Efficacy of once‐daily glucagon‐like peptide‐1 receptor agonist lixisenatide as an add‐on treatment to basal insulin in Asian and white adults with type 2 diabetes mellitus: An individual‐level pooled analysis of phase III studies

Abstract Aims/Introduction The prevalence and pathophysiological background of type 2 diabetes mellitus vary across ethnicities, and can affect treatment responses. Adding lixisenatide to basal insulin (BI) in type 2 diabetes mellitus patients has shown improvements in glycated hemoglobin (HbA1c) an...

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Main Authors: Fuqiang Liu, Yuan Liu, Minzhi Liu, Guangyu Wu, Minlu Zhang, Xia Zhang, Nan Cui, Huiqiu Yin, Li Chen
Format: Article
Language:English
Published: Wiley 2021-08-01
Series:Journal of Diabetes Investigation
Subjects:
Online Access:https://doi.org/10.1111/jdi.13504
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author Fuqiang Liu
Yuan Liu
Minzhi Liu
Guangyu Wu
Minlu Zhang
Xia Zhang
Nan Cui
Huiqiu Yin
Li Chen
author_facet Fuqiang Liu
Yuan Liu
Minzhi Liu
Guangyu Wu
Minlu Zhang
Xia Zhang
Nan Cui
Huiqiu Yin
Li Chen
author_sort Fuqiang Liu
collection DOAJ
description Abstract Aims/Introduction The prevalence and pathophysiological background of type 2 diabetes mellitus vary across ethnicities, and can affect treatment responses. Adding lixisenatide to basal insulin (BI) in type 2 diabetes mellitus patients has shown improvements in glycated hemoglobin (HbA1c) and postprandial glycemic (PPG) excursions, without increasing hypoglycemic events. We aim to compare the efficacy of lixisenatide in Asian and white patients inadequately controlled with basal insulin. Materials and Methods An individual‐level pooled analysis of two multi‐national phase III studies, GetGoal‐L and GetGoal‐L‐C, was carried out to assess the efficacy of lixisenatide versus placebo as an add‐on treatment to BI ± metformin in Asian and white patients with type 2 diabetes mellitus. Change in HbA1c, 2‐h PPG and PPG excursion were analyzed, along with possible predictors of glycemic control. Results Pooled data showed that baseline characteristics were similar between Asian and white patients with the exception of bodyweight, body mass index and BI dose being higher in white patients. After 24 weeks, lixisenatide reduced HbA1c in both ethnic groups, with no statistically significant difference between the two groups (Asian patients least squares mean difference −0.49, 95% confidence interval −0.68 to − 0.30 and white patients least squares mean difference −0.45, 95% confidence interval −0.63 to − 0.26; P = 0.6287). Similarly, no significant difference was found in 2‐h PPG reduction between both groups (least squares mean difference for Asian vs white patients: −3.37 vs −3.93; P = 0.3203). Treatment with lixisenatide contributed to HbA1c reduction of −0.56% after adjustment of baseline HbA1c level in Asian patients, and −0.41% in white patients. Conclusions Adding lixisenatide to BI significantly reduced HbA1c and 2‐h PPG levels in both Asian and white participants with type 2 diabetes mellitus. No differences in treatment effect were observed between the two populations.
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spelling doaj.art-fffcb0cdaaaa4cfcac5061e371be5ef12022-12-21T21:49:10ZengWileyJournal of Diabetes Investigation2040-11162040-11242021-08-011281386139410.1111/jdi.13504Efficacy of once‐daily glucagon‐like peptide‐1 receptor agonist lixisenatide as an add‐on treatment to basal insulin in Asian and white adults with type 2 diabetes mellitus: An individual‐level pooled analysis of phase III studiesFuqiang Liu0Yuan Liu1Minzhi Liu2Guangyu Wu3Minlu Zhang4Xia Zhang5Nan Cui6Huiqiu Yin7Li Chen8Department of Endocrinology Qilu Hospital of Shandong University Jinan ChinaDepartment of Endocrinology Qilu Hospital of Shandong University Jinan ChinaBDM Consulting, Inc. Somerset New Jersey USASanofi Investment Co., Ltd. Shanghai ChinaSanofi Investment Co., Ltd. Shanghai ChinaSanofi Investment Co., Ltd. Shanghai ChinaSanofi Investment Co., Ltd. Shanghai ChinaSanofi Investment Co., Ltd. Shanghai ChinaDepartment of Endocrinology Qilu Hospital of Shandong University Jinan ChinaAbstract Aims/Introduction The prevalence and pathophysiological background of type 2 diabetes mellitus vary across ethnicities, and can affect treatment responses. Adding lixisenatide to basal insulin (BI) in type 2 diabetes mellitus patients has shown improvements in glycated hemoglobin (HbA1c) and postprandial glycemic (PPG) excursions, without increasing hypoglycemic events. We aim to compare the efficacy of lixisenatide in Asian and white patients inadequately controlled with basal insulin. Materials and Methods An individual‐level pooled analysis of two multi‐national phase III studies, GetGoal‐L and GetGoal‐L‐C, was carried out to assess the efficacy of lixisenatide versus placebo as an add‐on treatment to BI ± metformin in Asian and white patients with type 2 diabetes mellitus. Change in HbA1c, 2‐h PPG and PPG excursion were analyzed, along with possible predictors of glycemic control. Results Pooled data showed that baseline characteristics were similar between Asian and white patients with the exception of bodyweight, body mass index and BI dose being higher in white patients. After 24 weeks, lixisenatide reduced HbA1c in both ethnic groups, with no statistically significant difference between the two groups (Asian patients least squares mean difference −0.49, 95% confidence interval −0.68 to − 0.30 and white patients least squares mean difference −0.45, 95% confidence interval −0.63 to − 0.26; P = 0.6287). Similarly, no significant difference was found in 2‐h PPG reduction between both groups (least squares mean difference for Asian vs white patients: −3.37 vs −3.93; P = 0.3203). Treatment with lixisenatide contributed to HbA1c reduction of −0.56% after adjustment of baseline HbA1c level in Asian patients, and −0.41% in white patients. Conclusions Adding lixisenatide to BI significantly reduced HbA1c and 2‐h PPG levels in both Asian and white participants with type 2 diabetes mellitus. No differences in treatment effect were observed between the two populations.https://doi.org/10.1111/jdi.13504Glucagon‐like peptide‐1 receptor agonistLixisenatidePooled analysis
spellingShingle Fuqiang Liu
Yuan Liu
Minzhi Liu
Guangyu Wu
Minlu Zhang
Xia Zhang
Nan Cui
Huiqiu Yin
Li Chen
Efficacy of once‐daily glucagon‐like peptide‐1 receptor agonist lixisenatide as an add‐on treatment to basal insulin in Asian and white adults with type 2 diabetes mellitus: An individual‐level pooled analysis of phase III studies
Journal of Diabetes Investigation
Glucagon‐like peptide‐1 receptor agonist
Lixisenatide
Pooled analysis
title Efficacy of once‐daily glucagon‐like peptide‐1 receptor agonist lixisenatide as an add‐on treatment to basal insulin in Asian and white adults with type 2 diabetes mellitus: An individual‐level pooled analysis of phase III studies
title_full Efficacy of once‐daily glucagon‐like peptide‐1 receptor agonist lixisenatide as an add‐on treatment to basal insulin in Asian and white adults with type 2 diabetes mellitus: An individual‐level pooled analysis of phase III studies
title_fullStr Efficacy of once‐daily glucagon‐like peptide‐1 receptor agonist lixisenatide as an add‐on treatment to basal insulin in Asian and white adults with type 2 diabetes mellitus: An individual‐level pooled analysis of phase III studies
title_full_unstemmed Efficacy of once‐daily glucagon‐like peptide‐1 receptor agonist lixisenatide as an add‐on treatment to basal insulin in Asian and white adults with type 2 diabetes mellitus: An individual‐level pooled analysis of phase III studies
title_short Efficacy of once‐daily glucagon‐like peptide‐1 receptor agonist lixisenatide as an add‐on treatment to basal insulin in Asian and white adults with type 2 diabetes mellitus: An individual‐level pooled analysis of phase III studies
title_sort efficacy of once daily glucagon like peptide 1 receptor agonist lixisenatide as an add on treatment to basal insulin in asian and white adults with type 2 diabetes mellitus an individual level pooled analysis of phase iii studies
topic Glucagon‐like peptide‐1 receptor agonist
Lixisenatide
Pooled analysis
url https://doi.org/10.1111/jdi.13504
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