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

NCT06739044 | Completed Phase 3

• 1 other identifier: HDG1901-301
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Glucagon-Like Peptide-1 Receptor Agonists; semaglutide

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c from baseline

  Week 32

Secondary Outcomes (6)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

Drug: HDG1901

Active Comparator

ACTIVE COMPARATOR

Drug: Ozempic®

Interventions

Ozempic® DRUG

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

HDG1901 DRUG

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18-75 years (both inclusive) at the time of signing informed consent
• 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)
• HbA1c 7.5 - 11.0 % (both inclusive) (screening)
• HbA1c 7.0 - 10.5 % (both inclusive) (randomisation)
• BMI 18.5-35 kg/m2 (both inclusive)

You may not qualify if:

• Other types of diabetes besides Type 2 diabetes
• A history of acute diabetes complications within 6 months before screening
• A history of acute or chronic pancreatitis, symptomatic gallbladder disease, or other high-risk factors that may lead to pancreatitis
• Personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
• Acute coronary or cerebrovascular event within 3 months before screening or randomisation
• Heart failure, New York Heart Association (NYHA) class IV
• Fasting Plasma Glucose (FPG) ≥ 13.9mmol/L
• Screening calcitonin value ≥ 35 ng/L (pg/mL)
• Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2
• Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol

Sponsors & Collaborators

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

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 18, 2024
• Study Start: September 20, 2023
• Primary Completion: October 11, 2024
• Study Completion: February 21, 2025
• Last Updated: July 28, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)