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

Hangzhou Zhongmei Huadong Pharmaceutical

Status and phase: Active, not recruiting; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Ozempic®; Drug: HDG1901

Study type: Interventional

Funder types: Industry

Identifiers

NCT06739044

HDG1901-301

Details and patient eligibility

About

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.

Enrollment: 494 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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494 participants in 2 patient groups

Experimental group

Experimental group

Treatment:

Drug: HDG1901

Active Comparator

Active Comparator group

Treatment:

Drug: Ozempic®