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

NCT05816057 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 476

Last updated 2024-01-03

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BIOLOGICAL

semaglutide injection

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.

Sponsors & Collaborators

  • Hangzhou Jiuyuan Gene Engineering Co. Ltd.,

    lead INDUSTRY

Principal Investigators

  • xiaoying Li, M.D. · Shanghai Zhongshan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-25
Primary Completion
2023-07-25
Completion
2023-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05816057 on ClinicalTrials.gov