title: Efficacy and safety analyses across 4 subgroups combining low and high age and body mass index groups in Japanese phase 3 studies of dulaglutide 0.75 mg after 26 weeks of treatment.
abstract: In 855 Japanese patients with type 2 diabetes receiving once weekly dulaglutide 0.75 mg in 3 phase 3 studies, the effects on efficacy and safety at week 26 (last observation carried forward) were investigated in a post hoc descriptive analysis of subgroups of age (<65 years [young], ≥65 years [elderly]) and body mass index (BMI [<25 kg/m2, ≥25 kg/m2]). The 4 subgroups were as follows: 1) the young/low-BMI subgroup (Y/L) (n = 255); 2) the young/high-BMI subgroup (Y/H) (n = 386), 3) the elderly/low-BMI subgroup (E/L) (n = 137), and 4) the elderly/high-BMI subgroup (E/H) (n = 77). The mean changes from baseline in glycated hemoglobin (HbA1c) and body weight, respectively, were -1.69% and -0.29 kg in the Y/L subgroup; -1.48% and -0.09 kg in the Y/H subgroup; -1.68% and -0.20 kg in the E/L subgroup; and -1.72% and -0.26 kg in the E/H subgroup. The incidences of nausea and hypoglycemia, respectively, were 6.7% and 11.0% in the Y/L subgroup; 7.0% and 8.0% in the Y/H subgroup; 10.2% and 18.2% in the E/L subgroup; and 3.9% and 22.1% in the E/H subgroup. Dulaglutide improved HbA1c regardless of age or BMI; a higher incidence of hypoglycemia was observed in elderly patients compared to younger patients.
authors.affiliation: Kanto Rosai Hospital, Kawasaki, Japan.
authors.forename: Kumiko
authors.initials: K
authors.lastname: Hamano
authors.affiliation: Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nishiyama
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: Manaka
authors.initials: M
authors.lastname: Sato
authors.affiliation: Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Masakazu
authors.initials: M
authors.lastname: Takeuchi
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000375:Aging / Q000502:physiology*; D044466:Asian People; D015992:Body Mass Index; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D004763:Glucagon-Like Peptides / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007141:Immunoglobulin Fc Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D008875:Middle Aged; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007141:Immunoglobulin Fc Fragments; D011993:Recombinant Fusion Proteins; D004763:Glucagon-Like Peptides; C555680:dulaglutide
keywords: Dulaglutide; GLP-1 receptor agonist; Subgroup analysis; Type 2 diabetes