Type 2 Diabetes MellitusPhase 3NCT06339086
Efficacy and Safety of Semaglutide Injection in Subjects With Type 2 Diabetes
A Phase 3 study testing Semaglutide Injection, Semaglutide Injection(Ozempic®) and Metformin in people with Type 2 Diabetes Mellitus, run by Chengdu Brilliant Pharmaceutical Co., Ltd..
Trial summary
The goal of this clinical trial is to evaluate the similarities in efficacy and safety of semaglutide injection and Ozempic® in patients with type 2 diabetes who have poor glycemic control after metformin treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Semaglutide Injection, Semaglutide Injection(Ozempic®) and Metformin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 478 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to 30 Dec 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
- Voluntarily participate in this study, be able to communicate well with the investigator, understand and voluntarily complete the research process in accordance with this protocol, and sign the Informed Consent Form (ICF).
- Male or female, aged ≥18 and ≤75 years old at the time of signing the ICF.
- Diagnosis of type 2 diabetes for at least 6 months (WHO, 1999) at screening.
- Use a stable dose of metformin for at least 60 days before screening (stable dose of metformin: ≥1500 mg/day or maximum tolerated dose ≥1000 mg/day).
- Glycosylated Hemoglobin(HbA1c) >7.0% and <11.0% at screening (local lab).
- BMI ≥18.5 and ≤35 kg/m2 at screening.
Who cannot join
- Laboratory tests meeting any of the following criteria at screening:
- Calcitonin ≥50ng/L (pg/mL);
- Blood amylase ≥3×ULN (upper limit of normal value);
- Blood lipase ≥3×ULN;
- Triglycerides ≥5.7mmol/L (500mg/dL);
- Alanine aminotransferase ≥3×ULN;
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- Aspartate aminotransferase ≥3×ULN;
- Total bilirubin ≥2×ULN;
- Estimated glomerular filtration rate (eGFR) <60ml/min/1.73m2 (eGFR=175×Scr-1.234 (mg/dl)×age-0.179 (female×0.79), Scr unit conversion: 1mg/dl = 88.4μmol/L).
- Positive HIV antibodies at screening.
- Patients who have received other anti-diabetic drugs other than metformin within 60 days before screening. Such drugs include, but are not limited to, alpha-glycosidase inhibitors (such as acarbose), thiazolidinediones, glucagon-like peptide-1(GLP-1) analogs, dipeptidyl peptidase 4 (DPP-4) inhibitors, except short-term treatment with insulin (cumulative insulin treatment is allowed for ≤7 days within 60 days before screening).
- Patients who have used GLP-1 receptor agonists within 3 months before screening, or have stopped using GLP-1 receptor agonists due to poor safety or efficacy.
- Patients who have used weight loss drugs or have a weight change of more than 5% within 3 months before screening.
- Continuous or cumulative use of systemic glucocorticoids for more than 7 days within 3 months before screening (systemic glucocorticoids: intravenous, oral or intra-articular glucocorticoid treatment).
- Plan to receive glucocorticoids, immunosuppressants, or other drugs (except topical medications and inhaled preparations) that are assessed as unsuitable during the trial by the investigator.
- Those who have participated in other clinical trials and received experimental drugs or placebo intervention within 3 months before screening (except those who only signed the ICF and did not receive any drug or placebo).
- Those who are known to be allergic to the investigational drug or its excipients, or have a history of allergy to GLP-1 drugs, or are in an allergic state at the time of screening, or are unfit for the study due to allergy risks, per investigator's judgment.
- Diagnosis of type 1 diabetes, diabetes caused by pancreatogenic injury or other special types of diabetes.
- Have a history of acute diabetic complications (diabetic ketoacidosis, lactic acidosis or hyperosmolar hyperglycemic state) within 6 months before screening.
- Recurrent (≥3 times) severe hypoglycemia or asymptomatic hypoglycemia events within 6 months before screening.
- Patients who have hemoglobinopathies or hemolytic anemia, have received blood or plasma products within 3 months before screening, or have donated blood or lost more than 400 mL of blood within 3 months before screening.
- History of congestive heart failure: New York Heart Association (NYHA) Class IV.
- Patients who have acute coronary syndrome or cerebrovascular event (except old lacunar infarction) within 3 months before screening, including but not limited to acute myocardial infarction, unstable angina, stroke/transient cerebral ischemia attack, or have undergone heart-related surgery (including coronary artery bypass grafting, percutaneous coronary intervention) within 3 months before screening, or have poor blood pressure control at the time of screening (defined as systolic blood pressure ≥160 millimeter of mercury(mmHg) and /or diastolic blood pressure ≥100 mmHg with antihypertensive drugs) or any other cardiovascular/cerebrovascular diseases that are not suitable for participating in this trial.
- History of proliferative retinopathy or diabetic macular edema, or any other unstable retinopathy (rapidly progressive) recorded in medical history and may require treatment during the study.
- Patients with a history of acute/chronic pancreatitis, symptomatic gallbladder (such as multiple gallbladder stones, excluding cholecystectomy), pancreatic injury, or other conditions that may lead to high risk for pancreatitis.
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
- Diagnosis of malignant tumors within 5 years before screening (except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer).
- Patients who have clinically significant gastric emptying abnormalities (such as severe diabetic gastroparesis, gastric outlet obstruction, etc.), have undergone or plan to undergo surgery that affects gastric emptying during the study period, or have long-term use of drugs that affect gastrointestinal motility.
- Patients with history of alcohol abuse or drug addiction within 6 months before screening; or who have a mental illness (such as depression, etc.) that the may affect participation in the study, in the judgment of the Investigator.
- Uncured active or recurrent bacterial, fungal or viral infection before randomization.
- Females who are pregnant or lactating, or have a positive pregnancy test (woman of childbearing potential).
- During the trial, men and women who have plans to have children or are of childbearing potential but not willing to use effective contraceptive methods.
- In the judgment of the investigator, the patient suffers from diseases that may endanger his or her safety or compliance with the protocol, or other conditions that are not suitable for participation in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Randomized, Open-label and Parallel-controlled Phase III Study to Compare the Efficacy and Safety of Semaglutide Injection With Ozempic® in the Treatment of Type 2 Diabetes Subjects With Poor Glycemic Control on Metformin
The goal of this clinical trial is to evaluate the similarities in efficacy and safety of semaglutide injection and Ozempic® in patients with type 2 diabetes who have poor glycemic control after metformin treatment.
Participants will receive either a dose of semaglutide or Ozempic® once weekly (subcutaneous injection) as add-on to metformin for 32 weeks.
Researchers will compare the outcomes of semaglutide and Ozempic® group to see if the efficacy, safety, pharmacokinetics, and immunogenicity of them are similar.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Semaglutide Injection, Semaglutide Injection(Ozempic®), Metformin
- 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.
Semaglutide InjectionDrug
The subject will receive either a dose of semaglutide subcutaneously once weekly. The initial dose of semaglutide is 0.25mg per week and will be increased to 0.5mg after 4 weeks. After 4 weeks of 0.5mg administration, the dose will be increased to 1mg and continued at a stable does of 1mg for 24 weeks.
Treatment duration 32 weeks.
Semaglutide Injection(Ozempic®)Drug
Also called Ozempic®
The subject will receive either a dose of Ozempic® subcutaneously once weekly. The initial dose of semaglutide is 0.25mg per week and will be increased to 0.5mg after 4 weeks. After 4 weeks of 0.5mg administration, the dose will be increased to 1mg and continued at a stable does of 1mg for 24 weeks.
Treatment duration 32 weeks.
MetforminDrug
Also called Glucophage®
Metformin ≥ 1500mg/day (or maximum tolerated dose ≥ 1000mg/day) and ≤2000mg/day.
Treatment duration 32 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide Injection | Experimental | Semaglutide 0.25mg、0.5mg、1.0mg
Metformin ≥ 1500mg/day (or maximum tolerated dose ≥ 1000mg/day) and ≤2000mg/day Receives: Drug: Semaglutide Injection; Drug: Metformin |
| Ozempic® | Active comparator | Ozempic® 0.25mg、0.5mg、1.0mg
Metformin ≥ 1500mg/day (or maximum tolerated dose ≥ 1000mg/day) and ≤2000mg/day. Receives: Drug: Semaglutide Injection(Ozempic®); Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change from baseline to week 32 in Glycosylated Hemoglobin(HbA1c).
Measured: Week 32
Secondary outcomes (9)
Change in HbA1c
Change from baseline to week 20 in HbA1c.
Measured: Week 20
Change in FPG
Change from baseline to week 20, 32 in Fasting Plasma Glucose(FPG).
Measured: Week 20，32
Proportion of participants who achieved HbA1c<7.0%，HbA1c≤6.5%
Proportion of participants who achieved HbA1c<7.0%，HbA1c≤6.5% at week 20, 32.
Measured: Week 20，32
Proportion of participants who achieved HbA1c<7.0%，HbA1c≤6.5% with no hypoglycemic event
Proportion of participants who achieved HbA1c<7.0%，HbA1c≤6.5% with no confirmed symptomatic hypoglycemic event reported after treatment.
Measured: Week 20，32
Change in Body Weight
Change from baseline to week 20, 32 in Body Weight.
Measured: Week 20，32
Proportion of participants with Weight Loss≥5%, ≥10% and ≥15%
Proportion of participants with Weight Loss≥5%, ≥10% and ≥15% at week 20, 32.
Measured: Week 20，32
Change in Diastolic and Systolic Blood Pressure
Change from baseline to week 32 in Diastolic and Systolic Blood Pressure.
Measured: Week 32
Changes in Blood Lipids
Changes baseline to week 32 in Blood Lipids: Total Cholesterol, Low-density Lipoprotein Cholesterol, High-Density Lipoprotein Cholesterol, and Triglycerides.
Measured: Week 32
Incidence and severity of Adverse Events
Incidence and severity of Adverse Events during treatment.
Measured: Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study startApr 2024 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- 478 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Brilliant Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dalong Zhu, PhD, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339086
- Sponsor's protocol ID
- BPR-201-I-III-01
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- 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 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label and Parallel-controlled Phase III Study to Compare the Efficacy and Safety of Semaglutide Injection With Ozempic® in the Treatment of Type 2 Diabetes Subjects With Poor Glycemic Control on Metformin
- ClinicalTrials.gov ID
- NCT06339086
- Acronym / sponsor ID
- BPR-201-I-III-01
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 478 participants (estimated)
- Lead sponsor
- Chengdu Brilliant Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2024 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 1 Apr 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.
The goal of this clinical trial is to evaluate the similarities in efficacy and safety of semaglutide injection and Ozempic® in patients with type 2 diabetes who have poor glycemic control after metformin treatment.
Participants will receive either a dose of semaglutide or Ozempic® once weekly (subcutaneous injection) as add-on to metformin for 32 weeks.
Researchers will compare the outcomes of semaglutide and Ozempic® group to see if the efficacy, safety, pharmacokinetics, and immunogenicity of them are similar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide Injection | Experimental | Drug: Semaglutide Injection, Drug: MetforminSemaglutide 0.25mg、0.5mg、1.0mg Metformin ≥ 1500mg/day (or maximum tolerated dose ≥ 1000mg/day) and ≤2000mg/day |
| Ozempic® | Active comparator | Drug: Semaglutide Injection(Ozempic®), Drug: MetforminOzempic® 0.25mg、0.5mg、1.0mg Metformin ≥ 1500mg/day (or maximum tolerated dose ≥ 1000mg/day) and ≤2000mg/day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily participate in this study, be able to communicate well with the investigator, understand and voluntarily complete the research process in accordance with this protocol, and sign the Informed Consent Form (ICF).
- Male or female, aged ≥18 and ≤75 years old at the time of signing the ICF.
- Diagnosis of type 2 diabetes for at least 6 months (WHO, 1999) at screening.
- Use a stable dose of metformin for at least 60 days before screening (stable dose of metformin: ≥1500 mg/day or maximum tolerated dose ≥1000 mg/day).
- Glycosylated Hemoglobin(HbA1c) >7.0% and <11.0% at screening (local lab).
Key exclusion criteria (33 listed)
- Laboratory tests meeting any of the following criteria at screening:
- Positive HIV antibodies at screening.
- Patients who have received other anti-diabetic drugs other than metformin within 60 days before screening. Such drugs include, but are not limited to, alpha-glycosidase inhibitors (such as acarbose), thiazolidinediones, glucagon-like peptide-1(GLP-1) analogs, dipeptidyl peptidase 4 (DPP-4) inhibitors, except short-term treatment with insulin (cumulative insulin treatment is allowed for ≤7 days within 60 days before screening).
- Patients who have used GLP-1 receptor agonists within 3 months before screening, or have stopped using GLP-1 receptor agonists due to poor safety or efficacy.
- Patients who have used weight loss drugs or have a weight change of more than 5% within 3 months before screening.
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 |
|---|---|---|
| Semaglutide InjectionThe subject will receive either a dose of semaglutide subcutaneously once weekly. The initial dose of semaglutide is 0.25mg per week and will be increased to 0.5mg after 4 weeks. After 4 weeks of 0.5mg administration, the dose will be increased to 1mg and continued at a stable does of 1mg for 24 weeks. Treatment duration 32 weeks. | Drug | Semaglutide Injection |
| Semaglutide Injection(Ozempic®)Also: Ozempic®The subject will receive either a dose of Ozempic® subcutaneously once weekly. The initial dose of semaglutide is 0.25mg per week and will be increased to 0.5mg after 4 weeks. After 4 weeks of 0.5mg administration, the dose will be increased to 1mg and continued at a stable does of 1mg for 24 weeks. Treatment duration 32 weeks. | Drug | Ozempic® |
| MetforminAlso: Glucophage®Metformin ≥ 1500mg/day (or maximum tolerated dose ≥ 1000mg/day) and ≤2000mg/day. Treatment duration 32 weeks. | Drug | Ozempic®, Semaglutide Injection |
Primary outcome
Change in HbA1c
Time frame: Week 32
Change from baseline to week 32 in Glycosylated Hemoglobin(HbA1c).
9 secondary outcomes
Change in HbA1c
Time frame: Week 20
Change in FPG
Time frame: Week 20，32
Proportion of participants who achieved HbA1c<7.0%，HbA1c≤6.5%
Time frame: Week 20，32
Proportion of participants who achieved HbA1c<7.0%，HbA1c≤6.5% with no hypoglycemic event
Time frame: Week 20，32
Change in Body Weight
Time frame: Week 20，32
Proportion of participants with Weight Loss≥5%, ≥10% and ≥15%
Time frame: Week 20，32
Change in Diastolic and Systolic Blood Pressure
Time frame: Week 32
Changes in Blood Lipids
Time frame: Week 32
Incidence and severity of Adverse Events
Time frame: Week 32
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- 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.
Dalong Zhu, PhD principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide Injection, Semaglutide Injection(Ozempic®) and Metformin in people with Type 2 Diabetes Mellitus, run by Chengdu Brilliant Pharmaceutical Co., Ltd..
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 6 inclusion and 33 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: status not confirmed, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ke Yao (86-028-85142721, ke.yao@btyy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (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 1 Apr 2024.