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← All trials/NCT05950516

UnknownPhase 3

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.

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Estimated enrollment

478

Study population

Type 2 diabetes

Eligibility highlights

BMI 18.5-35HbA1c 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

NCT IDNCT05950516
Org study IDQLG2065-301

Timeline

Milestones

Study start2023-07-10estimated
Study first posted2023-07-18actual
Last update posted2023-07-18actual
Primary completion2024-11-24estimated
Study completion2025-01-22estimated

Assets

Investigational agents

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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

Glycemic / diabetes
4
Weight & body composition
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change in Body Weight

Time frame:Week 21, 33

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants That Achieved Body Weight Loss ≥5%

Time frame:Week 21, 33

≥5% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Change in HbA1c

Time frame:Week 33

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c

Time frame:Week 21

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Change in Fasting Glucose

Time frame:Week 21, 33

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.