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Phase 3Completed

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

Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (Industry)
Enrollment
494 enrolled
Conditions
Type 2 Diabetes
Interventions
Ozempic®; HDG1901
Ages
adults, older adults
Registry
NCT06739044

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Change in HbA1c from baseline

History

  1. Last registry update

  2. Study completion

  3. Registered

  4. Primary completion

  5. Started

Papers citing this trial