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

Abstract

Aims: 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.