Clinical trial NCT05816057: A Study of the Efficacy and Safety of Semaglutide Injection in the Treatment of Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Sponsor class: INDUSTRY
First posted: 2023-04-18
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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:

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.

Primary outcomes:
measure: The observed mean change in Glycosylated Haemoglobin A1c (HbA1c) values from baseline after 32 weeks of treatment.
timeFrame: 32 weeks
Secondary outcomes:
measure: The observed mean change in HbA1c values from baseline after 20 weeks of treatment.
timeFrame: 20 weeks
measure: Change From Baseline to Week 20 in Fasting Plasma Glucose (FPG).
timeFrame: 20 weeks
measure: Change From Baseline to Week 32 in Fasting Plasma Glucose (FPG).
timeFrame: 32 weeks
measure: Change From Baseline to Week 32 in HbA1c < 7.0% of participants.
timeFrame: 32 weeks
measure: Change From Baseline to Week 32 in HbA1c≤6.5% of participants.
timeFrame: 32 weeks
measure: Change From Baseline to Week 32 in HbA1c < 7.0% of participants with no hypoglycemic events.
timeFrame: 32 weeks
measure: Change From Baseline to Week 32 in Body Weight (Kilogram (kg)).
timeFrame: 32 weeks
measure: Change From Baseline to Week 32 in Systolic and Diastolic Blood Pressure.
timeFrame: 32 weeks
measure: Change From Baseline to Week 32 in Pulse Rate.
timeFrame: 32 weeks
measure: 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).
timeFrame: 32weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
state: Anhui
city: Guangzhou
country: China
facility: NanFang Hospital
state: Guangdong
city: Cangzhou
country: China
facility: CANGZHOU People's Hospital
state: Hebei
city: Cangzhou
country: China
facility: CANGZHOU Central Hospital
state: Hebei
city: Cangzhou
country: China
facility: Cang zhou Hospital of Integrated Traditional Chinese and Western of Hebei Province
state: Hebei
city: Shijiazhuang
country: China
facility: Shijiazhuang Second Hospital
state: Hebei
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Nanyang
country: China
facility: Nanyang First People's Hospital
state: Henan
city: Nanyang
country: China
facility: Nanyang Second General Hospital
state: Henan
city: Nanyang
country: China
facility: The First Affiliated Hospital of Nanyang Medical College
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Huangshi
country: China
facility: Huangshi Central Hospital
state: Hubei
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Guangdong
country: China
facility: Huizhou Central People's Hospital
state: Huizhou
city: Yueyang
country: China
facility: Yueyang People's Hospital
state: Hunan
city: Baotou
country: China
facility: BaogangHospital of InnerMongolia
state: Inner Mongolia
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Huaian
country: China
facility: Huai'an Second People's Hospital
state: Jiangsu
city: Huaian
country: China
facility: The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
state: Jiangsu
city: Lianyungang
country: China
facility: The Second People's Hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital OF Soochow University
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Cancer Hospital
state: Jiangsu
city: Zhengjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
state: Jiangxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an jiaotong university
state: Shaanxi
city: Jinan
country: China
facility: Central Hospital Affiliated to Shandong First Medical University
state: Shandong
city: Shanghai
country: China
facility: Huadong Hospital Affillated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong New Area People's Hospital
state: Shanghai
city: Jincheng
country: China
facility: Jincheng Grand Hospital
state: Shanxi
city: Yuncheng
country: China
facility: Shanxi Yuncheng Central Hospital
state: Shanxi
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: xiaoying Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: