Clinical trial NCT06739044: Efficacy and Safety of Semaglutide Injection Vs Ozempic® in Patients with Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Glucagon-Like Peptide-1 Receptor Agonists
semaglutide
Lead sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-18
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c from baseline
timeFrame: Week 32
Secondary outcomes:
measure: Change in HbA1c from baseline
timeFrame: Week 20
measure: Change in Fasting Plasma Glucose(FPG) from baseline
timeFrame: Week 20， Week 32
measure: HbA1c ≤ 6.5%
timeFrame: Week 20, Week 32
measure: HbA1c ≤ 7.0%
timeFrame: Week 20，Week 32
measure: C-peptide
timeFrame: Week 20, Week 32
measure: Insulin
timeFrame: Week 20, Week 32
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
References: