses of 1,000 mg (N = 1, n = 214, WMD = -0.600, P < 0.001) and 1,500 mg (N = 2, n = 324, WMD = -0.576, P < 0.001). Subgroup analysis of the primary outcome showed that imeglimin was effective regardless of chronic kidney disease category, with studies carried out in Japan and in patients with lower body mass index showing a trend toward improved imeglimin efficacy. There were no significant differences between imeglimin and placebo in the risk of all-cause discontinuation and the proportion of patients who presented with at least one adverse event.

conclusionsImeglimin is efficacious, safe, and well tolerated as monotherapy and adjunctive therapy.

Indexed as

Diabetes Mellitus, Type 2AdultGlycated HemoglobinHumansHypoglycemic AgentsRandomized Controlled Trials as TopicTriazinesGlycated HemoglobinHypoglycemic AgentsimegliminTriazinesImegliminMeta-analysisType 2 diabetes mellitus

Identifiers

PMID37610062
PMCPMC10583642
OpenAlexW4386083921

What Socratic holds

Textmetadata
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.