drugset / Trial / NCT06339086

Efficacy and Safety of Semaglutide Injection in Subjects With Type 2 Diabetes

NCT06339086

Phase 3 Unknown 478 enrolled Chengdu Brilliant Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to evaluate the similarities in efficacy and safety of semaglutide injection and Ozempic® in patients with type 2 diabetes who have poor glycemic control after metformin treatment. Participants will receive either a dose of semaglutide or Ozempic® once weekly (subcutaneous injection) as add-on to metformin for 32 weeks. Researchers will compare the outcomes of semaglutide and Ozempic® group to see if the efficacy, safety, pharmacokinetics, and immunogenicity of them are similar.

Timeline

Start
2024-04
Primary completion
2025-08-30
Completion
2025-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Semaglutide Peptide 1 mg Subcutaneous
Background Metformin Small molecule 1000 mg
Background Metformin Small molecule 1500 mg
Background Metformin Small molecule 2000 mg