NCT06739044

Efficacy and Safety of Semaglutide Injection vs Ozempic® in Patients With Type 2 Diabetes

A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study Comparing the Efficacy and Safety of Semaglutide Injection With Ozempic ® in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With Metformin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 494 (actual)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 period（6 weeks），baseline, administration period(32 weeks), and a follow-up period (4 weeks). The duration of the study will be approximately 44 weeks for a participant.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Ozempic®	The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks.
DRUG	HDG1901	The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks.

Timeline

• Start date: 2023-09-20
• Primary completion: 2024-10-11
• Completion: 2025-02-21
• First posted: 2024-12-18
• Last updated: 2025-07-28

Locations

1 site across 1 country: China