biostudies-literatureUnknown7(6)Derumeaux G<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%, andPloS onee38273https://www.ebi.ac.uk/biostudies/studies/S-EPMC3378581biostudies-literatureEchocardiographic evidence for valvular toxicity of benfluorex: a double-blind randomised trial in patients with type 2 diabetes mellitus.PMC3378581Senn SMannessier BBoiche PGalvez JSpeier UMikolaiczik MHerve BRomanova HFaligot STirouflet DSpiess HWGuinot VBurgess LNabedian EDesprez PLatte TLognos-Folco BCochet DLousqui CHarroch MGranier MFawaz AVogel JBlouza SBekherraz ABastide VTordjman JFhal GDelsart DBrunel PJCamper ESarais OGodde PWachter JAndre PBenayoune SBolo ABloud RMesnier PLServan EMerad LHenri PBoulenge JLiotard FHocquelet JFWagner-Ballon JMercier CHKrizova JKlausmann GRouault PNocolas JMeme BKosch CTouret BDieumegard JYBourgeois-Adragna ODuroux GVogel MWeisweiler PBlondin MLPotiez SPierron RAudouy PChagnoux BBaert MWellmann HDesvallees PGroell RMantz SAdam FMSauli PCharbonnel LSiegrist SVincent BHamou AMuller OMuller PTetaud DMagnani CEtienne JCBonnefoy MPoupard JPBoute DGrimard EPinsembert DHuberschwiller JLSmila DAsgaraly KCaduc RChignon JPAudibert MDupont SKacem MSosa AScelles VDugny GGarot AHodebourg de Verbois FWeiss BPopescu ABouzo HThiebaut FJacques JLGacioch MWaitman JBoutonnat YDaguzan BLakhaSan Galli FDistiller LPaillard GMJude NZidi BLeveque YAlawi HRipoll MLaburte PBorys JMParamesh SCanali TRais NCourtois SKronek DTeisseire JPStumpf GPiquet PBedouet RGuaymas GJMorel HMercier PBuschmann UCihalik CBoye ALafon PSampoux HHalimi SLacroix PVJean MCini SKutejova VScholz GLe Fevre GFrohn MLemaire ALevha PPicandet BLibman AGevrey CThevenard EAmmini ACde Collart GVila MLambilliotte JDelarue JMCottencin JFVarthakavi POulmekki MAssuncao ALejeune Wright MPurr JIngrand JCGuilloux JPHenry JPChandratreya SAEdet DTrottier GMarie DBlignaut SLe Ponner CJousset OMoussu PDillinger JHasalova Zapletalova JConstantin GThibault RFrancillotti ASarkis RDubourg DBaland-Peltre KPennetier PMarcucci GFlosi MDubourg HCharrier BBioche PProchasson ABrugnaux JPCharbonnier YDedieu-Anglade NRichir BBully CGleize JLBindler GAbdel Qader MVanpraet JJMigliorini PKaplan HLejay DPommet-Nicot CVan Gaal LCeusters TSamat Jde Sainte Lorette EDelavigne FEtchegaray Gde LapertosaGrassart ESchaupp TBouriaud MCastelnau PHey KHMongin GBertrand GMolinier JFBeignot Devalmont PMichel FBiquet DLe Gall PRivoallan YMKarsenti BPujade HHHumbert TVan Gall LGuedon JLCastelli BPellenq BJacquin PPellenq DTournemine NAuriault JRBenady RSlama BBenady MOlsovsky JWelsing LChowdhury SPitoun MJoly FDepret Bixio GHennecke RAbrial-Besson FEmanuely PAerts PNocent PBeaudoin JNaud EPradeau RRequin-Thimothee PRavaut JFErnande LAlimi NTurot JCSavary PFoucat JGendrin VGiner MZimmermann DLichiardopol RBruckert ERiedl MFrick HMAllegret JFRebot JBermond YDesrues HAroun JMSerusclat PGiacomino ALopez JPPaulet CPourcin JDjait FSebbah ALe Guerroue ADerumeaux GSerusclat ACouffin YBismuth MRiviere MCourvoisier JCLanos OLoiselet PMabire PMazghani SYaeche PPeraldi JBouillot PGarrigue LToledano JMauriere SCurlier CEstadieu COlivier YBernard MHGruchala PGarrigue SFaugas GPrat JStoll APineau-Valencienne DKorsec PCerna CSarradon ADubois JFLoquillard HDecugis MBenameur DDefontaine ALetzelter JMJaballah ICohen MPipet LCohen SPaveliu FMarmor PCohen AKvapil MJacquety EFleury MBrionnet-Metzger SGrazzini JPLemoine CMarzin YPanus CChaieb LSoulard JPPop LUrlea-Schon INortje HTuszynski DMaffei LGrandmottet-Egermann MYajnik CRost JPRokbani LAupy JMPenning Reef JPeluau JGontharet BPinot MColom FXDesignolle PRousseau GDe Botton PGraur MGener CTreguer PYDuplan ASteff FNicolau-Langlade SLievaux TNuel JHuet CRenault EAchour ACambau OMusso SRousseau-Durand RFineltain JDelamare GScaccia PPabst JMJamilloux DLemarie BOsho YKumar KMTerracol PBernhard JRichter DBoyer PBonneau DCrappier JJBenmati YBlouin PAussedat CNavarranne AReissig FMoore RPetit ACermak OPaffoy JCBecq JPMarty JTricoire GBlot EBueche DLion AHerent MZalewski CGanapathi BHerrero LGuinement EBen Slama CPasquini VLimal AMSacareau DPenet Dvan Rensburg JObellianne GRegnaut FPrijac BRichard JSinay IPiffeteau-Gaston IBraunsteffer TVrinat JMFarina MDarsy PLarche DDugue PPoivet-Ripoche LTomas FDurel GLeyendecker PDemolliens BChevallier-Salkind BOger TEngelbrecht IGeromini OVidal DJourde PMoulin PGrandmottet GCampagne ASavidan JYMouchet JCFounini ADrouin MEveno MPSandres-Banon DAicardo PBisch ODages LFaingold MCGuinet JMSanchez JMMahot DChuret JBNavarre VDasse AEoche RVillard BLe Ponner-Leport CBeauchef HBineau BRoge GMestre LSimmons AEhrlich JMMartocq GPaveau ASastre RBlanc MAbenhaim NRichard AAmate MJung TKapinos RBoda-Buccino MSenk DMussat PFrery-Coste MMarin DBoucher LMailly DMorez YBourneuf PNunez SDuval MLalanne GParent DLequeux YBenhaim RPradere HAubert DDelbecq DRey FBehar MDuret Rolland MRobert PCazes CREGULATE trial investigatorsBrechoire DRousset HDuroy CGuyon JGaube JCBeugin YPeyre ERochez-Fraiberg MRobert GTilly Cde LemosPhelippeau YMithal ADahan LPBegey SBuffard BGavini FAlaoui ASoloy JCSalambo ESicard AChuberre YLeonti FBoyes JPLecaignard DAim LJambut PLe Gall JLSicard JCorre BSauvage PDelannay BHonthaas CKombacher HDSpilthooren FEuvrard JMDelachienne ASeite PRoumaneix DSlimane HBrunet EZoro PMasson ABrezina JRidel CGiroux TDelbecque DFoubert ORouchaud EBenech AVawda FMassari FKumar KJoseph CGonzales JMutha AWendisch UfalseEchocardiographic evidence for valvular toxicity of benfluorex: a double-blind randomised trial in patients with type 2 diabetes mellitus.<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%, and2012-01-01T00:00:00Z20122025-04-04T21:17:29.903Z2019-03-26T23:10:31ZS-EPMC33785812272385310.1371/journal.pone.0038273