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

Phase 3

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: Semaglutide Pen Injector [Ozempic]; Drug: Semaglutide

• Registration Number: NCT05950516
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-10
• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-07-11
• Last Update Submitted: 2023-07-11
• Study First Posted: 2023-07-18
• Last Update Posted: 2023-07-18
• Primary Completion: 2024-11-24
• Study Completion: 2025-01-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 478

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ozempic	Semaglutide Pen Injector [Ozempic]	Up to 1.0 mg semaglutide (Ozempic) Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day).
QLG2065	Semaglutide	Up to 1.0 mg semaglutide (QLG2065) Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day).

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	Week 33	Change from baseline (week 1) to week 33 in glycosylated haemoglobin (HbA1c) was evaluated

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c	Week 21	Change from baseline (week 1) to week 21 in glycosylated haemoglobin (HbA1c) 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
Change in Fasting Glucose	Week 21, 33	Change from baseline (week 1) to week 21, 33 in Fasting Glucose 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

Trial Locations

Locations (1)

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China