Analysis of efficacy and safety of dulaglutide 0.75 mg stratified by sex in patients with type 2 diabetes in 2 randomized, controlled phase 3 studies in Japan

Endocrine journal

Tomonori Oura¹  Akiko Matsui¹  Noriyuki Iwamoto¹  Jun Matsuura¹  Yukiko Onishi² 

[1] Eli Lilly Japan K.K., Kobe, Japan;The Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan

关键词: Dulaglutide;    GLP-1 receptor agonist;    Sex;    Subgroup analysis;    Type 2 diabetes;   

DOI  :  10.1507/endocrj.EJ16-0552

学科分类：内分泌与代谢学

来源: Japan Endocrine Society

【 摘 要 】

We analyzed the efficacy and safety of once weekly dulaglutide 0.75 mg by sex in 2 randomized, controlled phase 3 studies in Japanese patients with type 2 diabetes (a 52-week monotherapy study [comparator liraglutide 0.9 mg] and a 26-week combination therapy study [comparator insulin glargine]).Females comprised 18% of patients in the monotherapy study and 29% of patients in the combination therapy study.Mean reductions from baseline in glycated hemoglobin (HbA1c) were similar between the sexes for dulaglutide- and liraglutide-treated patients (range -1.17% to -1.49%).Females had numerically greater weight loss or less weight gain than males across all treatment groups.The percentages of patients with reductions in both HbA1c and weight from baseline were also greater for females than for males in all treatment groups.In all treatment groups, the incidences of treatment-emergent adverse events tended to be greater among females than among males.No differences in the incidences of total or nocturnal hypoglycemia were observed between the sexes in any treatment group.Overall, in 2 studies in Japan, across all treatment groups it appeared that HbA1c lowering was unaffected by patient sex, while female patients had greater weight loss or less weight gain and greater incidence of adverse events, including nausea, compared to male patients.Incidences of patients discontinuing dulaglutide early due to adverse event were low (<10%) for both sexes, and no new safety concerns related to dulaglutide were identified for either sex.Therefore, the benefit/risk ratio for dulaglutide remains unchanged, positive for both sexes.

【 授权许可】

Unknown