Efficacy and Safety of Semaglutide Injection (HD1916) in Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase 3, Randomized, Open-label, Parallel-group, Multicenter, Controlled Study to Evaluate Efficacy and Safety of Semaglutide Injection (HD1916) vs. Ozempic® as add-on to Metformin in Patients With Type 2 Diabetics Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06161844
• Other study ID #: HD1916-002
• Status: Recruiting
• Phase: Phase 3
• Start date: February 23, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: December 2023
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: Clinical Trials Information Group officer
• Phone: 86-0311-69085587
• Email: ctr-contact[@]cspc.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the similarity of the efficacy and safety of semaglutide injection (HD1916) vs. Ozempic® in patients with type 2 diabetes mellitus (T2DM) with poor blood glucose control after metformin treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 588
• Est. completion date: February 28, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female, age = 18 years and =75 years old;

2. Patients diagnosed with type 2 diabetes;

3. A stable dose of metformin hydrochloride is administered on the basis of diet and exercise before screening (the minimum dose of metformin hydrochloride should meet the following requirements: metformin hydrochloride dose =1500 mg/ day, or at least =1000 mg/ day if the maximum tolerated dose has been reached according to the participant's medical record); the treatment lasted for =8 weeks;

4. At the time of screening, HbA1c = 7.5% and = 11.0% (local lab); At baseline, HbA1c = 7.0% and =10.5% (central lab);

5. At the time of screening, BMI=18.5 kg/m^2 and =35 kg/m^2;

6. The patient of potential fertility is willing and must use a reliable contraceptive method to avoid pregnancy of the female patient or the male patient's partner during the whole study period and for at least 3 months after the last dose;

7. The patient is able to understand the informed consent form, voluntarily participate in the trial and sign the informed consent form.

Exclusion Criteria:

1. Patients with type 1 diabetes or other special types of diabetes;

2. Treatment with any glucose-lowering agent other than metformin hydrochloride within 8 weeks before screening or during the screening/run-in period (=7 total days allowed in the 8 weeks before screening) or use of GLP-1 or a dual - or multi-target agent containing GLP-1 within the past 3 months;

3. Patients who meet the contraindications of GLP-1 RA drugs and metformin hydrochloride drugs;

4. Known allergy to the investigational drugs or excipients;

5. Acute metabolic complications within 6 months before screening, including but not limited to: diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), or lactic acidosis;

6. Have serious chronic diabetic complications, including but not limited to:

proliferative diabetic retinopathy, severe nonproliferative diabetic retinopathy, suspected or confirmed history of macular edema, history of renal dialysis or renal transplantation, severe peripheral vascular disease (such as amputation, chronic foot ulcers, intermittent claudication, etc.), or significant autonomic neuropathy (such as urinary retention, orthostatic hypotension, diabetic diarrhea, etc.);

7. A history of two or more episodes of grade 3 hypoglycemia within 6 months before screening or grade 3 hypoglycemia (grade 3: a severe hypoglycemic event that requires assistance from another person for treatment, with altered consciousness, physical appearance, but without a specific glycemic cutoff) before screening to randomization;

8. Stress conditions such as severe trauma, acute infection or major surgery under general anesthesia that may affect blood glucose levels within 1 month before screening or during screening/induction;

9. Patients with hyperthyroidism or hypothyroidism at screening (except those with stable drug dose control for more than 3 months and normal thyroid function tests) or clinically significant abnormal thyroid function test results at screening and requiring drug treatment;

10. Patients with obvious blood system diseases that may cause hemolysis or red blood cell instability and affect HbA1c detection, including but not limited to: hemolytic anemia, aplastic anemia, myelodysplastic syndrome, etc., or blood donation or blood loss =400 mL within 4 weeks before screening, or receiving blood transfusion;

11. Have undergone metabolic surgery prior to screening, or had used medications and/or supplements with approved weight-loss indications within 3 months;

12. Patients with severe heart disease or cardiac insufficiency. Including, but not limited to, decompensated heart failure (NYHA class ? or ?); Uncontrolled or severe arrhythmia; Patients have a history of acute myocardial infarction, unstable angina pectoris, or coronary stent implantation, coronary artery bypass grafting, or coronary angioplasty within 6 months before screening;

13. Patients with incident cerebrovascular events (including, but not limited to, ischemic stroke, hemorrhagic stroke, and transient ischemic attack) within 6 months prior to screening;

14. Uncontrolled hypertension (defined as systolic blood pressure =160mmHg and/or diastolic blood pressure =100mmHg), or hypotension (blood pressure < 90/60mmHg at screening);

15. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) at screening;

16. Patients with a history of severe chronic gastrointestinal disease, clinically significant abnormal gastric emptying (e.g., diabetic gastroparesis, pyloric stenosis, etc.), long-term use of drugs that directly reduce gastrointestinal peristalsis, or those who have undergone gastrointestinal resection;

17. Patients with a history of chronic pancreatitis or idiopathic acute pancreatitis, or with obvious signs and symptoms of pancreatitis at the time of screening, or who have undergone pancreatectomy;

18. Treatment with systemic glucocorticoids (other than inhaled or topical glucocorticoids) within 4 weeks before screening;

19. Laboratory values at screening or before randomization:

1. fasting blood glucose =13.9mmol/l;

2. ALT and/or AST > 3× upper limit of normal (ULN);

3. serum calcitonin =ULN;

4. estimated glomerular filtration rate (eGFR) <45 ml/min/1.73m^2 (estimated using CKD-EPI formula);

5. hemoglobin (Hgb) <100 g/L;

6. fasting triglyceride (TG) =5.7mmol/L;

7. serum amylase and/or lipase > 3×ULN (if lipase cannot be detected in some centers, it is acceptable to judge based on amylase only);

20. Prolonged QTc interval (QTc interval >450 msec in men and >460 msec in women) on 12-lead electrocardiogram at screening or before randomization; PR interval >220 ms; (QTc values need to be corrected by QTcF formula);

21. Serologic examination:

1. human immunodeficiency virus antibody or treponema pallidum antibody positive;

2. hepatitis C antibody positive;

3. hepatitis B surface antigen (ABsAg) is positive, and the quantitative test result of hepatitis B virus DNA is higher than the lower limit of the reference range;

22. Patients with a history of drug abuse, drug use, or alcohol dependence;

23. History of malignant tumor;

24. Women who are pregnant, lactating or have a positive pregnancy test;

25. Patients who participated in other clinical trials within 3 months before screening and received the last study medication within 3 months;

26. Patients who had other factors, as judged by the investigator, that precluded participation in the trial.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• semaglutide injection (HD1916)
Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks Other Name: HD1916
• Ozempic®
Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks Other Name: Ozempic Injectable Product

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangdong	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to week 32 in glycosylated haemoglobin (HbA1c)		Week 32
Secondary	Change from baseline to week 20 in HbA1c		Week 20
Secondary	Change from baseline to week 20, 32 in fasting blood glucose		Week 20 and 32
Secondary	Percentage of participants who achieved HbA1c < 7.0% and HbA1c =6.5% at week 20 or week 32		Week 20 and 32
Secondary	Change from baseline to week 20, 32 in body weight		Week 20 and 32
Secondary	Change from baseline to week 20, 32 in postprandial blood glucose		Week 20 and 32
Secondary	Percentage of participants who were offered rescue medication at week 20		Week 32
Secondary	Incidence and severity of adverse events		Week 35
Secondary	Occurence of anti-semaglutide antibodies and neutralizing antibody		Week 35
Secondary	Blood concentration of semaglutide		Week 35