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

NCT06161844 | Completed Phase 3

• 1 other identifier: HD1916-002
• Study Type: interventional
• Target: 506
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change from baseline to week 32 in glycosylated haemoglobin (HbA1c)

  Week 32

Secondary Outcomes (9)

• Change from baseline to week 20 in HbA1c

  Week 20

• Change from baseline to week 20, 32 in fasting blood glucose

  Week 20 and 32

• Percentage of participants who achieved HbA1c < 7.0% and HbA1c ≤6.5% at week 20 or week 32

  Week 20 and 32

• Change from baseline to week 20, 32 in body weight

  Week 20 and 32

• Change from baseline to week 20, 32 in postprandial blood glucose

  Week 20 and 32

Study Arms (2)

Semaglutide injection (HD1916)

EXPERIMENTAL

Up to 1.0 mg semaglutide (HD1916) Metformin ≥ 1500 mg/day

Drug: semaglutide injection (HD1916)

Ozempic®

ACTIVE COMPARATOR

Up to 1.0 mg semaglutide (Ozempic®) Metformin ≥ 1500 mg/day

Drug: Ozempic®

Interventions

semaglutide injection (HD1916) DRUG

Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks Other Name: HD1916

Semaglutide injection (HD1916)

Ozempic® DRUG

Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks Other Name: Ozempic Injectable Product

Ozempic®

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 years and ≤75 years old;
• Patients diagnosed with type 2 diabetes;
• 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), the treatment lasted for ≥8 weeks;
• At the time of screening, HbA1c ≥ 7.5% and ≤ 11.0% (local lab); At baseline, HbA1c ≥ 7.0% and ≤10.5% (central lab);
• At the time of screening, BMI≥18.5 kg/m\^2 and ≤35 kg/m\^2;
• 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;
• The patient is able to understand the informed consent form, voluntarily participate in the trial and sign the informed consent form.

You may not qualify if:

• Patients with type 1 diabetes or other special types of diabetes;
• 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;
• Patients who meet the contraindications of GLP-1 RA drugs and metformin hydrochloride drugs;
• Known allergy to the investigational drugs or excipients;
• Acute metabolic complications within 6 months before screening, including but not limited to: diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), or lactic acidosis;
• 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.);
• 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;
• 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;
• 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;
• 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;
• Have undergone metabolic surgery prior to screening, or had used medications and/or supplements with approved weight-loss indications within 3 months;
• Patients with severe heart disease or cardiac insufficiency. Including, but not limited to, decompensated heart failure (NYHA class Ш or Ⅳ); 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;
• Patients with incident cerebrovascular events (including, but not limited to, ischemic stroke, hemorrhagic stroke, and transient ischemic attack) within 6 months prior to screening;
• Uncontrolled hypertension (defined as systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg), or hypotension (blood pressure \< 90/60mmHg at screening);
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) at screening;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangdong, Guangdong, 510235, 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: November 30, 2023
• First Posted: December 8, 2023
• Study Start: February 23, 2024
• Primary Completion: May 14, 2025
• Study Completion: May 14, 2025
• Last Updated: July 11, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)