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(1c); <8.0%, ≥8.0–<9.0%, ≥9.0%), body mass index (<25, ≥25–<30, ≥30 kg/m(2)) and age (<65, ≥65 years). RESULTS: In DUAL I Japan, reductions in HbA(1c) 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(1c) and age in DUAL I Japan, and for IDegLira versus degludec for baseline HbA(1c) 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(1c) ≥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(1c) in Japanese participants with type 2 diabetes across baseline HbA(1c), body mass index and age categories, without unexpected safety issues.