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

What this study is testing ClinicalTrials.gov NCT06339086 ↗

Description as written by the study sponsor.

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.

Treatments tested

• Semaglutide Injection Drug

  The subject will receive either a dose of semaglutide subcutaneously once weekly. The initial dose of semaglutide is 0.25mg per week and will be increased to 0.5mg after 4 weeks. After 4 weeks of 0.5mg administration, the dose will be increased to 1mg and continued at a stable does of 1mg for 24 weeks. Treatment duration 32 weeks.

• Semaglutide Injection(Ozempic®) also known as Ozempic® Drug

  The subject will receive either a dose of Ozempic® subcutaneously once weekly. The initial dose of semaglutide is 0.25mg per week and will be increased to 0.5mg after 4 weeks. After 4 weeks of 0.5mg administration, the dose will be increased to 1mg and continued at a stable does of 1mg for 24 weeks. Treatment duration 32 weeks.

• Metformin also known as Glucophage® Drug

  Metformin ≥ 1500mg/day (or maximum tolerated dose ≥ 1000mg/day) and ≤2000mg/day. Treatment duration 32 weeks.