A Randomized Trial Investigating the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
semaglutide 0.5 mg | no change | semaglutide exposure at steady state [area under the curve (AUC)] | Japanese and Caucasian subjects | - | similar | #1 |
semaglutide 1.0 mg | no change | semaglutide exposure at steady state [area under the curve (AUC)] | Japanese and Caucasian subjects | - | similar | #2 |
semaglutide | no change | pharmacokinetic profile | Japanese and Caucasian subjects | - | similar | #3 |
semaglutide | no change | pharmacodynamic profile | Japanese and Caucasian subjects | - | similar | #4 |
semaglutide | no change | safety profile | Japanese and Caucasian subjects | - | similar | #5 |
INTRODUCTION: Semaglutide is a glucagon-like peptide-1 analogue for once-weekly subcutaneous treatment of type 2 diabetes. This trial compared the pharmacokinetics, pharmacodynamics, and safety of semaglutide in Japanese and Caucasian subjects. METHODS: In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3). The primary endpoint was semaglutide exposure at steady state [area under the curve (AUC RESULTS: Steady-state exposure of semaglutide was similar for both populations: AUC CONCLUSIONS: The pharmacokinetic, pharmacodynamic, and safety profiles of semaglutide were similar in Japanese and Caucasian subjects, suggesting that no dose adjustment is required for the clinical use of semaglutide in Japanese subjects. FUNDING: Novo Nordisk A/S, Denmark. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02146079. Japanese trial registration number JapicCTI-142550.