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dc.contributor.author | Pozzilli, Paolo | |
dc.contributor.author | Norwood, Paul | |
dc.contributor.author | Jódar Gimeno, José Esteban | |
dc.contributor.author | Davies, Melanie J. | |
dc.contributor.author | Ivanyi, Tibor | |
dc.contributor.author | Jiang, Honghua | |
dc.contributor.author | Woodward, Bradley | |
dc.contributor.author | Milicevic, Zvonko | |
dc.date.accessioned | 2018-04-06T08:32:42Z | |
dc.date.available | 2018-04-06T08:32:42Z | |
dc.date.issued | 2017 | |
dc.identifier.citation | Pozzilli, P., Norwood, P., Jódar, E., Davies, M. J., Ivanyi, T., Jiang, H., ... & Milicevic, Z. (2017). Placebo‐controlled, randomized trial of the addition of once‐weekly glucagon‐like peptide‐1 receptor agonist dulaglutide to titrated daily insulin glargine in patients with type 2 diabetes (AWARD‐9). Diabetes, Obesity and Metabolism, 19(7), 1024-1031. DOI: 10.1111/dom.12937 | spa |
dc.identifier.issn | 1462-8902 | |
dc.identifier.issn | 1463-1326 | |
dc.identifier.uri | http://hdl.handle.net/11268/7191 | |
dc.description.abstract | Aim: To compare the addition of weekly dulaglutide vs the addition of placebo to titrated glargine in patients with type 2 diabetes (T2D) with sub‐optimum glycated haemoglobin (HbA1c) concentration. Materials and Methods: Patients (N = 300) from this phase III, double‐blind, parallel‐arm, placebo‐controlled study were randomized to weekly subcutaneous injections of dulaglutide 1.5 mg or placebo with titrated daily glargine (mean ± standard deviation baseline dose: 39 ± 22 U), with or without metformin (≥1500 mg/d). The primary endpoint was superiority of dulaglutide/glargine to placebo/glargine with regard to change from baseline in HbA1c level at 28 weeks. Results: Least squares (LS) mean ± standard error (s.e.) HbA1c changes from baseline were −1.44 ± 0.09% (−15.74 ± 0.98 mmol/mol) with dulaglutide/glargine and −0.67 ± 0.09% (−7.32 ± 0.98 mmol/mol) with placebo/glargine at 28 weeks (LS mean difference [95% confidence interval] −0.77% [−0.97, −0.56]; P < .001). Body weight decreased with dulaglutide/glargine and increased with placebo/glargine (LS mean difference: −2.41 ± 0.39 kg; P < .001). Increases from baseline in mean glargine dose were significantly smaller with dulaglutide/glargine vs placebo/glargine (13 ± 2 U [0.1 ± 0.02 U/kg] vs 26 ± 2 U [0.3 ± 0.02 U/kg], respectively; P < .001; LS mean ± s.e. final dose: dulaglutide/glargine, 51 ± 2 U; placebo/glargine, 65 ± 2 U). The hypoglycaemia rate (≤3.9 mmol/L threshold) was 7.69 ± 15.15 and 8.56 ± 16.13 events/patient/year, respectively (P = .488). One episode of severe hypoglycaemia occurred in the dulaglutide/glargine group. Common gastrointestinal adverse events with dulaglutide were nausea (12.0%), diarrhoea (11.3%) and vomiting (6.0%). Conclusions: Weekly dulaglutide 1.5 mg added to basal insulin is an efficacious and well tolerated treatment option for patients with T2D. | spa |
dc.description.sponsorship | Sin financiación | spa |
dc.language.iso | eng | spa |
dc.title | Placebo‐controlled, randomized trial of the addition of once‐weekly glucagon‐like peptide‐1 receptor agonist dulaglutide to titrated daily insulin glargine in patients with type 2 diabetes (AWARD‐9) | spa |
dc.type | article | spa |
dc.description.impact | 5.980 JCR (2017) Q1, 18/143 Endocrinology and Metabolism | spa |
dc.identifier.doi | 10.1111/dom.12937 | |
dc.rights.accessRights | openAccess | spa |
dc.subject.uem | Diabetes tipo 2 | spa |
dc.subject.uem | Insulina | spa |
dc.subject.unesco | Tratamiento médico | spa |
dc.subject.unesco | Sistema endocrino | spa |
dc.description.filiation | UEM | spa |
dc.relation.publisherversion | http://dx.doi.org/10.1111/dom.12937 | spa |
dc.peerreviewed | Si | spa |
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