Efficacy and Safety of Semaglutide Ingection in Subjects With Type 2 Diabetes
Efficacy and Safety of Semaglutide Injection (QLG2065) vs. Ozempic® as add-on to Metformin in Type 2 Diabetics.
Lead sponsor
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
-
Estimated enrollment
478
Study population
Type 2 diabetes
Eligibility highlights
•BMI 18.5-35•HbA1c 7-11%
Primary endpoint
•HbA1c, change
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
1. Male or female, age ≥ 18 years and ≤75 years old at the time of screening.
2. Subjects diagnosed with type 2 diabetes for at least 6 months (WHO, 1999)
3. 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;
4. 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);
5. BMI≥18.5kg/m2 and ≤35 kg/m2
6. 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) .
7. At baseline,HbAlc ≥ 7.0% and ≤ 11.0%(cental lab)
Exclusion criteria
1. Known or suspected hypersensitivity to any GLP-1RA or related products, or allergic constitution
2. 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).
3. History of chronic or acute pancreatitis
4. Screening calcitonin value ≥ 50 ng/L (pg/mL)
5. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
6. Have a history of major cardiovascular and cerebrovascular diseases within 90 days before screening.
7. Known proliferative retinopathy or maculopathy
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsChange in Body Weight
Time frame:Week 21, 33
Body weight, absolute change (kg)
change from baseline, improvement
Percentage of Participants That Achieved Body Weight Loss ≥5%
Time frame:Week 21, 33
≥5% weight-loss responders
threshold achievement, improvement
Glycemic / diabetes
4 endpointsChange in HbA1c
Time frame:Week 33
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in HbA1c
Time frame:Week 21
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Percentage of Participants Who Achieved HbA1c <7.0% , HbA1c ≤6.5%
Time frame:Week 21, 33
threshold achievement, improvement
componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement
Change in Fasting Glucose
Time frame:Week 21, 33
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.