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Efficacy and Safety of IDegLira Versus Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes Uncontrolled on Metformin and Basal Insulin: The DUAL VII Randomized Clinical Trial

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dc.contributor.author Billings, L.K.
dc.contributor.author Doshi, A.
dc.contributor.author Gouet, D.
dc.contributor.author Oviedo, A.
dc.contributor.author Rodbard, H.W.
dc.contributor.author Tentolouris, N.
dc.contributor.author Grøn, Randi
dc.contributor.author Halladin, Natalie
dc.contributor.author Jódar Gimeno, Esteban
dc.date.accessioned 2018-05-10T16:30:41Z
dc.date.available 2018-05-10T16:30:41Z
dc.date.issued 2018
dc.identifier.citation Billings, L. K., Doshi, A., Gouet, D., Oviedo, A., Rodbard, H. W., Tentolouris, N., ... & Jodar, E. (2018). Efficacy and Safety of IDegLira Versus Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes Uncontrolled on Metformin and Basal Insulin: The DUAL VII Randomized Clinical Trial. Diabetes Care, 41(5), 1009-1016. DOI: 10.2337/dc17-1114 spa
dc.identifier.issn 0149-5992
dc.identifier.issn 1935-5548
dc.identifier.uri http://hdl.handle.net/11268/7251
dc.description.abstract Objetive: In patients with uncontrolled type 2 diabetes on basal insulin, prandial insulin may be initiated. We assessed the efficacy and safety of initiating insulin degludec/liraglutide fixed-ratio combination (IDegLira) versus basal-bolus insulin. Research Design and Methods: A phase 3b trial examined patients with uncontrolled type 2 diabetes on insulin glargine (IGlar U100) 20–50 units/day and metformin, randomized to IDegLira or IGlar U100 and insulin aspart ≤4 times per day. Results: Glycated hemoglobin (HbA1c) decreased from 8.2% (66 mmol/mol) to 6.7% (50 mmol/mol) with IDegLira and from 8.2% (67 mmol/mol) to 6.7% (50 mmol/mol) with basal-bolus (estimated treatment difference [ETD] −0.02% [95% CI −0.16, 0.12]; −0.2 mmol/mol [95% CI −1.7, 1.3]), confirming IDegLira noninferiority versus basal-bolus (P < 0.0001). The number of severe or blood glucose–confirmed symptomatic hypoglycemia events was lower with IDegLira versus basal-bolus (risk ratio 0.39 [95% CI 0.29, 0.51]; rate ratio 0.11 [95% CI 0.08, 0.17]). Body weight decreased with IDegLira and increased with basal-bolus (ETD −3.6 kg [95% CI −4.2, −2.9]). Fasting plasma glucose reductions were similar; lunch, dinner, and bedtime self-monitored plasma glucose measurements were significantly lower with basal-bolus. Sixty-six percent of patients on IDegLira vs. 67.0% on basal-bolus achieved HbA1c <7.0% (53 mmol/mol). Total daily insulin dose was lower with IDegLira (40 units) than basal-bolus (84 units total; 52 units basal). Conclusions: In patients with uncontrolled type 2 diabetes on IGlar U100 and metformin, IDegLira treatment elicited HbA1c reductions comparable to basal-bolus, with statistically superior lower hypoglycemia rates and weight loss versus weight gain. spa
dc.description.sponsorship SIN FINANCIACIÓN spa
dc.language.iso eng spa
dc.title Efficacy and Safety of IDegLira Versus Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes Uncontrolled on Metformin and Basal Insulin: The DUAL VII Randomized Clinical Trial spa
dc.type article spa
dc.description.impact 15,270 JCR (2018) Q1, 4/145 Endocrinology & Metabolism spa
dc.identifier.doi 10.2337/dc17-1114
dc.rights.accessRights openAccess spa
dc.subject.uem Diabetes tipo 2 spa
dc.subject.uem Insulina spa
dc.subject.unesco Sistema endocrino spa
dc.subject.unesco Tratamiento médico spa
dc.description.filiation UEM spa
dc.relation.publisherversion http://dx.doi.org/10.2337/dc17-1114 spa
dc.peerreviewed Si spa


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