Efficacy and Safety of Semaglutide Ingection in Subjects With Type 2 Diabetes
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: QLG2065 Up to 1.0 mg semaglutide (QLG2065) Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day). |
Drug: Semaglutide
Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks
Other Names:
|
| Active Comparator: Ozempic Up to 1.0 mg semaglutide (Ozempic) Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day). |
Drug: Semaglutide Pen Injector [Ozempic]
Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in HbA1c [Week 33]
Change from baseline (week 1) to week 33 in glycosylated haemoglobin (HbA1c) was evaluated
Secondary Outcome Measures
- Change in HbA1c [Week 21]
Change from baseline (week 1) to week 21 in glycosylated haemoglobin (HbA1c) was evaluated
- Percentage of Participants Who Achieved HbA1c <7.0% , HbA1c ≤6.5% [Week 21, 33]
Percentage of participants who achieved HbA1c < 7.0%, HbA1c ≤6.5% is presented
- Change in Fasting Glucose [Week 21, 33]
Change from baseline (week 1) to week 21, 33 in Fasting Glucose was evaluated
- Change in Body Weight [Week 21, 33]
Change from baseline (week 1) to week 21, 33 in body weight was evaluated
- Percentage of Participants That Achieved Body Weight Loss ≥5% [Week 21, 33]
Percentage of participants losing ≥5% of baseline body weight is presented
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female, age ≥ 18 years and ≤75 years old at the time of screening.
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Subjects diagnosed with type 2 diabetes for at least 6 months (WHO, 1999)
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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）;
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BMI≥18.5kg/m2 and ≤35 kg/m2
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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) .
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At baseline，HbAlc ≥ 7.0% and ≤ 11.0%（cental lab）
Exclusion Criteria:
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Known or suspected hypersensitivity to any GLP-1RA or related products, or allergic constitution
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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).
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History of chronic or acute pancreatitis
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Screening calcitonin value ≥ 50 ng/L (pg/mL)
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Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
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Have a history of major cardiovascular and cerebrovascular diseases within 90 days before screening.
-
Known proliferative retinopathy or maculopathy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shandong Provincial Hospital | Jinan | Shandong | China |
Sponsors and Collaborators
- Qilu Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Jiajun Zhao, Shandong Provincial Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QLG2065-301