Monotherapy with the once weekly GLP-1 receptor agonist dulaglutide for 12 weeks in Japanese patients with type 2 diabetes: dose-dependent effects on glycaemic control in a randomised, double-blind, placebo-controlled study

Endocrine Journal

Masakazu Takeuchi³  Yoichi Satoi¹  Takeshi Imaoka³  Yasuo Terauchi² 

[1] Asia Pacific Statistical Science, Development Center of Excellence, Eli Lilly Japan K.K., Kobe 651-0086, Japan;Department of Endocrinology & Metabolism, Yokohama City University School of Medicine, Yokohama 236-0004, Japan;Medical Science, Eli Lilly Japan K.K, Kobe 651-0086, Japan

关键词: Dulaglutide;    Japanese;    Dose-response;    Type 2 diabetes mellitus;   

DOI  :  10.1507/endocrj.EJ14-0147

学科分类：内分泌与代谢学

来源: Japan Endocrine Society

【 摘 要 】

References(30)Cited-By(12)The aim of this study was to evaluate the dose-dependent effect of dulaglutide, a glucagon-like peptide-1 receptor agonist, on glycaemic control in Japanese patients with type 2 diabetes mellitus who were treated with diet/exercise or oral antidiabetic drug monotherapy.In this randomised, double-blind, placebo-controlled, parallel-group, 12-week study, patients received once weekly subcutaneous dulaglutide doses of 0.25, 0.5, or 0.75 mg (DU 0.25, DU 0.5, and DU 0.75, respectively) or placebo (n=36, 37, 35, and 37, respectively).The primary measure was change from baseline in glycated haemoglobin (HbA1c; %) at 12 weeks.Continuous variables were analysed using a mixed-effects model for repeated measures.Significant dose-dependent reductions in HbA1c were observed (least squares mean difference versus placebo [95% confidence interval]): DU 0.25=-0.72% (-0.95, -0.48), DU 0.5=-0.97% (-1.20, -0.73), and DU 0.75=-1.17% (-1.41, -0.93); p<0.001.Significant improvements in plasma glucose (PG), both fasting and average 7-point self-monitored blood glucose, were also observed with dulaglutide versus placebo (p<0.001).Dulaglutide was well-tolerated.Gastrointestinal adverse events (AEs) were more common in dulaglutide-treated patients, with nausea the most frequent (8 [5.5%]).Few dulaglutide-treated patients discontinued due to AEs (4 [3.7%]), and no serious AEs related to study medication occurred.Three patients (DU 0.5=1 and DU 0.75=2) reported asymptomatic hypoglycaemia (PG ≤70 mg/dL).The observed dose-dependent reduction in HbA1c and acceptable safety profile support further clinical development of dulaglutide for treatment of type 2 diabetes mellitus in Japan.

【 授权许可】

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