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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05950516
• Other study ID #: QLG2065-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 10, 2023
• Est. completion date: January 22, 2025

Study information

• Verified date: July 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Chuanzheng Han
• Phone: 0531-55821374
• Email: chuanzheng2.han[@]qilu-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 478
• Est. completion date: January 22, 2025
• Est. primary completion date: November 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Semaglutide
Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks
• Semaglutide Pen Injector [Ozempic]
Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks

Locations

Country	Name	City	State
China	Shandong Provincial Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Change from baseline (week 1) to week 33 in glycosylated haemoglobin (HbA1c) was evaluated	Week 33
Secondary	Change in HbA1c	Change from baseline (week 1) to week 21 in glycosylated haemoglobin (HbA1c) was evaluated	Week 21
Secondary	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
Secondary	Change in Fasting Glucose	Change from baseline (week 1) to week 21, 33 in Fasting Glucose was evaluated	Week 21, 33
Secondary	Change in Body Weight	Change from baseline (week 1) to week 21, 33 in body weight was evaluated	Week 21, 33
Secondary	Percentage of Participants That Achieved Body Weight Loss =5%	Percentage of participants losing =5% of baseline body weight is presented	Week 21, 33