A Study of the Efficacy and Safety of Semaglutide Injection in the Treatment of Type 2 Diabetes Mellitus
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
1 other identifier
interventional
476
1 country
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes-mellitus-type-2
Started Jul 2022
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 25, 2022
CompletedFirst Submitted
Initial submission to the registry
February 20, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedJanuary 3, 2024
January 1, 2024
1 year
February 20, 2023
January 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The observed mean change in Glycosylated Haemoglobin A1c (HbA1c) values from baseline after 32 weeks of treatment.
32 weeks
Secondary Outcomes (10)
The observed mean change in HbA1c values from baseline after 20 weeks of treatment.
20 weeks
Change From Baseline to Week 20 in Fasting Plasma Glucose (FPG).
20 weeks
Change From Baseline to Week 32 in Fasting Plasma Glucose (FPG).
32 weeks
Change From Baseline to Week 32 in HbA1c < 7.0% of participants.
32 weeks
Change From Baseline to Week 32 in HbA1c≤6.5% of participants.
32 weeks
- +5 more secondary outcomes
Study Arms (2)
semaglutide injection
EXPERIMENTALSemaglutide 0.25 mg、0.5 mg、1.0mg
ozempic®
ACTIVE COMPARATOROzempic® 0.25 mg、0.5 mg、1.0mg
Interventions
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
You may qualify if:
- 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%.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
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 Municipality, 200030, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200030, China
Shanghai Pudong New Area People's Hospital
Shanghai, Shanghai Municipality, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
xiaoying Li, M.D.
Shanghai Zhongshan Hospital
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
February 20, 2023
First Posted
April 18, 2023
Study Start
July 25, 2022
Primary Completion
July 25, 2023
Study Completion
October 31, 2023
Last Updated
January 3, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share