title: 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.
abstract: 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.
authors.affiliation: The Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan.
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Onishi
authors.affiliation: Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Oura
authors.affiliation: Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Akiko
authors.initials: A
authors.lastname: Matsui
authors.affiliation: Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Matsuura
authors.affiliation: Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Iwamoto
mesh_terms: D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D004763:Glucagon-Like Peptides / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007141:Immunoglobulin Fc Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D000069036:Insulin Glargine / Q000009:adverse effects / Q000627:therapeutic use; D007564:Japan; D000069450:Liraglutide / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D012737:Sex Factors; D016896:Treatment Outcome
chemical_list: D007004:Hypoglycemic Agents; D007141:Immunoglobulin Fc Fragments; D011993:Recombinant Fusion Proteins; D000069036:Insulin Glargine; D004763:Glucagon-Like Peptides; D000069450:Liraglutide; C555680:dulaglutide
keywords: Dulaglutide; GLP-1 receptor agonist; Sex; Subgroup analysis; Type 2 diabetes