Efficacy and Safety of Semaglutide Injection vs Ozempic in Patients With Type 2 Diabetes
Status:
COMPLETED
Trial end date:
2025-02-21
Target enrollment:
Participant gender:
Summary
This is a 32-week randomized, open-label, parallel-controlled biosimilar comparison study comparing the efficacy, safety and immunogenicity of the investigational drug and the active comparator in patients with type 2 diabetes mellitus who have inadequate glycemic control with metformin. Eligible participants will be screened and randomized to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or Ozempic injection abdominal subcutaneous injection will be given according to their groups weekly for 32 weeks. Follow-up for 4 weeks after administration.
Trial product will be add-on to subject's stable pre-trial metformin.
The study included a screening period (up to 2 weeks), run-in period6 weeksbaseline, administration period(32 weeks), and a follow-up period (4 weeks). The duration of the study will be approximately 44 weeks for a participant.