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CompletedNCT05816057Updated Jan 3, 2024

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

A Phase 3 interventional study of semaglutide injection in Diabetes Mellitus, Type 2, sponsored by Hangzhou Jiuyuan Gene Engineering Co. Ltd.,. Completed at 35 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-03.

Sponsored by Hangzhou Jiuyuan Gene Engineering Co. Ltd., · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jul 2022, registered Feb 2023).
Phase
Phase 3
Study type
Interventional
Enrollment
476
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 476 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Hangzhou Jiuyuan Gene Engineering Co. Ltd., is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Volunteer to participate in the trial and sign the informed consent form;
  2. 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);
  3. Male or female, Aged 18-75 years (both inclusive) at the time of signing informed consent;
  4. Glycated haemoglobin (HbA1c) of greater than 7.0% to less than or less than or equal to 11.0%.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. Systemic corticosteroids (excluding topical and inhaled preparations) within the past 90 days to the day of screening;
  3. Known or suspected hypersensitivity to trial product(s) or related products;
  4. Have participated in other clinical trials and used investigational drugs within the past 90 days to the day of screening;
  5. 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;
  6. Known to plan to be hospitalized for any surgery at the time of screening;
  7. 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;
  8. Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC);
  9. History or presence of pancreatitis (acute or chronic);
  10. Proliferative diabetic retinopathy.
  11. Recurrent severe hypoglycaemia (more than 3 severe hypoglycaemic events) within the past 90 days to the day of screening;
  12. Acute metabolic complications within the past 180 days prior to the day of screening;
  13. 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;
  14. History or presence of malignant neoplasms within the last 5 years (except basal or squamous cell skin cancer and carcinoma in situ);
  15. 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
476 participants (actual)

Study arms

  • Experimental
    semaglutide injection

    Semaglutide 0.25 mg、0.5 mg、1.0mg

    Biological: semaglutide injection

  • Active comparator
    ozempic®

    Ozempic® 0.25 mg、0.5 mg、1.0mg

    Biological: semaglutide injection

Interventions

  • Biologicalsemaglutide injection

    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.

06

What researchers measure

Primary outcomes

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

    Time frame: 32 weeks

Secondary outcomes

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

    Time frame: 20 weeks

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

    Time frame: 20 weeks

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

    Time frame: 32 weeks

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

    Time frame: 32 weeks

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

    Time frame: 32 weeks

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

    Time frame: 32 weeks

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

    Time frame: 32 weeks

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

    Time frame: 32 weeks

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

    Time frame: 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).

    Time frame: 32weeks

07

Study locations

35 sites
  • The Second Affiliated Hospital of Anhui Medical University
    Hefei, Anhui 230601, China
  • NanFang Hospital
    Guangzhou, Guangdong 510000, China
  • CANGZHOU People's Hospital
    Cangzhou, Hebei 61000, China
  • CANGZHOU Central Hospital
    Cangzhou, Hebei 61001, China
  • Cang zhou Hospital of Integrated Traditional Chinese and Western of Hebei Province
    Cangzhou, Hebei 61013, China
  • Shijiazhuang Second Hospital
    Shijiazhuang, Hebei 050000, China
  • The First Affiliated Hospital of Henan University of Science and Technology
    Luoyang, Henan 450052, China
  • Nanyang First People's Hospital
    Nanyang, Henan 473000, China
  • Nanyang Second General Hospital
    Nanyang, Henan 473000, China
  • The First Affiliated Hospital of Nanyang Medical College
    Nanyang, Henan 473000, China
  • The Second Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan 450014, China
  • Huangshi Central Hospital
    Huangshi, Hubei 435000, China
  • Yichang Central People's Hospital
    Yichang, Hubei 443003, China
  • Huizhou Central People's Hospital
    Guangdong, Huizhou 516003, China
  • Yueyang People's Hospital
    Yueyang, Hunan 414000, China
  • BaogangHospital of InnerMongolia
    Baotou, Inner Mongolia 014000, China
  • The Affiliated Hospital of Inner Mongolia Medical University
    Hohhot, Inner Mongolia 010000, China
  • Changzhou No.2 People's Hospital
    Changzhou, Jiangsu 213003, China
  • Huai'an Second People's Hospital
    Huaian, Jiangsu 223000, China
  • The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
    Huaian, Jiangsu 223000, China
  • The Second People's Hospital of Lianyungang
    Lianyungang, Jiangsu 222006, China
  • The Second Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu 210011, China
  • The First Affiliated Hospital OF Soochow University
    Suzhou, Jiangsu 215006, China
  • The Affiliated Hospital of Xuzhou Medical University
    Xuzhou, Jiangsu 221000, China
  • Xuzhou Cancer Hospital
    Xuzhou, Jiangsu 221000, China
  • Affiliated Hospital of Jiangsu University
    Zhengjiang, Jiangsu 212001, China
  • Pingxiang People's Hospital
    Pingxiang, Jiangxi 0799-6881723, China
  • The First Affiliated Hospital of Xi'an jiaotong university
    Xi'an, Shaanxi 710000, China
  • Central Hospital Affiliated to Shandong First Medical University
    Jinan, Shandong 250000, China
  • Huadong Hospital Affillated to Fudan University
    Shanghai, Shanghai 200030, China
  • Zhongshan Hospital
    Shanghai, Shanghai 200030, China
  • Shanghai Pudong New Area People's Hospital
    Shanghai, Shanghai 201299, China
  • Jincheng Grand Hospital
    Jincheng, Shanxi 048006, China
  • Shanxi Yuncheng Central Hospital
    Yuncheng, Shanxi 044099, China
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310009, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05816057
Lead sponsor
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Responsible party
Sponsor
First posted
Apr 18, 2023
Start date
Jul 25, 2022
Primary completion
Jul 25, 2023
Completion
Oct 31, 2023
Last update
Jan 3, 2024

Study contacts

xiaoying Li, M.D.
principal investigator · Shanghai Zhongshan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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