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Type 2 Diabetes MellitusPhase 3NCT06161844

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

A Phase 3 study testing semaglutide injection (HD1916) and Ozempic® in people with Type 2 Diabetes Mellitus, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
semaglutide injection (HD1916) and Ozempic®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
506 participants
Where
1 siteChina
Study dates
23 Feb 2024to 14 May 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.);
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  • 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;
  • 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;
  • 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;
  • Treatment with systemic glucocorticoids (other than inhaled or topical glucocorticoids) within 4 weeks before screening;
  • Laboratory values at screening or before randomization:
  • fasting blood glucose ≥13.9mmol/l;
  • ALT and/or AST > 3× upper limit of normal (ULN);
  • serum calcitonin >ULN;
  • estimated glomerular filtration rate (eGFR) <45 ml/min/1.73m^2 (estimated using CKD-EPI formula);
  • hemoglobin (Hgb) <100 g/L;
  • fasting triglyceride (TG) ≥5.7mmol/L;
  • serum amylase and/or lipase > 3×ULN (if lipase cannot be detected in some centers, it is acceptable to judge based on amylase only);
  • 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);
  • Serologic examination:
  • human immunodeficiency virus antibody or treponema pallidum antibody positive;
  • hepatitis C antibody positive;
  • hepatitis B surface antigen (HBsAg) is positive, and the quantitative test result of hepatitis B virus DNA is higher than the upper limit of the reference range;
  • Patients with a history of drug abuse, drug use, or alcohol dependence;
  • History of malignant tumor;
  • Women who are pregnant, lactating or have a positive pregnancy test;
  • Patients who participated in other clinical trials within 3 months before screening and received the last study medication within 3 months;
  • Patients who had other factors, as judged by the investigator, that precluded participation in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Guangdong, Guangdong, 510235

Other trials in China

About this study

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

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.

Being tested
semaglutide injection (HD1916), Ozempic®
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • semaglutide injection (HD1916)Drug

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

  • Ozempic®Drug

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

Study groups in NCT06161844
Study groupRoleWhat they receive
Semaglutide injection (HD1916)ExperimentalUp to 1.0 mg semaglutide (HD1916) Metformin ≥ 1500 mg/day
Receives: Drug: semaglutide injection (HD1916)
Ozempic®Active comparatorUp to 1.0 mg semaglutide (Ozempic®) Metformin ≥ 1500 mg/day
Receives: Drug: Ozempic®

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 32

Secondary outcomes (9)

  1. Change from baseline to week 20 in HbA1c

    Measured: Week 20

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

    Measured: Week 20 and 32

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

    Measured: Week 20 and 32

  4. Change from baseline to week 20, 32 in body weight

    Measured: Week 20 and 32

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

    Measured: Week 20 and 32

  6. Percentage of participants who were offered rescue medication at week 20

    Measured: Week 32

  7. Incidence and severity of adverse events

    Measured: Week 35

  8. Occurence of anti-semaglutide antibodies and neutralizing antibody

    Measured: Week 35

  9. Blood concentration of semaglutide

    Measured: Week 35

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2023
  2. Study start23 Feb 2024
  3. Primary completion14 May 2025
  4. Study completion14 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
506 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06161844
Sponsor's protocol ID
HD1916-002
Status last verified
Oct 2024
First submitted
30 Nov 2023
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing semaglutide injection (HD1916) and Ozempic® in people with Type 2 Diabetes Mellitus, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to week 32 in glycosylated haemoglobin (HbA1c) (time frame: Week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06161844.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.

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