NCT06739044CompletedPhase 3
Efficacy and Safety of Semaglutide Injection vs Ozempic® in Patients With Type 2 Diabetes
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
Source: ClinicalTrials.gov · Last updated 28 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 494 (actual)
- First submitted
- 10 Dec 2024
- Start date
- 20 Sept 2023
- Primary completion date
- 11 Oct 2024
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT06739044
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 494
- From 20 Sept 2023 to the primary completion date, 11 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A history of acute diabetes complications within 6 months before screening
- Acute coronary or cerebrovascular event within 3 months before screening or randomisation
Other illness
- Other types of diabetes besides Type 2 diabetes
- 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)
- Heart failure, New York Heart Association (NYHA) class IV
- Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
Lab values
- 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
- Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2
Other
- Screening calcitonin value ≥ 35 ng/L (pg/mL)
Who the study is looking for
- 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)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.