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 |
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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 |
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ISSN: | 1462-8902 1463-1326 |
DOI: | 10.1111/dom.15263 |