NCT07046273尚未招募3 期
A Multicenter, Randomized, Open, Parallel-controlled, Phase III Clinical Study on the Efficacy and Safety of Semaglutide and Ozempic® in Patients With Type 2 Diabetes
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 496
- 主要终点
- Change in HbA1c from baseline
研究概览
简要总结
This study is a multicenter, randomized, open, parallel-controlled, Phase III clinical study aimed to evaluate the efficacy and safety of semaglutide injection and Ozempic® in patients with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary signing of informed consent; 2) Aged 18-75 years (inclusive) at the time of signing the informed consent, male or female; 3) Diagnosed with type 2 diabetes according to the WHO diabetes diagnostic criteria; 4) Laboratory tests at the research center at screening: 7.5%≤HbA1c≤10.5%; 5) Before randomization, study participants received stable doses of metformin (≥1500mg/day or maximum tolerated dose: <1500mg/day, but ≥1000mg/day) for at least 8 weeks (maximum tolerated dose must be supported by previous medical records); 6) Body mass index (BMI) ≥18.5kg/m2 and ≤35.0kg/m2 at screening; 7) Willing and able to undergo treatment and follow-up as required by the protocol.
排除标准
- •Type 1 diabetes, special type of diabetes;
- •Received hypoglycemic drugs other than metformin (including Chinese medicine) within 8 weeks before randomization;
- •Used non-diabetes treatment drugs that may have a significant impact on glucose metabolism for 1 week or more within 3 months before randomization, such as glucocorticoids (systemic glucocorticoids used for <7 days, excluding inhalation, ocular medication or topical application), sympathetic nerve stimulants (such as isoproterenol, dopamine, atropine, etc.), growth hormone, high-dose salicylates (300 mg/day and above), danazol, octreotide and anabolic androgenic steroids (such as oxymetholone, oxandrolone, etc.);
- •Has a history of ≥2 episodes of grade 3 hypoglycemia within 1 year before randomization;
- •Diabetic ketoacidosis or hyperglycemic hyperosmolar state within 3 months before randomization;
- •Severe complications of diabetes at screening: such as proliferative diabetic retinopathy, macular edema; history of renal transplantation; severe peripheral vascular disease (such as amputation, chronic foot ulcers, intermittent claudication);
- •Untreated or poorly controlled hypertension (defined as systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg) at screening/randomization;
- •Cardiovascular diseases such as acute coronary syndrome (including but not limited to acute myocardial infarction, or unstable angina), arrhythmia requiring treatment, severe heart failure (refer to New York Heart Association heart function grade III or IV), coronary artery bypass grafting or coronary stent implantation within 6 months before screening;
- •New cerebrovascular accident (including ischemic stroke, hemorrhagic stroke and transient ischemic attack, etc.) within 6 months before screening;
- •Severe trauma or severe infection or surgery that may affect blood sugar control within 1 month before screening;
- •History of acute or chronic pancreatitis;
- •History of cholecystitis due to cholelithiasis or other reasons within 6 months before screening;
- •Cushing's syndrome, hyperthyroidism, and uncontrolled hypothyroidism at screening;
- •Significant gastric emptying abnormalities (such as gastric outlet obstruction) and severe gastrointestinal diseases at screening;
- •Any disease that may cause hemolysis or red blood cell instability and affect HbA1c detection, such as blood system tumors, hemolytic anemia, sickle cell disease;
- •History or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);
- •History of malignant tumors in the past 5 years (regardless of organ system, whether treated or not, and whether there is evidence of recurrence or metastasis) or currently being evaluated for potential malignant tumors, but excluding clinically cured cervical carcinoma in situ and skin basal cell carcinoma;
- •Meet any of the following criteria at screening:
- •Liver function impairment: ALT or AST ≥ 5 times the upper limit of normal, or total bilirubin ≥ 2 times the upper limit of normal; Renal function impairment: glomerular filtration rate (eGFR, CKD-EPI formula) < 45mL/min/1.73m2; Fasting triglyceride (TG) ≥ 5.7mmol/L after stable medication; Calcitonin ≥ 50ng/L; Hemoglobin ≤ 100g/L; Thyrotropin (TSH) > 6mIU/L after stable medication; Blood amylase or lipase ≥ 3 times the upper limit of normal; Hepatitis C virus antibody, human immunodeficiency virus antibody, syphilis serological test results are positive, hepatitis B virus surface antigen is positive and HBV-DNA is positive.
- •Known allergy to any component of semaglutide injection or allergy to other GLP-1 RA drugs;
- •Donated blood or lost ≥400mL of blood within 3 months before screening, or received blood transfusion therapy, or planned to donate blood during the trial;
- •Received other clinical research drugs or device treatments within 3 months before screening, or participated in other drug clinical trials and are still within 5 half-lives of the trial drug, whichever is older; or planned to participate in other clinical studies during the trial;
- •Have a history of drug abuse (including drug abuse) and/or alcohol dependence within 6 months before screening;
- •Mental disorder or language barrier, unable to fully understand and cooperate;
- •Pregnant or lactating women;
- •Male and female research participants who have fertility plans during the trial and within 2 months after the last dose of the trial drug, or are unwilling to take reliable contraceptive measures for contraception;
- •Other situations that the researcher considers unsuitable for participation in this study. -
研究组 & 干预措施
F027
Experimental
The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks.
干预措施: F027 (Drug)
Ozempic®
Active Comparator
The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks.
干预措施: Ozempic® (Drug)
结局指标
主要结局
Change in HbA1c from baseline
时间窗: Week 32
次要结局
- Percentage of Participants Who Achieved HbA1c <6.5%(Week 32)
- Change in Body Weight(Week 32)
- Semaglutide steady-state trough concentration (Css, min)(Week 32)
- Change in HbA1c from baseline(Week 20)
- Change in Fasting Glucose(Week 20 ,32)
- Incidence of hypoglycemic events and acute pancreatitis(Week 32)
- Percentage of participants who achieved HbA1c < 7.0%(Week 32)
- Collect the incidence of adverse events (AEs)/serious adverse events (SAEs) through vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, etc.(Week 32)
- Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (Nab)(Week 32)
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