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

Sponsor
Chengdu Brilliant Pharmaceutical Co., Ltd.
Study ID
NCT06339086
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 30, 2024
Status verified
Mar 2024
Primary completion
Aug 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
478 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide Injection
    Semaglutide 0.25mg、0.5mg、1.0mg Metformin ≥ 1500mg/day (or maximum tolerated dose ≥ 1000mg/day) and ≤2000mg/day
  • Active Comparator: Ozempic®
    Ozempic® 0.25mg、0.5mg、1.0mg Metformin ≥ 1500mg/day (or maximum tolerated dose ≥ 1000mg/day) and ≤2000mg/day.

Primary Outcome Measure

Change in HbA1c [ Time Frame: Week 32 ]

Central Contacts

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