{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["7(6)"],"submitter":["Derumeaux G"],"pubmed_abstract":["<h4>Objectives</h4>REGULATE trial was designed to compare the efficacy and safety of benfluorex versus pioglitazone in type 2 diabetes mellitus (DM) patients.<h4>Methods</h4>Double-blind, parallel-group, international, randomised, non-inferiority trial. More than half of the 196 participating centres were primary care centres. Patients eligible had type 2 DM uncontrolled on sulfonylurea. 846 were randomised. They received study treatment for 1 year. 423 patients were allocated to benfluorex (150 to 450 mg/day) and 423 were allocated to pioglitazone (30 to 45 mg/day). Primary efficacy criterion was HbA(1c). Safety assessment included blinded echocardiographic evaluation of cardiac and valvular status.<h4>Results</h4>At baseline, patients were 59.1 ± 10.5 years old with HbA1c 8.3 ± 0.8%, and"],"journal":["PloS one"],"pagination":["e38273"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC3378581"],"repository":["biostudies-literature"],"pubmed_title":["Echocardiographic evidence for valvular toxicity of benfluorex: a double-blind randomised trial in patients with type 2 diabetes mellitus."],"pmcid":["PMC3378581"],"pubmed_authors":["Senn S","Mannessier B","Boiche P","Galvez J","Speier U","Mikolaiczik M","Herve B","Romanova H","Faligot S","Tirouflet D","Spiess HW","Guinot V","Burgess L","Nabedian E","Desprez P","Latte T","Lognos-Folco B","Cochet D","Lousqui C","Harroch M","Granier M","Fawaz A","Vogel J","Blouza S","Bekherraz A","Bastide V","Tordjman J","Fhal G","Delsart D","Brunel PJ","Camper E","Sarais O","Godde P","Wachter J","Andre P","Benayoune S","Bolo A","Bloud 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More than half of the 196 participating centres were primary care centres. Patients eligible had type 2 DM uncontrolled on sulfonylurea. 846 were randomised. They received study treatment for 1 year. 423 patients were allocated to benfluorex (150 to 450 mg/day) and 423 were allocated to pioglitazone (30 to 45 mg/day). Primary efficacy criterion was HbA(1c). Safety assessment included blinded echocardiographic evaluation of cardiac and valvular status.<h4>Results</h4>At baseline, patients were 59.1 ± 10.5 years old with HbA1c 8.3 ± 0.8%, and","dates":{"release":"2012-01-01T00:00:00Z","publication":"2012","modification":"2025-04-04T21:17:29.903Z","creation":"2019-03-26T23:10:31Z"},"accession":"S-EPMC3378581","cross_references":{"pubmed":["22723853"],"doi":["10.1371/journal.pone.0038273"]}}