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dc.contributor.authorDel Prato, S
dc.contributor.authorKang, JH
dc.contributor.authorTrautmann, ME
dc.contributor.authorStewart, J
dc.contributor.authorSorli, CH
dc.contributor.authorDerwahl, M
dc.contributor.authorSoto Gonzalez, Alfonso 
dc.contributor.authorYoon, KH
dc.date.accessioned2022-04-12T11:37:03Z
dc.date.available2022-04-12T11:37:03Z
dc.date.issued2020
dc.identifier.issn1462-8902
dc.identifier.otherhttps://www.ncbi.nlm.nih.gov/pubmed/32128957es
dc.identifier.urihttp://hdl.handle.net/20.500.11940/16448
dc.description.abstractAIMS: To determine the optimal dose(s) of once-monthly administration of efpeglenatide, a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), in patients with type 2 diabetes (T2D) inadequately controlled on metformin. MATERIALS AND METHODS: In this phase 2, randomized, placebo-controlled, double-blind trial (NCT02081118), patients were randomized 1:1:1:1 to subcutaneous efpeglenatide (8, 12 or 16 mg once monthly; n = 158) or placebo (n = 51). The 16-week treatment period included a 4-week titration phase with once-weekly efpeglenatide 4 mg, followed by one dose of efpeglenatide 8 mg once monthly and two doses of the assigned once-monthly dose. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to week 17. RESULTS: All efpeglenatide doses significantly reduced HbA1c versus placebo (P < 0.0001 for all). Overall, the least squares mean difference in HbA1c reductions between efpeglenatide and placebo was -7.7 mmol/mol (-0.71%; baseline to week 17). At week 17, a significantly greater proportion of efpeglenatide patients had an HbA1c level <53 mmol/mol (<7%) versus placebo (48.7% vs. 30.6%; P = 0.0320). Significant body weight loss occurred across all efpeglenatide doses (placebo-corrected reduction -2.0 kg [efpeglenatide overall]; P = 0.0003). The safety profile was consistent with GLP-1RAs, with gastrointestinal (GI) disorders being the most common treatment-emergent adverse events. Fluctuations in effects on glucose levels and rates of GI events occurred between peak and trough efpeglenatide concentrations. CONCLUSIONS: Efpeglenatide once monthly (following once-weekly titration) has significant benefits with regard to HbA1c and weight reduction versus placebo in patients with T2D. Further studies are needed to evaluate the long-term efficacy and safety of efpeglenatide once monthly.en
dc.rightsAtribución-NoComercial 4.0 Internacional
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/
dc.subject.meshDrug Therapy*
dc.subject.meshHumans*
dc.subject.meshTreatment Outcome*
dc.subject.meshHypoglycemic Agents*
dc.subject.meshGlucagon-Like Peptides*
dc.subject.meshProline*
dc.subject.meshDouble-Blind Method*
dc.titleEfficacy and safety of once-monthly efpeglenatide in patients with type 2 diabetes: Results of a phase 2 placebo-controlled, 16-week randomized dose-finding studyen
dc.typeJournal Articlees
dc.authorsophosDel Prato, S Kang, JH Trautmann, ME Stewart, J Sorli, CH Derwahl, M Soto, A Yoon, KH
dc.identifier.doi10.1111/dom.14020
dc.identifier.pmid32128957
dc.identifier.sophos38733
dc.issue.number7es
dc.journal.titleDIABETES OBESITY & METABOLISMes
dc.organizationServizo Galego de Saúde::Estrutura de Xestión Integrada (EOXI)::EOXI de A Coruña - Complexo Hospitalario Universitario de A Coruña::Endocrinoloxíaes
dc.page.initial1176es
dc.page.final1186es
dc.rights.accessRightsopenAccess
dc.subject.decsresultado del tratamiento*
dc.subject.decspéptidos glucagonoides*
dc.subject.decsfarmacoterapia*
dc.subject.decshumanos*
dc.subject.decsprolina*
dc.subject.decsmétodo con doble ocultación*
dc.subject.decshipoglicemiantes*
dc.subject.keywordCHUACes
dc.typefidesArtículo Originales
dc.typesophosArtículo Originales
dc.volume.number22es


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