Pharmacokinetic and Pharmacodynamic Properties of Once-Weekly Insulin Efsitora Alfa in Japanese Patients with Type 2 Diabetes.

• Tác giả: Kenichi Furihata, Makoto Imori, Risa Nasu, Kenji Ohwaki, Tomonori Oura
• Ngôn ngữ: eng
• Thông tin xuất bản: United States : Diabetes therapy : research, treatment and education of diabetes and related disorders , 2025
• Bộ sưu tập: NCBI
• ID: 679845

Tóm tắt

 INTRODUCTION: This analysis aimed to assess the safety and tolerability of insulin efsitora alfa (efsitora, basal insulin Fc, LY3209590) and characterize the pharmacokinetic and pharmacodynamic profiles of efsitora in Japanese patients with type 2 diabetes. METHODS: The single-dose escalation study assessed once-weekly efsitora administration in three patient cohorts: 5 mg for cohort 1
  10 mg for cohort 2 or placebo under double-blind conditions
  and 20 mg for cohort 3 under open-label conditions. In the 6-week, multiple-dose study, patients started or continued using insulin degludec during the lead-in period, followed by randomization to efsitora (individualized fixed weekly dose) or insulin degludec (individualized fixed daily dose). Pharmacokinetics, pharmacodynamics, and safety were examined. RESULTS: The mean age was 58.3 and 58.4 years, and mean body mass index was 25.6 and 26.8 kg/m CONCLUSIONS: Efsitora was well tolerated, and the pharmacokinetic and pharmacodynamic profiles were consistent with findings in prior global studies, supporting the participation of Japanese patients in phase 3 studies. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03603704
  NCT04276428.