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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05816057
• Other study ID #: JY-2021-05
• Status: Completed
• Phase: Phase 3
• Start date: July 25, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: January 2024
• Source: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 476
• Est. completion date: October 31, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
China	BaogangHospital of InnerMongolia	Baotou	Inner Mongolia
China	Cang zhou Hospital of Integrated Traditional Chinese and Western of Hebei Province	Cangzhou	Hebei
China	CANGZHOU Central Hospital	Cangzhou	Hebei
China	CANGZHOU People's Hospital	Cangzhou	Hebei
China	Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	Huizhou Central People's Hospital	Guangdong	Huizhou
China	NanFang Hospital	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia
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	Huangshi Central Hospital	Huangshi	Hubei
China	Central Hospital Affiliated to Shandong First Medical University	Jinan	Shandong
China	Jincheng Grand Hospital	Jincheng	Shanxi
China	The Second People's Hospital of Lianyungang	Lianyungang	Jiangsu
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
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	Pingxiang People's Hospital	Pingxiang	Jiangxi
China	Huadong Hospital Affillated to Fudan University	Shanghai	Shanghai
China	Shanghai Pudong New Area People's Hospital	Shanghai	Shanghai
China	Zhongshan Hospital	Shanghai	Shanghai
China	Shijiazhuang Second Hospital	Shijiazhuang	Hebei
China	The First Affiliated Hospital OF Soochow University	Suzhou	Jiangsu
China	The First Affiliated Hospital of Xi'an jiaotong university	Xi'an	Shaanxi
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Xuzhou Cancer Hospital	Xuzhou	Jiangsu
China	Yichang Central People's Hospital	Yichang	Hubei
China	Yueyang People's Hospital	Yueyang	Hunan
China	Shanxi Yuncheng Central Hospital	Yuncheng	Shanxi
China	Affiliated Hospital of Jiangsu University	Zhengjiang	Jiangsu
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The observed mean change in Glycosylated Haemoglobin A1c (HbA1c) values from baseline after 32 weeks of treatment.		32 weeks
Secondary	The observed mean change in HbA1c values from baseline after 20 weeks of treatment.		20 weeks
Secondary	Change From Baseline to Week 20 in Fasting Plasma Glucose (FPG).		20 weeks
Secondary	Change From Baseline to Week 32 in Fasting Plasma Glucose (FPG).		32 weeks
Secondary	Change From Baseline to Week 32 in HbA1c < 7.0% of participants.		32 weeks
Secondary	Change From Baseline to Week 32 in HbA1c=6.5% of participants.		32 weeks
Secondary	Change From Baseline to Week 32 in HbA1c < 7.0% of participants with no hypoglycemic events.		32 weeks
Secondary	Change From Baseline to Week 32 in Body Weight (Kilogram (kg)).		32 weeks
Secondary	Change From Baseline to Week 32 in Systolic and Diastolic Blood Pressure.		32 weeks
Secondary	Change From Baseline to Week 32 in Pulse Rate.		32 weeks
Secondary	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).		32weeks