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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| semaglutide injection | Experimental | Semaglutide 0.25 mg、0.5 mg、1.0mg |
|
| ozempic® | Active Comparator | Ozempic® 0.25 mg、0.5 mg、1.0mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide injection | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The observed mean change in Glycosylated Haemoglobin A1c (HbA1c) values from baseline after 32 weeks of treatment. | 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| xiaoying Li, M.D. | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China | ||
| NanFang Hospital |
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|
| 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 |
| Change From Baseline to Week 32 in HbA1c < 7.0% of participants with no hypoglycemic events. | 32 weeks |
| Change From Baseline to Week 32 in Body Weight (Kilogram (kg)). | 32 weeks |
| Change From Baseline to Week 32 in Systolic and Diastolic Blood Pressure. | 32 weeks |
| Change From Baseline to Week 32 in Pulse Rate. | 32 weeks |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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