IDegLira is efficacious across baseline HbA1c categories in subjects with Type 2 diabetes uncontrolled on sulphonylurea, glucagon-like peptide-1 receptor agonist or insulin glargine U100: analyses from completed phase 3b trials

Viljoen, AdieSorli, Ch.Harris, StewartJódar Gimeno, José EstebanLingvay, IldikoChandarana, KevalLanger, J.Jaeckel, Elmar2018-04-162018-04-162017Viljoen, A., Sorli, Ch., Harris, S., Jódar, E. Lingvay, I., Chandarana, K., Langer, J., & Jaeckel, E. (2017). IDegLira is efficacious across baseline HbA1c categories in subjects with Type 2 diabetes uncontrolled on sulphonylurea, glucagon-like peptide-1 receptor agonist or insulin glargine U100: analyses from completed phase 3b trials. In Diabetes UK Professional Conference. Diabetic Medicine, 34(Suppl. s1), 160. http://dx.doi.org/10.1111/dme.37_13304http://hdl.handle.net/11268/7223Aims: Previous analyses of phase 3a trials (DUAL I extension;DUAL II) showed IDegLira (insulin degludec/liraglutide combina-tion) is efﬁcacious irrespective of baseline HbA1c. This analysisaimed to conﬁrm this observation in additional populations withType 2 diabetes uncontrolled on (i) a glucagon-like peptide-1receptor agonist (GLP-1RA) (DUAL III: IDegLira vs unchangedGLP-1RA), (ii) sulphonylurea metformin (DUAL IV: IDegLiravs placebo) or (iii) insulin glargine (IGlar U100) (DUAL V:IDegLira vs continued IGlar U100 titration). Methods: DUAL III–V were 26 week, randomised trials. IDe-gLira starting dose was 10 dose steps (1 dose step = 1 unit IDeg +0.036mg Lira) in DUAL IV and 16 dose steps in DUAL III and V;maximum IDegLira dose: 50 dose steps. This post hoc analysisgrouped subjects by baseline HbA1c; ≤7.5, > 7.5–≤8.5and > 8.5%.Results: In all trials a higher baseline HbA1c resulted in greaterHbA1c reductions. The change in HbA1c was signiﬁcantly greater(p < 0.01) with IDegLira vs comparator in all baseline HbA1cgroups with a similar estimated treatment difference (baselineHbA1c ≤7.5, > 7.5–≤8.5 and > 8.5%: -0.74, -1.13, -1.18; -0.91, -1.00, -1.36; -0.48, -0.55, -0.68 for DUAL III, IV and V,respectively). In all trials for all baseline HbA1c groups, IDegLiradecreased mean HbA1c to < 7% at end of trial. In DUAL V, theonly trial to include patients with HbA1c > 9% (median 9.5%),HbA1c was reduced to 6.9% with IDegLira vs 7.8% with IGlarU100. Conclusions: Signiﬁcant HbA1c reductions occur with IDegLiraregardless of baseline HbA1c group or study population.engIDegLira is efficacious across baseline HbA1c categories in subjects with Type 2 diabetes uncontrolled on sulphonylurea, glucagon-like peptide-1 receptor agonist or insulin glargine U100: analyses from completed phase 3b trialsconference output10.1111/dme.37_13304open accessSistema endocrinoEnfermedad