Efficacy and Safety of Semaglutide Injection Vs Ozempic® in Patients with Type 2 Diabetes

Phase 3

Active, not recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: Ozempic®; Drug: HDG1901

• Registration Number: NCT06739044
• Lead Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Brief Summary

This is a 32-week randomized, open-label, parallel-controlled biosimilar comparison study comparing the efficacy, safety and immunogenicity of the investigational drug and the active comparator in patients with type 2 diabetes mellitus who have inadequate glycemic control with metformin. Eligible participants will be screened and randomized to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or Ozempic® injection abdominal subcutaneous injection will be given according to their groups weekly for 32 weeks. Follow-up for 4 weeks after administration.

Trial product will be add-on to subject's stable pre-trial metformin.

The study included a screening period (up to 2 weeks), run-in period（6 weeks），baseline, administration period(32 weeks), and a follow-up period (4 weeks). The duration of the study will be approximately 44 weeks for a participant.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-20
• Primary Completion: 2024-10-11
• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Study Completion: 2025-02-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 494

Inclusion Criteria

1. Male or female, age 18-75 years (both inclusive) at the time of signing informed consent
2. Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 6 weeks prior to screening with metformin ≥ 1500 mg (or maximum tolerated dose ≥ 1000 mg)
3. HbA1c 7.5 - 11.0 % (both inclusive) (screening)
4. HbA1c 7.0 - 10.5 % (both inclusive) (randomisation)
5. BMI 18.5-35 kg/m2 (both inclusive)

Exclusion Criteria

1. Other types of diabetes besides Type 2 diabetes
2. A history of acute diabetes complications within 6 months before screening
3. A history of acute or chronic pancreatitis, symptomatic gallbladder disease, or other high-risk factors that may lead to pancreatitis
4. Personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
5. Acute coronary or cerebrovascular event within 3 months before screening or randomisation
6. Heart failure, New York Heart Association (NYHA) class IV
7. Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 6 weeks before screening. An exception is short-term treatment (≤7 days in total) with insulin in connection with inter-current illness
8. Fasting Plasma Glucose (FPG) ≥ 13.9mmol/L
9. Screening calcitonin value ≥ 35 ng/L (pg/mL)
10. Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2
11. Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator	Ozempic®	-
Experimental group	HDG1901	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline	Week 32

Secondary Outcome Measures

Name	Time	Method
Change in Fasting Plasma Glucose(FPG) from baseline	Week 20， Week 32
HbA1c ≤ 6.5%	Week 20, Week 32
HbA1c ≤ 7.0%	Week 20，Week 32
C-peptide	Week 20, Week 32
Insulin	Week 20, Week 32
Change in HbA1c from baseline	Week 20

Trial Locations

Locations (1)

Beijing Hospital; 🇨🇳 Beijing, Beijing, China