Efficacy and Safety of the Fixed-ratio Combination of Insulin Degludec and Liraglutide by Baseline Glycated Hemoglobin, Body Mass Index and Age in Japanese Individuals with Type 2 Diabetes: A Subgroup Analysis of Two Phase III Trials

Aims/introduction: To assess efficacy and safety of insulin degludec/liraglutide (IDegLira) in Japanese participants with type 2 diabetes across different baseline characteristics.

Materials And Methods: Data from two randomized controlled trials were used: DUAL I Japan (n = 819 insulin-naïve participants) and DUAL II Japan (n = 210 insulin-experienced participants). Outcomes were assessed according to baseline glycated hemoglobin ( HbA ; <8.0%, ≥8.0-<9.0%, ≥9.0%), body mass index (<25, ≥25-<30, ≥30 kg/m ) and age (<65, ≥65 years).

Results: In DUAL I Japan, reductions in HbA with IDegLira versus degludec and liraglutide were observed across all subgroups (treatment differences: -0.48% to -0.72% vs degludec, -0.29% to -0.73% vs liraglutide). Results were similar with IDegLira versus degludec in DUAL II Japan (treatment differences: -0.82% to -1.61%). Treatment-by-subgroup interactions were significant for IDegLira versus liraglutide for baseline HbA and age in DUAL I Japan, and for IDegLira versus degludec for baseline HbA in DUAL II Japan. In DUAL I Japan, IDegLira was associated with less weight gain than degludec in most subgroups. In DUAL II Japan, IDegLira was associated with a small mean weight loss (except for baseline HbA ≥9.0%) versus a small gain for degludec (except for age ≥65 years subgroup); treatment-by-subgroup interactions were not significant. Total daily insulin dose was lower with IDegLira versus degludec across all categories, except for age >65 years in DUAL II Japan.

Conclusions: IDegLira reduced HbA in Japanese participants with type 2 diabetes across baseline HbA , body mass index and age categories, without unexpected safety issues.