Skip to main content
OpenTrials
Completed

NCT Number: NCT06739044

Efficacy and Safety of Semaglutide Injection vs Ozempic® in Patients With Type 2 Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, age 18-75 years (both inclusive) at the time of signing informed consent
  • Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 6 weeks prior to screening with metformin ≥ 1500 mg (or maximum tolerated dose ≥ 1000 mg)
  • HbA1c 7.5 - 11.0 % (both inclusive) (screening)
  • HbA1c 7.0 - 10.5 % (both inclusive) (randomisation)
  • BMI 18.5-35 kg/m2 (both inclusive)

Exclusion criteria

  • Other types of diabetes besides Type 2 diabetes
  • A history of acute diabetes complications within 6 months before screening
  • A history of acute or chronic pancreatitis, symptomatic gallbladder disease, or other high-risk factors that may lead to pancreatitis
  • Personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
  • Acute coronary or cerebrovascular event within 3 months before screening or randomisation
  • Heart failure, New York Heart Association (NYHA) class IV
  • Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 6 weeks before screening. An exception is short-term treatment (≤7 days in total) with insulin in connection with inter-current illness
  • Fasting Plasma Glucose (FPG) ≥ 13.9mmol/L
  • Screening calcitonin value ≥ 35 ng/L (pg/mL)
  • Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2
  • Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol

Treatment and study plan

Ozempic®

Drug

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.

HDG1901

Drug

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.

Primary outcomes

  1. Change in HbA1c from baseline

    Time frame: Week 32

Secondary outcomes

  1. Change in HbA1c from baseline

    Time frame: Week 20

  2. Change in Fasting Plasma Glucose(FPG) from baseline

    Time frame: Week 20， Week 32

  3. HbA1c ≤ 6.5%

    Time frame: Week 20, Week 32

  4. HbA1c ≤ 7.0%

    Time frame: Week 20，Week 32

  5. C-peptide

    Time frame: Week 20, Week 32

  6. Insulin

    Time frame: Week 20, Week 32

Sponsors and collaborators

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study Comparing the Efficacy and Safety of Semaglutide Injection With Ozempic ® in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With Metformin

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 18, 2024
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.