Efficacy and Safety of Semaglutide Injection in Subjects With Type 2 Diabetes

NCT06339086 | Not Yet Recruiting Phase 3

• 1 other identifier: BPR-201-I-III-01
• Study Type: interventional
• Target: 478
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate the similarities in efficacy and safety of semaglutide injection and Ozempic® in patients with type 2 diabetes who have poor glycemic control after metformin treatment. Participants will receive either a dose of semaglutide or Ozempic® once weekly (subcutaneous injection) as add-on to metformin for 32 weeks. Researchers will compare the outcomes of semaglutide and Ozempic® group to see if the efficacy, safety, pharmacokinetics, and immunogenicity of them are similar.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change from baseline to week 32 in Glycosylated Hemoglobin(HbA1c).

  Week 32

Secondary Outcomes (9)

• Change in HbA1c

  Week 20

• Change in FPG

  Week 20，32

• Proportion of participants who achieved HbA1c<7.0%，HbA1c≤6.5%

  Week 20，32

• Proportion of participants who achieved HbA1c<7.0%，HbA1c≤6.5% with no hypoglycemic event

  Week 20，32

• Change in Body Weight

  Week 20，32

Study Arms (2)

Semaglutide Injection

EXPERIMENTAL

Semaglutide 0.25mg、0.5mg、1.0mg Metformin ≥ 1500mg/day (or maximum tolerated dose ≥ 1000mg/day) and ≤2000mg/day

Drug: Semaglutide Injection; Drug: Metformin

Ozempic®

ACTIVE COMPARATOR

Ozempic® 0.25mg、0.5mg、1.0mg Metformin ≥ 1500mg/day (or maximum tolerated dose ≥ 1000mg/day) and ≤2000mg/day.

Drug: Semaglutide Injection(Ozempic®); Drug: Metformin

Interventions

Semaglutide Injection DRUG

The subject will receive either a dose of semaglutide subcutaneously once weekly. The initial dose of semaglutide is 0.25mg per week and will be increased to 0.5mg after 4 weeks. After 4 weeks of 0.5mg administration, the dose will be increased to 1mg and continued at a stable does of 1mg for 24 weeks. Treatment duration 32 weeks.

Semaglutide Injection

Semaglutide Injection(Ozempic®) DRUG

The subject will receive either a dose of Ozempic® subcutaneously once weekly. The initial dose of semaglutide is 0.25mg per week and will be increased to 0.5mg after 4 weeks. After 4 weeks of 0.5mg administration, the dose will be increased to 1mg and continued at a stable does of 1mg for 24 weeks. Treatment duration 32 weeks.

Also known as: Ozempic®

Ozempic®

Metformin DRUG

Metformin ≥ 1500mg/day (or maximum tolerated dose ≥ 1000mg/day) and ≤2000mg/day. Treatment duration 32 weeks.

Also known as: Glucophage®

Ozempic®; Semaglutide Injection

Eligibility Criteria

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

You may qualify if:

• Voluntarily participate in this study, be able to communicate well with the investigator, understand and voluntarily complete the research process in accordance with this protocol, and sign the Informed Consent Form (ICF).
• Male or female, aged ≥18 and ≤75 years old at the time of signing the ICF.
• Diagnosis of type 2 diabetes for at least 6 months (WHO, 1999) at screening.
• Use a stable dose of metformin for at least 60 days before screening (stable dose of metformin: ≥1500 mg/day or maximum tolerated dose ≥1000 mg/day).
• Glycosylated Hemoglobin(HbA1c) \>7.0% and \<11.0% at screening (local lab).
• BMI ≥18.5 and ≤35 kg/m2 at screening.

You may not qualify if:

• Laboratory tests meeting any of the following criteria at screening:
• Calcitonin ≥50ng/L (pg/mL);
• Blood amylase ≥3×ULN (upper limit of normal value);
• Blood lipase ≥3×ULN;
• Triglycerides ≥5.7mmol/L (500mg/dL);
• Alanine aminotransferase ≥3×ULN;
• Aspartate aminotransferase ≥3×ULN;
• Total bilirubin ≥2×ULN;
• Estimated glomerular filtration rate (eGFR) \<60ml/min/1.73m2 (eGFR=175×Scr-1.234 (mg/dl)×age-0.179 (female×0.79), Scr unit conversion: 1mg/dl = 88.4μmol/L).
• Positive HIV antibodies at screening.
• Patients who have received other anti-diabetic drugs other than metformin within 60 days before screening. Such drugs include, but are not limited to, alpha-glycosidase inhibitors (such as acarbose), thiazolidinediones, glucagon-like peptide-1(GLP-1) analogs, dipeptidyl peptidase 4 (DPP-4) inhibitors, except short-term treatment with insulin (cumulative insulin treatment is allowed for ≤7 days within 60 days before screening).
• Patients who have used GLP-1 receptor agonists within 3 months before screening, or have stopped using GLP-1 receptor agonists due to poor safety or efficacy.
• Patients who have used weight loss drugs or have a weight change of more than 5% within 3 months before screening.
• Continuous or cumulative use of systemic glucocorticoids for more than 7 days within 3 months before screening (systemic glucocorticoids: intravenous, oral or intra-articular glucocorticoid treatment).
• Plan to receive glucocorticoids, immunosuppressants, or other drugs (except topical medications and inhaled preparations) that are assessed as unsuitable during the trial by the investigator.

Sponsors & Collaborators

• Chengdu Brilliant Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Dalong Zhu, PhD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke Yao

CONTACT

86-028-85142721; ke.yao@btyy.com

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: March 18, 2024
• First Posted: April 1, 2024
• Study Start: April 1, 2024
• Primary Completion: August 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share