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Efficacy and safety of once-monthly efpeglenatide in patients with type 2 diabetes: Results of a phase 2 placebo-controlled, 16-week randomized dose-finding study
dc.contributor.author | Del Prato, S | |
dc.contributor.author | Kang, JH | |
dc.contributor.author | Trautmann, ME | |
dc.contributor.author | Stewart, J | |
dc.contributor.author | Sorli, CH | |
dc.contributor.author | Derwahl, M | |
dc.contributor.author | Soto Gonzalez, Alfonso | |
dc.contributor.author | Yoon, KH | |
dc.date.accessioned | 2022-04-12T11:37:03Z | |
dc.date.available | 2022-04-12T11:37:03Z | |
dc.date.issued | 2020 | |
dc.identifier.issn | 1462-8902 | |
dc.identifier.other | https://www.ncbi.nlm.nih.gov/pubmed/32128957 | es |
dc.identifier.uri | http://hdl.handle.net/20.500.11940/16448 | |
dc.description.abstract | AIMS: 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.rights | Atribución-NoComercial 4.0 Internacional | |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/4.0/ | |
dc.subject.mesh | Drug Therapy | * |
dc.subject.mesh | Humans | * |
dc.subject.mesh | Treatment Outcome | * |
dc.subject.mesh | Hypoglycemic Agents | * |
dc.subject.mesh | Glucagon-Like Peptides | * |
dc.subject.mesh | Proline | * |
dc.subject.mesh | Double-Blind Method | * |
dc.title | Efficacy and safety of once-monthly efpeglenatide in patients with type 2 diabetes: Results of a phase 2 placebo-controlled, 16-week randomized dose-finding study | en |
dc.type | Journal Article | es |
dc.authorsophos | Del Prato, S Kang, JH Trautmann, ME Stewart, J Sorli, CH Derwahl, M Soto, A Yoon, KH | |
dc.identifier.doi | 10.1111/dom.14020 | |
dc.identifier.pmid | 32128957 | |
dc.identifier.sophos | 38733 | |
dc.issue.number | 7 | es |
dc.journal.title | DIABETES OBESITY & METABOLISM | es |
dc.organization | Servizo Galego de Saúde::Estrutura de Xestión Integrada (EOXI)::EOXI de A Coruña - Complexo Hospitalario Universitario de A Coruña::Endocrinoloxía | es |
dc.page.initial | 1176 | es |
dc.page.final | 1186 | es |
dc.rights.accessRights | openAccess | |
dc.subject.decs | resultado del tratamiento | * |
dc.subject.decs | péptidos glucagonoides | * |
dc.subject.decs | farmacoterapia | * |
dc.subject.decs | humanos | * |
dc.subject.decs | prolina | * |
dc.subject.decs | método con doble ocultación | * |
dc.subject.decs | hipoglicemiantes | * |
dc.subject.keyword | CHUAC | es |
dc.typefides | Artículo Original | es |
dc.typesophos | Artículo Original | es |
dc.volume.number | 22 | es |