Efficacy and Safety of Semaglutide Injection vs Ozempic® in Patients With Type 2 Diabetes

A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study Comparing the Efficacy and Safety of Semaglutide Injection With Ozempic ® in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With Metformin

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: HDG1901; Drug: Ozempic®

• Study Type: Interventional
• Enrollment (Actual): 494
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Hospital

Participation Criteria

Eligibility Criteria

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

Description

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 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: Experimental group	Drug: HDG1901; The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks.
Active Comparator: Active Comparator	Drug: Ozempic®; The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c from baseline	Week 32

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c from baseline	Week 20
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

Collaborators and Investigators

• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Actual): October 11, 2024
• Study Completion (Actual): February 21, 2025

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: semaglutide; Glucagon-Like Peptide-1 Receptor Agonists
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; Semaglutide
• Other Study ID Numbers: HDG1901-301

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
• product manufactured in and exported from the U.S.: No