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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Semaglutide; Drug: Semaglutide Pen Injector [Ozempic]

• Study Type: Interventional
• Enrollment (Estimated): 478
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Chuanzheng Han; Phone Number: 0531-55821374; Email: chuanzheng2.han@qilu-pharma.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Shandong Provincial Hospital
      • Contact: Jiajun Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Jiajun Zhao, Shandong Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2023
• Primary Completion (Estimated): November 24, 2024
• Study Completion (Estimated): January 22, 2025

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: QLG2065-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No