A Study of the Efficacy and Safety of Semaglutide Injection in the Treatment of Type 2 Diabetes Mellitus

Sponsor
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Study ID
NCT05816057
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • semaglutide injection — BIOLOGICAL
    The subject will receive either a dose semaglutide once weekly (subcutaneous (s.c.) injection). The initial dose of 0.25 mg is s.c. once weekly, and the dose is increased to 0.5 mg after 4 weeks of administration, and the dose is increased to 1 mg after 4 weeks of 0.5 mg administration, and the dose is continued at a stable dose of 1 mg for 24 weeks.Treatment duration 32 weeks.

Study Details

Semaglutide injection is a new drug developed according to Ozempic® biosimilars.This trial is conducted in China. The purpose of this study is to investigate the similarities in the efficacy and safety of semaglutide injection and Ozempic® in the treatment of type 2 diabetes, respectively.

Key Dates

Start date
Jul 25, 2022
Status verified
Jan 2024
Primary completion
Jul 25, 2023
Completion
Oct 31, 2023

Study Design

Enrollment
476 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: semaglutide injection
    Semaglutide 0.25 mg、0.5 mg、1.0mg
  • Active Comparator: ozempic®
    Ozempic® 0.25 mg、0.5 mg、1.0mg

Primary Outcome Measure

The observed mean change in Glycosylated Haemoglobin A1c (HbA1c) values from baseline after 32 weeks of treatment. [ Time Frame: 32 weeks ]

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