Type 2 DiabetesPhase 3NCT06739044
Efficacy and Safety of Semaglutide Injection vs Ozempic® in Patients With Type 2 Diabetes
A Phase 3 study testing Ozempic® and HDG1901 in people with Type 2 Diabetes, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Ozempic® and HDG1901
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2023to 21 Feb 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Ozempic®, HDG1901
- Keywords
- Glucagon-Like Peptide-1 Receptor Agonists, semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
HDG1901Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: HDG1901 |
| Active Comparator | Active comparator | Not described Receives: Drug: Ozempic® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline
Measured: Week 32
Secondary outcomes (6)
Change in HbA1c from baseline
Measured: Week 20
Change in Fasting Plasma Glucose(FPG) from baseline
Measured: Week 20， Week 32
HbA1c ≤ 6.5%
Measured: Week 20, Week 32
HbA1c ≤ 7.0%
Measured: Week 20，Week 32
C-peptide
Measured: Week 20, Week 32
Insulin
Measured: Week 20, Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start20 Sep 2023
- Primary completion11 Oct 2024
- Study completion21 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739044
- Sponsor's protocol ID
- HDG1901-301
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06739044
- Acronym / sponsor ID
- HDG1901-301
- Conditions
- Type 2 Diabetes
- Keywords
- Glucagon-Like Peptide-1 Receptor Agonists, semaglutide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: HDG1901 |
| Active Comparator | Active comparator | Drug: Ozempic® |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ozempic®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. | Drug | Active Comparator |
| HDG1901The 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. | Drug | Experimental group |
Primary outcome
Change in HbA1c from baseline
Time frame: Week 32
6 secondary outcomes
Change in HbA1c from baseline
Time frame: Week 20
Change in Fasting Plasma Glucose(FPG) from baseline
Time frame: Week 20， Week 32
HbA1c ≤ 6.5%
Time frame: Week 20, Week 32
HbA1c ≤ 7.0%
Time frame: Week 20，Week 32
C-peptide
Time frame: Week 20, Week 32
Insulin
Time frame: Week 20, Week 32
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ozempic® and HDG1901 in people with Type 2 Diabetes, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c from baseline (time frame: Week 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.