Efficacy and Safety of Semaglutide Ingection in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Semaglutide Injection (QLG2065) vs. Ozempic® as add-on to Metformin in Type 2 Diabetics.

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Semaglutide
* Drug: Semaglutide Pen Injector [Ozempic]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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） Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QLG2065<br>Up to 1.0 mg semaglutide (QLG2065) Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day). | Drug: Semaglutide<br>* Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks<br>* Other names: QLG2065;|
| Active Comparator: Ozempic<br>Up to 1.0 mg semaglutide (Ozempic) Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day). | Drug: Semaglutide Pen Injector [Ozempic]<br>* Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks<br>* Other names: Ozempic Injectable Product;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | Change from baseline (week 1) to week 33 in glycosylated haemoglobin (HbA1c) was evaluated | Week 33 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | Change from baseline (week 1) to week 21 in glycosylated haemoglobin (HbA1c) was evaluated | 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 | Week 21, 33 | 
| Change in Fasting Glucose | Change from baseline (week 1) to week 21, 33 in Fasting Glucose was evaluated | Week 21, 33 | 
| Change in Body Weight | Change from baseline (week 1) to week 21, 33 in body weight was evaluated | Week 21, 33 | 
| Percentage of Participants That Achieved Body Weight Loss ≥5% | Percentage of participants losing ≥5% of baseline body weight is presented | Week 21, 33 |