A Study of the Efficacy and Safety of Semaglutide Injection in the Treatment of Type 2 Diabetes Mellitus
NCT ID: NCT05816057
Last Updated: 2024-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
476 participants
INTERVENTIONAL
2022-07-25
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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semaglutide injection
Semaglutide 0.25 mg、0.5 mg、1.0mg
semaglutide 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.
ozempic®
Ozempic® 0.25 mg、0.5 mg、1.0mg
semaglutide 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.
Interventions
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semaglutide 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.
Eligibility Criteria
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Inclusion Criteria
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%.
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.
18 Years
75 Years
ALL
No
Sponsors
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Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
INDUSTRY
Responsible Party
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Principal Investigators
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xiaoying Li, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
NanFang Hospital
Guangzhou, Guangdong, China
CANGZHOU People's Hospital
Cangzhou, Hebei, China
CANGZHOU Central Hospital
Cangzhou, Hebei, China
Cang zhou Hospital of Integrated Traditional Chinese and Western of Hebei Province
Cangzhou, Hebei, China
Shijiazhuang Second Hospital
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Nanyang First People's Hospital
Nanyang, Henan, China
Nanyang Second General Hospital
Nanyang, Henan, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Huangshi Central Hospital
Huangshi, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
Huizhou Central People's Hospital
Guangdong, Huizhou, China
Yueyang People's Hospital
Yueyang, Hunan, China
BaogangHospital of InnerMongolia
Baotou, Inner Mongolia, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China
Huai'an Second People's Hospital
Huaian, Jiangsu, China
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
Huaian, Jiangsu, China
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital OF Soochow University
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Xuzhou Cancer Hospital
Xuzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhengjiang, Jiangsu, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
The First Affiliated Hospital of Xi'an jiaotong university
Xi'an, Shaanxi, China
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Huadong Hospital Affillated to Fudan University
Shanghai, Shanghai Municipality, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pudong New Area People's Hospital
Shanghai, Shanghai Municipality, China
Jincheng Grand Hospital
Jincheng, Shanxi, China
Shanxi Yuncheng Central Hospital
Yuncheng, Shanxi, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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JY-2021-05
Identifier Type: -
Identifier Source: org_study_id
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