Show simple item record

dc.rights.licenseopenen_US
dc.contributor.authorDUBOURG, J.
dc.contributor.authorUEKI, K.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorGROUIN, Jean-Marie
dc.contributor.authorFOUQUERAY, P.
dc.date.accessioned2021-03-15T13:33:35Z
dc.date.available2021-03-15T13:33:35Z
dc.date.issued2020-12-04
dc.identifier.issn1463-1326 (Electronic) 1462-8902 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/26660
dc.description.abstractEnAIMS: The aim of this study was to assess the efficacy and safety of imeglimin monotherapy compared to placebo for 24 weeks in Japanese patients with type 2 diabetes mellitus (T2DM). MATERIAL AND METHODS: In this 24-week, randomized, double-blind, placebo-controlled, parallel group, dose ranging, phase 2b clinical trial, Japanese adults (age ? 20 years) with T2DM either treatment-na�ve or previously treated with one oral anti-diabetes agent were eligible for participation. Patients were randomly assigned (1:1:1:1) to receive orally imeglimin 500 mg or imeglimin 1000 mg or imeglimin 1500 mg, or placebo twice daily over a 24-week period. The primary endpoint was the placebo-adjusted change at week 24 in HbA1c. Safety outcomes were assessed in all patients that received at least one dose of study drug. This trial is registered at JAPIC (JapicCTI-153086). RESULTS: A total of 299 patients were randomized to receive double-blind treatment with orally twice-daily placebo (n= 75), imeglimin 500 mg (n=75), 1000 mg (n=74) or 1500 mg (n=75). At week 24, imeglimin significantly decreased HbA1c (difference vs placebo: imeglimin 500 mg -0.52% (95% CI: -0.77, -0.27), imeglimin 1000 mg -0.94% (95% CI: -1.19, -0.68), imeglimin 1500 mg -1.00% (95% CI: -1.26, -0.75) (p < 0.0001 for all). Treatment-emergent adverse events (TEAE) were reported for 68.0%, 62.2%, 73.3% and 68.0% of patients receiving imeglimin 500 mg, imeglimin 1000 mg, imeglimin 1500 mg and placebo, respectively. A small increase in gastrointestinal adverse effects (e.g. diarrhea) occurred with the 1500 mg dose level. Hypoglycemia was balanced between groups. CONCLUSIONS: Imeglimin as monotherapy in Japanese patients with T2DM was well tolerated and significantly improved glycemic control with no significant increase in hypoglycemic events versus placebo. Given the marginal increase in efficacy with the 1500 mg vs. 1000 mg dose (along with the potential for gastrointestinal tolerability issues), a dose of 1000 mg BID was selected for subsequent Phase III studies.
dc.language.isoENen_US
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/us/*
dc.title.enEfficacy and safety of imeglimin in Japanese patients with type 2 diabetes: A 24-week, randomized, double-blind, placebo-controlled, dose-ranging phase 2b trial
dc.title.alternativeDiabetes Obes Metaben_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1111/dom.14285en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed33275318en_US
bordeaux.journalDiabetes, Obesity and Metabolismen_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.teamPharmacoEpi-Drugsen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03169589
hal.version1
hal.date.transferred2021-03-15T13:33:40Z
hal.exporttrue
bordeaux.COinSctx_ver=Z39.88-2004&amp;rft_val_fmt=info:ofi/fmt:kev:mtx:journal&amp;rft.jtitle=Diabetes,%20Obesity%20and%20Metabolism&amp;rft.date=2020-12-04&amp;rft.eissn=1463-1326%20(Electronic)%201462-8902%20(Linking)&amp;rft.issn=1463-1326%20(Electronic)%201462-8902%20(Linking)&amp;rft.au=DUBOURG,%20J.&amp;UEKI,%20K.&amp;GROUIN,%20Jean-Marie&amp;FOUQUERAY,%20P.&amp;rft.genre=article


Files in this item

Thumbnail
Thumbnail

This item appears in the following Collection(s)

Show simple item record