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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Main Authors: Mitsuhisa Komatsu, Hirotaka Watada, Shizuka Kaneko, Bue F Ross Agner, Tomoyuki Nishida, Kohei Kaku
Format: Article
Language:English
Published: Wiley 2021-09-01
Series:Journal of Diabetes Investigation
Subjects:
Online Access:https://doi.org/10.1111/jdi.13525
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spelling 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
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