AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3NCT05816057

A Study of the Efficacy and Safety of Semaglutide Injection in the Treatment of Type 2 Diabetes Mellitus

A Phase 3 study testing semaglutide injection in people with Diabetes Mellitus, Type 2, run by Hangzhou Jiuyuan Gene Engineering Co. Ltd., at 35 sites in China.

Completed

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

Official record
Search all trials

Trial summary

Semaglutide injection is a new drug developed according to Ozempic® biosimilars.This trial is conducted in China. The purpose of this study is to investigate the similarities in the efficacy and safety of semaglutide injection and Ozempic® in the treatment of type 2 diabetes, respectively. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
semaglutide injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
476 participants
Where
35 sitesChina
Study dates
25 Jul 2022to 31 Oct 2023
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

  • Volunteer to participate in the trial and sign the informed consent form；
  • Diagnosed with type 2 diabetes And Stable daily dose for 4 weeks prior to the day of screening of the metformin formulations (greater than or equal to 1500 mg to less than or equal to 2000 mg or maximum tolerated dose documented greater than or equal to 1000 mg)；
  • Male or female, Aged 18-75 years (both inclusive) at the time of signing informed consent；
  • Glycated haemoglobin (HbA1c) of greater than 7.0% to less than or less than or equal to 11.0%.

Who cannot join

  • Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within the past 4 weeks prior to the day of screening. However, short-term insulin treatment for a maximum of 7 days prior to the day of screening is allowed;
  • Systemic corticosteroids (excluding topical and inhaled preparations) within the past 90 days to the day of screening;
  • Known or suspected hypersensitivity to trial product(s) or related products;
  • Have participated in other clinical trials and used investigational drugs within the past 90 days to the day of screening;
  • Heart failure(Subjects presently classified as being in New York Heart Association Class IV); Acute coronary syndrome or cerebrovascular events, including but not limited to acute myocardial infarction, stroke, unstable angina or transient ischaemic attack; Have undergone heart-related surgery; or investigator assessment of severe ECG abnormalities, poorly controlled hypertension (defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), and other cardiovascular and cerebrovascular disorders that are not suitable within the past 90 days prior to the day of screening;
  • Known to plan to be hospitalized for any surgery at the time of screening;
Show all 15Show fewer
  • Hyperthyroidism, Cushing's syndrome, Diabetic gastroparesis or other gastrointestinal disorders; Gastrointestinal disorders assessed by investigators as increasing post-medication risk, anorexia, alcohol dependence, drug use, drug dependence, epilepsy, psychiatric illness, need for systemic anti-infective therapy, or other conditions assessed by investigators as affecting endpoint assessment;
  • Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC);
  • History or presence of pancreatitis (acute or chronic);
  • Proliferative diabetic retinopathy.
  • Recurrent severe hypoglycaemia (more than 3 severe hypoglycaemic events) within the past 90 days to the day of screening;
  • Acute metabolic complications within the past 180 days prior to the day of screening;
  • Subjects with calcitonin ≥ 50 ng/L pg/mL) ,AMY ≥3×upper normal limit (UNL), triglyceride ≥5.7 mmol/L( 500 mg/dL) ,eGFR<60 mL/min/1.73 m2,; hemoglobin ≤120 g/L (male) or ≤110 g/L (female), ALT、AST≥ 2.5 ×UNL,TBIL≥2×ULN;
  • History or presence of malignant neoplasms within the last 5 years (except basal or squamous cell skin cancer and carcinoma in situ);
  • The female who is pregnant, breast-feeding or Female/male intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive method; （16））Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

China35 sites

  • BaogangHospital of InnerMongolia

    Baotou, Inner Mongolia, 014000

  • CANGZHOU People's Hospital

    Cangzhou, Hebei, 61000

  • CANGZHOU Central Hospital

    Cangzhou, Hebei, 61001

  • Cang zhou Hospital of Integrated Traditional Chinese and Western of Hebei Province

    Cangzhou, Hebei, 61013

  • Changzhou No.2 People's Hospital

    Changzhou, Jiangsu, 213003

  • Huizhou Central People's Hospital

    Guangdong, Huizhou, 516003

  • NanFang Hospital

    Guangzhou, Guangdong, 510000

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010000

  • Huai'an Second People's Hospital

    Huaian, Jiangsu, 223000

  • The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University

    Huaian, Jiangsu, 223000

  • Huangshi Central Hospital

    Huangshi, Hubei, 435000

  • Central Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250000

  • Jincheng Grand Hospital

    Jincheng, Shanxi, 048006

  • The Second People's Hospital of Lianyungang

    Lianyungang, Jiangsu, 222006

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 450052

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

  • Nanyang First People's Hospital

    Nanyang, Henan, 473000

  • Nanyang Second General Hospital

    Nanyang, Henan, 473000

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, Henan, 473000

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, 0799-6881723

  • Huadong Hospital Affillated to Fudan University

    Shanghai, Shanghai Municipality, 200030

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200030

  • Shanghai Pudong New Area People's Hospital

    Shanghai, Shanghai Municipality, 201299

  • Shijiazhuang Second Hospital

    Shijiazhuang, Hebei, 050000

  • The First Affiliated Hospital OF Soochow University

    Suzhou, Jiangsu, 215006

  • The First Affiliated Hospital of Xi'an jiaotong university

    Xi'an, Shaanxi, 710000

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • Xuzhou Cancer Hospital

    Xuzhou, Jiangsu, 221000

  • Yichang Central People's Hospital

    Yichang, Hubei, 443003

  • Yueyang People's Hospital

    Yueyang, Hunan, 414000

  • Shanxi Yuncheng Central Hospital

    Yuncheng, Shanxi, 044099

  • Affiliated Hospital of Jiangsu University

    Zhengjiang, Jiangsu, 212001

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450014

Other trials in China

About this study

Official title: A Multicenter, Randomized, Open-label, and Parallel Assignment Phase III Study to Compare the Efficacy and Safety of Semaglutide Injection With Ozempic® in Combination With Metformin in the Treatment of Type 2 Diabetes

Semaglutide injection is a new drug developed according to Ozempic® biosimilars.This trial is conducted in China. The purpose of this study is to investigate the similarities in the efficacy and safety of semaglutide injection and Ozempic® in the treatment of type 2 diabetes, respectively.

Read the detailed description

This study is a multicenter, randomized, open-label, parallel assignment, which plans to enroll 476 patients with type 2 diabetes And Stable daily dose for 4 weeks prior to the day of screening of the metformin formulations (greater than or equal to 1500 mg to less than or equal to 2000 mg or maximum tolerated dose documented greater than or equal to 1000 mg. The study was divided into three phases: screening, baseline and treatment.

Being tested
semaglutide injection
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 injectionBiological

    The subject will receive either a dose semaglutide once weekly (subcutaneous (s.c.) injection). The initial dose of 0.25 mg is s.c. once weekly, and the dose is increased to 0.5 mg after 4 weeks of administration, and the dose is increased to 1 mg after 4 weeks of 0.5 mg administration, and the dose is continued at a stable dose of 1 mg for 24 weeks.Treatment duration 32 weeks.

Study groups in NCT05816057
Study groupRoleWhat they receive
semaglutide injectionExperimentalSemaglutide 0.25 mg、0.5 mg、1.0mg
Receives: Biological: semaglutide injection
ozempic®Active comparatorOzempic® 0.25 mg、0.5 mg、1.0mg
Receives: Biological: semaglutide injection

What is being measured

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

  1. The observed mean change in Glycosylated Haemoglobin A1c (HbA1c) values from baseline after 32 weeks of treatment.

    Measured: 32 weeks

Secondary outcomes (10)

  1. The observed mean change in HbA1c values from baseline after 20 weeks of treatment.

    Measured: 20 weeks

  2. Change From Baseline to Week 20 in Fasting Plasma Glucose (FPG).

    Measured: 20 weeks

  3. Change From Baseline to Week 32 in Fasting Plasma Glucose (FPG).

    Measured: 32 weeks

  4. Change From Baseline to Week 32 in HbA1c < 7.0% of participants.

    Measured: 32 weeks

  5. Change From Baseline to Week 32 in HbA1c≤6.5% of participants.

    Measured: 32 weeks

  6. Change From Baseline to Week 32 in HbA1c < 7.0% of participants with no hypoglycemic events.

    Measured: 32 weeks

  7. Change From Baseline to Week 32 in Body Weight (Kilogram (kg)).

    Measured: 32 weeks

  8. Change From Baseline to Week 32 in Systolic and Diastolic Blood Pressure.

    Measured: 32 weeks

  9. Change From Baseline to Week 32 in Pulse Rate.

    Measured: 32 weeks

  10. Change From Baseline to Week 32 in Fasting Blood Lipids: Total Cholesterol、Low-density Lipoprotein (LDL) Cholesterol、 High-density Lipoprotein (HDL) Cholesterol 、Triglycerides (Ratio to Baseline).

    Measured: 32weeks

Timeline

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

  1. First posted18 Apr 2023
  2. Study start25 Jul 2022
  3. Primary completion25 Jul 2023
  4. Study completion31 Oct 2023

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
476 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05816057
Sponsor's protocol ID
JY-2021-05
Status last verified
Jan 2024
First submitted
20 Feb 2023
Last updated
3 Jan 2024
Results posted
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 in people with Diabetes Mellitus, Type 2, run by Hangzhou Jiuyuan Gene Engineering Co. Ltd., at 35 sites 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 4 inclusion and 15 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites 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?

The observed mean change in Glycosylated Haemoglobin A1c (HbA1c) values from baseline after 32 weeks of treatment. (time frame: 32 weeks). 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 NCT05816057.

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 3 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in