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

NCT05816057 · Completed

Last updated 2026-05-28

This clinical trial tested whether a semaglutide injection could help lower blood sugar levels in adults with type 2 diabetes over 32 weeks.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 476 people

Who can join Ages 18–75 · all sexes

Timeline Started 2022-07 · est. completion 2023-10

Where 35 sites · China

What this study is testing ClinicalTrials.gov NCT05816057 ↗

Description as written by the study sponsor.

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.

Treatments tested

semaglutide injection Biologic

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.

Main thing measured	The observed mean change in Glycosylated Haemoglobin A1c (HbA1c) values from baseline after 32 weeks of treatment.
Sponsor	Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05816057 ↗