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
Abstract 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...
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doaj-bab18caaa4b04570a18d17e2816f57962021-09-01T18:33:46ZengWileyJournal of Diabetes Investigation2040-11162040-11242021-09-011291610161810.1111/jdi.13525Efficacy 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 trialsMitsuhisa Komatsu0Hirotaka Watada1Shizuka Kaneko2Bue F Ross Agner3Tomoyuki Nishida4Kohei Kaku5Division of Diabetes, Endocrinology and Metabolism Department of Internal Medicine Shinshu University School of Medicine Nagano JapanDepartment of Metabolism and Endocrinology Juntendo University Tokyo JapanTakatsuki Red Cross Hospital Osaka JapanNovo Nordisk A/S Søborg DenmarkNovo Nordisk Pharma Ltd. Tokyo JapanDepartment of Internal Medicine Kawasaki Medical School Kurashiki JapanAbstract 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 ( HbA1c; <8.0%, ≥8.0–<9.0%, ≥9.0%), body mass index (<25, ≥25–<30, ≥30 kg/m2) and age (<65, ≥65 years). Results In DUAL I Japan, reductions in HbA1c 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 HbA1c and age in DUAL I Japan, and for IDegLira versus degludec for baseline HbA1c 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 HbA1c ≥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 HbA1c in Japanese participants with type 2 diabetes across baseline HbA1c, body mass index and age categories, without unexpected safety issues.https://doi.org/10.1111/jdi.13525Insulin degludec/liraglutideJapanType 2 diabetes mellitus |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Mitsuhisa Komatsu Hirotaka Watada Shizuka Kaneko Bue F Ross Agner Tomoyuki Nishida Kohei Kaku |
spellingShingle |
Mitsuhisa Komatsu Hirotaka Watada Shizuka Kaneko Bue F Ross Agner Tomoyuki Nishida Kohei Kaku 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 Journal of Diabetes Investigation Insulin degludec/liraglutide Japan Type 2 diabetes mellitus |
author_facet |
Mitsuhisa Komatsu Hirotaka Watada Shizuka Kaneko Bue F Ross Agner Tomoyuki Nishida Kohei Kaku |
author_sort |
Mitsuhisa Komatsu |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
Wiley |
series |
Journal of Diabetes Investigation |
issn |
2040-1116 2040-1124 |
publishDate |
2021-09-01 |
description |
Abstract 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 ( HbA1c; <8.0%, ≥8.0–<9.0%, ≥9.0%), body mass index (<25, ≥25–<30, ≥30 kg/m2) and age (<65, ≥65 years). Results In DUAL I Japan, reductions in HbA1c 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 HbA1c and age in DUAL I Japan, and for IDegLira versus degludec for baseline HbA1c 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 HbA1c ≥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 HbA1c in Japanese participants with type 2 diabetes across baseline HbA1c, body mass index and age categories, without unexpected safety issues. |
topic |
Insulin degludec/liraglutide Japan Type 2 diabetes mellitus |
url |
https://doi.org/10.1111/jdi.13525 |
work_keys_str_mv |
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