Type 2 DiabetesPhase 3NCT05950516
Efficacy and Safety of Semaglutide Ingection in Subjects With Type 2 Diabetes
A Phase 3 study testing Semaglutide and Semaglutide Pen Injector [Ozempic] in people with Type 2 Diabetes, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the similarity of the efficacy and safety of semaglutide injection (QLG2065) vs. Ozempic® in patients with type 2 diabetes mellitus (T2DM) with poor blood glucose 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
- What is being tested?
- Semaglutide and Semaglutide Pen Injector [Ozempic]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 478 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2023to 22 Jan 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 years and ≤75 years old at the time of screening.
- Subjects diagnosed with type 2 diabetes for at least 6 months (WHO, 1999)
- Within 60 days before screening, subjects received stable treatment with only metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day), or receive combination metformin (dose ≥ 750 mg/day) and another OAD (alpha-glucosidase inhibitors, sulfonylureas, glinides, SGLT-2i or thiazolidinedione), stable treatment is defined as unchanged medication and daily doses;
- At the time of screening, for those who have previously been treated with metformin alone, HbA1c ≥ 7.0% and ≤ 11.0%（local lab）; for those who have previously used metformin in combination with another OAD treatment, HbA1c ≥ 7.0% and ≤10.0%（local lab）;
- BMI≥18.5kg/m2 and ≤35 kg/m2
- Subjects voluntarily participate in this research, can communicate well with researchers, are willing to maintain the same diet and exercise habits throughout the study, and sign an informed consent form (ICF) .
- At baseline，HbAlc ≥ 7.0% and ≤ 11.0%（cental lab）
Who cannot join
- Known or suspected hypersensitivity to any GLP-1RA or related products, or allergic constitution
- Treatment with GLP-1RA, DPP-4 inhibitor, or insulin in a period of 60 days before screening. An exception is short-term insulin therapy (≤7 days in total).
- History of chronic or acute pancreatitis
- Screening calcitonin value ≥ 50 ng/L (pg/mL)
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
- Have a history of major cardiovascular and cerebrovascular diseases within 90 days before screening.
- Known proliferative retinopathy or maculopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Semaglutide Injection (QLG2065) vs. Ozempic® as add-on to Metformin in Type 2 Diabetics.
To evaluate the similarity of the efficacy and safety of semaglutide injection (QLG2065) vs. Ozempic® in patients with type 2 diabetes mellitus (T2DM) with poor blood glucose control after metformin treatment.
- Conditions
- Type 2 Diabetes
- Being tested
- Semaglutide, Semaglutide Pen Injector [Ozempic]
- 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.
SemaglutideDrug
Also called QLG2065
Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks
Semaglutide Pen Injector [Ozempic]Drug
Also called Ozempic Injectable Product
Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks
| Study group | Role | What they receive |
|---|---|---|
| QLG2065 | Experimental | Up to 1.0 mg semaglutide (QLG2065)
Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day). Receives: Drug: Semaglutide |
| Ozempic | Active comparator | Up to 1.0 mg semaglutide (Ozempic)
Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day). Receives: Drug: Semaglutide Pen Injector [Ozempic] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change from baseline (week 1) to week 33 in glycosylated haemoglobin (HbA1c) was evaluated
Measured: Week 33
Secondary outcomes (5)
Change in HbA1c
Change from baseline (week 1) to week 21 in glycosylated haemoglobin (HbA1c) was evaluated
Measured: Week 21
Percentage of Participants Who Achieved HbA1c <7.0% , HbA1c ≤6.5%
Percentage of participants who achieved HbA1c < 7.0%, HbA1c ≤6.5% is presented
Measured: Week 21, 33
Change in Fasting Glucose
Change from baseline (week 1) to week 21, 33 in Fasting Glucose was evaluated
Measured: Week 21, 33
Change in Body Weight
Change from baseline (week 1) to week 21, 33 in body weight was evaluated
Measured: Week 21, 33
Percentage of Participants That Achieved Body Weight Loss ≥5%
Percentage of participants losing ≥5% of baseline body weight is presented
Measured: Week 21, 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start10 Jul 2023 (estimated)
- Primary completion24 Nov 2024 (estimated)
- Study completion22 Jan 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 DiabetesStudies of the same condition, open and under way.
- More trials run by Qilu 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
- 478 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiajun Zhao, Principal investigator, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950516
- Sponsor's protocol ID
- QLG2065-301
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 18 Jul 2023
- 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 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Semaglutide Injection (QLG2065) vs. Ozempic® as add-on to Metformin in Type 2 Diabetics.
- ClinicalTrials.gov ID
- NCT05950516
- Acronym / sponsor ID
- QLG2065-301
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 478 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2023 (estimated)
- Primary completion
- 24 Nov 2024 (estimated)
- Study completion
- 22 Jan 2025 (estimated)
- First posted
- 18 Jul 2023 (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.
To evaluate the similarity of the efficacy and safety of semaglutide injection (QLG2065) vs. Ozempic® in patients with type 2 diabetes mellitus (T2DM) with poor blood glucose control after metformin treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLG2065 | Experimental | Drug: SemaglutideUp to 1.0 mg semaglutide (QLG2065) Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day). |
| Ozempic | Active comparator | Drug: Semaglutide Pen Injector [Ozempic]Up to 1.0 mg semaglutide (Ozempic) Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, age ≥ 18 years and ≤75 years old at the time of screening.
- Subjects diagnosed with type 2 diabetes for at least 6 months (WHO, 1999)
- Within 60 days before screening, subjects received stable treatment with only metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day), or receive combination metformin (dose ≥ 750 mg/day) and another OAD (alpha-glucosidase inhibitors, sulfonylureas, glinides, SGLT-2i or thiazolidinedione), stable treatment is defined as unchanged medication and daily doses;
- At the time of screening, for those who have previously been treated with metformin alone, HbA1c ≥ 7.0% and ≤ 11.0%（local lab）; for those who have previously used metformin in combination with another OAD treatment, HbA1c ≥ 7.0% and ≤10.0%（local lab）;
- BMI≥18.5kg/m2 and ≤35 kg/m2
Key exclusion criteria (7 listed)
- Known or suspected hypersensitivity to any GLP-1RA or related products, or allergic constitution
- Treatment with GLP-1RA, DPP-4 inhibitor, or insulin in a period of 60 days before screening. An exception is short-term insulin therapy (≤7 days in total).
- History of chronic or acute pancreatitis
- Screening calcitonin value ≥ 50 ng/L (pg/mL)
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
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 |
|---|---|---|
| SemaglutideAlso: QLG2065Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks | Drug | QLG2065 |
| Semaglutide Pen Injector [Ozempic]Also: Ozempic Injectable ProductUp to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks | Drug | Ozempic |
Primary outcome
Change in HbA1c
Time frame: Week 33
Change from baseline (week 1) to week 33 in glycosylated haemoglobin (HbA1c) was evaluated
5 secondary outcomes
Change in HbA1c
Time frame: Week 21
Percentage of Participants Who Achieved HbA1c <7.0% , HbA1c ≤6.5%
Time frame: Week 21, 33
Change in Fasting Glucose
Time frame: Week 21, 33
Change in Body Weight
Time frame: Week 21, 33
Percentage of Participants That Achieved Body Weight Loss ≥5%
Time frame: Week 21, 33
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- 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.
Jiajun Zhao principal investigator
Shandong Provincial Hospital
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 Semaglutide and Semaglutide Pen Injector [Ozempic] in people with Type 2 Diabetes, run by Qilu 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 7 inclusion and 7 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 18 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuanzheng Han (0531-55821374, chuanzheng2.han@qilu-pharma.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 33). 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 18 Jul 2023.