Efficacy and safety of adding once‐weekly dulaglutide to basal insulin for inadequately controlled type 2 diabetes in Chinese patients ( AWARD‐CHN3 ): A randomized, double‐blind, placebo‐controlled, phase III trial

AimTo determine the efficacy and safety of once‐weekly dulaglutide added to basal insulin in Chinese patients with type 2 diabetes mellitus (T2DM) with inadequate glycaemic control.Materials and MethodsIn the phase III, double‐blind AWARD‐CHN3 study, Chinese patients with T2DM (N = 291) and glycated...

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Veröffentlicht in:Diabetes, obesity & metabolism obesity & metabolism, 2023-12, Vol.25 (12), p.3690-3699
Hauptverfasser: Wang, Weimin, Yan, Xin, Cheng, Zhifeng, Zhang, Qiqi, Wang, Rui, Deng, Yuying, Ma, Jianhua, Zhu, Dalong
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Sprache:eng
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Zusammenfassung:AimTo determine the efficacy and safety of once‐weekly dulaglutide added to basal insulin in Chinese patients with type 2 diabetes mellitus (T2DM) with inadequate glycaemic control.Materials and MethodsIn the phase III, double‐blind AWARD‐CHN3 study, Chinese patients with T2DM (N = 291) and glycated haemoglobin (HbA1c) ≥7.0% and ≤11.0% receiving stable doses of basal insulin glargine with metformin and/or acarbose were randomized (1:1) to receive add‐on dulaglutide 1.5 mg once weekly or placebo once weekly. The primary endpoint was the superiority of dulaglutide/glargine to placebo/glargine for change from baseline in HbA1c at Week 28.ResultsThe least squares (LS) mean ± standard error change in HbA1c from baseline to Week 28 was −2.0 ± 0.08% with dulaglutide/glargine and −1.1 ± 0.07% with placebo/glargine (LS mean difference: −1.0%, 95% confidence interval [CI] –1.1 to −0.8; P 
ISSN:1462-8902
1463-1326
DOI:10.1111/dom.15263