Efficacy and Safety of Semaglutide Injection Versus Ozempic® in Chinese Patients with Type 2 Diabetes: A Multi-center, Randomized, Open-label, Parallel-group, Phase 3 Study
Phase 3
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- ChiCTR2400088755
- Lead Sponsor
- Peking University People's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Voluntarily sign the informed consent;<br>2. Males and females who signed the informed consent are 18 to 75 years old (both inclusive);<br>3. Diagnosed with type 2 diabetes according to the WHO diagnosis criteria;<br>4. At screening, study center laboratory test of HbA1c =7.5% and =10.5%;<br>5. Subjects receive metformin treatment at a stable dose (=1500 mg/day or the maximum tolerated dose with =1000 mg/day, but <1500 mg/day) for at least 8 weeks;<br>6. At screening, body mass index (BMI) > 18.5 kg/m2 and =35 kg/m2;<br>7. Patients who are willing and able to receive treatment and follow-up visits as required in the protocol, and able to use glucometer for self-monitoring of blood glucose.
Exclusion Criteria
- Type 1 diabetes, specific types of diabetes;<br>2. Subjects have received any drug or treatment below:<br> (1) Have received other anti-diabetic drugs except metformin (including Chinese traditional medicine) within 8 weeks before the randomization;<br> (2) Have used non-diabetic drugs that may have a significant impact on glucose metabolism within 3 months before screening/randomization for 1 week or more, such as glucocorticoids, sympathetic stimulants, growth hormone, high-dose salicylic acids, danazol, octreotide and anabolic male steroids, hydrochlorothiazide or compound preparations containing hydrochlorothiazide components with the content of hydrochlorothiazide >25mg/ day;<br> (3) Have weight-loss related medical treatments and/or surgeries within 3 months before screening;<br>3. Subjects with any of the following history or condition below:<br> (1) A history of =2 episodes of severe hypoglycemia within 1 year before screening/randomization;<br> (2) Diabetic ketoacidosis or hyperglycemic hyperosmolar status occurring within 6 months before screening;<br> (3) With severe complications of T2DM at screening, such as proliferative diabetic retinopathy and macular edema; history of kidney transplantation; severe peripheral vascular disease (such as amputation, chronic foot ulcer, intermittent claudication);<br> (4) With untreated or inadequately controlled hypertension (defined as systolic blood pressure =160 mmhg and/or diastolic blood pressure =100 mmhg) at screening/randomization;<br> (5) With cardiovascular diseases such as acute coronary syndrome (including but not limited to acute myocardial infarction, or unstable angina pectoris), arrhythmia requiring treatment, severe heart failure (NYHA functional classification III or IV), history of coronary artery bypass grafting or coronary stent implantation within 6 months before screening;<br> (6) With new cerebrovascular accident (including ischemic stroke, hemorrhagic stroke and transient ischemic attack) within 6 months before screening;<br> (7) With severe trauma or severe infection requiring intravenous antimicrobial treatment within 1 month before screening;<br> (8) A history of acute or chronic pancreatitis;<br> (9) A history of cholecystitis due to cholelithiasis or other reasons within 6 months before screening;<br> (10) Combined with Cushing's syndrome, hyperthyroidism and inadequately controlled hypothyroidism at screening;<br> (11) With significant abnormalities of gastric emptying (such as gastric outlet obstruction) and serious gastrointestinal diseases during screening;<br> (12) Any disease that may cause hemolysis or erythrocyte instability and affect HbA1c detection, such as hematological system tumors, hemolytic anemia, sickle cell disease;<br> (13) Medullary thyroid cancer (MTC) or multiple endocrine neoplasia type 2 (men2) disease history or family history;<br> (14) A history of malignant tumor in the past 5 years or currently evaluating potential malignant tumors, excluding clinically cured cervical carcinoma in situ and skin basal cell carcinoma;<br> (15) Known to be hospitalized for surgical treatment;<br>4. Any laboratory test result during screening/randomization meets the following criteria:<br> (1) Impaired liver function: ALT or AST =2.5 times the upper limit of normal value, or total bilirubin = 2 times the upper limit of normal value;<br> (2) Impaired renal function: glomerular filtration rate (EGFR, CKD-EPI formula) < 60ml/min/1.73m2 (see Appendix 5 for calculation formula);<br> (3) Calcitonin =50ng/
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change from baseline in HbA1c at week 32;
- Secondary Outcome Measures
Name Time Method The change from baseline in HbA1c at week 20;The proportion of subjects achieves HbA1c =6.5% at week 32;The proportion of subjects achieves HbA1c <7.0% at week 32;Changes from baseline in fasting plasma glucoseat week 20 and week 32;The change from baseline in body weight at week 32;Changes from baseline in blood pressure (diastolic blood pressure and systolic blood pressure) at week 32;Changes from baseline in blood lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) at week 32;