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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
494
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.
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.
Beijing Hospital
Beijing, Beijing Municipality, China
Change in HbA1c from baseline
Time frame: Week 32
Change in HbA1c from baseline
Time frame: Week 20
Change in Fasting Plasma Glucose(FPG) from baseline
Time frame: Week 20, Week 32
HbA1c ≤ 6.5%
Time frame: Week 20, Week 32
HbA1c ≤ 7.0%
Time frame: Week 20,Week 32
C-peptide
Time frame: Week 20, Week 32
Insulin
Time frame: Week 20, Week 32
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