NCT06235086进行中（未招募）3 期
A Multicenter, Randomized, Open-label, Controlled Phase 3 Trial of TG103 Injection in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 632 人开始时间: 2024年4月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 632
- 试验地点
- 1
- 主要终点
- Changes in glycosylated hemoglobin (HbA1c) from baseline at 28 weeks of treatment
研究概览
简要总结
This is a randomized, open-label, dulaglutide-controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, and immunogenicity of different doses of TG103 injection in combination with metformin in subjects with type 2 diabetes with poor glycemic control treated with metformin monotherapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects have diagnosed with type 2 diabetes according to the Guidelines for prevention and treatment of type 2 diabetes in China (2020 Edition), T2DM was diagnosed at least 8 weeks before screening;
- •Aged 18 to 75 years (inclusive), no gender limitation;
- •Body Mass Index (BMI): 18.5≤BMI≤40;
- •Received stable dose of metformin hydrochloride monotherapy for ≥8 weeks before screening and metformin dose ≥1500 mg/ day ;
- •HbA1c must meet the following criteria:
- •Screening: 7.5% ≤ HbA1c ≤ 11.0% (Local laboratory)
- •Baseline: 7.0% ≤ HbA1c ≤ 10.5% (Central laboratory)
- •Subjects of childbearing potential must use reliable methods of contraception throughout the study period and at least 3 months after the last dose to avoid pregnancy in female subjects or pregnancy in the male subject's partner;
- •Willing and able to accurately use home glucose meter for self-glucose monitoring;
- •Be able to understand and follow the trial procedure, voluntarily participate in the trial and sign the informed consent form.
排除标准
- •Type 1 diabetes;
- •Body weight change more than 5% within 1 month prior to screening;
- •Received any of the following medications:
- •Prior discontinuation of DPP-4 inhibitors or GLP-1 receptor agonists for efficacy, tolerability, and safety reasons;
- •Systemic glucocorticoid and growth hormone,or other drugs affecting glucose metabolism have been used within 8 weeks before screening;
- •History of ≥2 episodes of grade 3 hypoglycemia within 6 months prior to screening, or grade 3 hypoglycemia between screening to randomization;
- •Acute complications of diabetes, such as diabetic ketoacidosis and hyperglycemic hyperosmolar status, occurred ≥1 time within 6 months prior to screening;
- •Severe chronic complications of diabetes (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within 6 months prior to screening
- •History of acute or chronic pancreatitis prior to screening;
- •Subjects with clinically significant gastric emptying abnormalities (e.g., gastric outlet obstruction), severe chronic gastrointestinal diseases (e.g., gastroparesis, inflammatory bowel disease, or intestinal obstruction) within 6 months prior to screening, or who have undergone gastrointestinal surgery that affects gastric emptying;
- •Any of the following cardiovascular events within 6 months prior to screening: decompensated cardiac insufficiency (NYHA class III or IV); history of unstable angina pectoris, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; or long QT syndrome or prolonged QTcF interval (QTcF: male >450 ms, female >470 ms) on 12-lead ECG; severe arrhythmias that are evaluated by the investigator to be inappropriate for participation in this clinical trial;
- •Hemorrhagic stroke or acute ischemic stroke disease occurred within 6 months prior to screening;
- •History of psychiatric diseases (such as depression, anxiety, etc.) during screening; or symptomatic gallbladder disease; or history of other diseases that may endanger the safety of the subject and that the investigator deems inappropriate for enrollment;
- •Any type of malignant tumor treated or untreated within 5 years prior to screening (except for clinically cured basal cell carcinoma or carcinoma in situ);
- •Severe infection within 4 weeks prior to screening, or refractory urinary tract or genital infection within 6 months prior to screening;
- •Having a significant blood system disease (e.g., aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or red blood cell instability (e.g., malaria) at screening;
- •Subjects with thyroid dysfunction that cannot be controlled by a stable drug dose at screening, or with clinically significant abnormalities in thyroid function examination results requiring drug treatment at screening;
- •Personal or family history of medullary thyroid cancer (MTC) or type 2 multiple endocrine tumor syndrome at screening;
- •Any of the indicators meet the following criteria:
- •i. Systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100mmHg at screening or before randomization;
- •ii. Laboratory tests show any of the following abnormalities:
- •FPG≥13.9 mmol/L;
- •ALT or AST≥2.5×ULN;
- •Total bilirubin (TBiL) ≥2.0×ULN;
- •Triglyceride >5.7 mmol/L;
- •eGFR<45 mL/(min*1.73 m^2);
- •Serum amylase and/or lipase ≥3×ULN;
- •Hemoglobin <100 g/L;
- •Calcitonin≥50 ng/L(pg/mL);
- •iii. Serological examination:
- •Human immunodeficiency virus antibody or treponema pallidum antibody is positive;
- •Hepatitis C antibody is positive, and HCV RNA was higher than the lower limit of the detection reference range;
- •Hepatitis B surface antigen is positive, and the quantitative detection result of HBV DNA was higher than the lower limit of the detection reference range;
- •Known allergy to the test drug, Dulaglutide, Empagliflozin, or related excipients;
- •Subjects who have lost more than 400 mL blood due to blood donation or other reasons within 3 months prior to screening;
- •Average alcohol intake more than 21 units of alcohol (male)/14 units of alcohol (female) per week within the 3 months prior to screening (1 unit ≈360 mL beer, or 45 mL spirits with 40% alcohol content, or 150 mL wine);
- •Subject participated in any drug or medical device clinical study within 3 months prior to screening (except for screening failure);
- •Pregnant or lactating female;
- •Not suitable for this study in the investigator's opinion.
研究组 & 干预措施
TG103, 15 mg
Experimental
TG103 (15 mg) will be administered via subcutaneous injection once a week in subjects with type 2 diabetes.
干预措施: TG103 (Drug)
TG103, 7.5 mg
Experimental
TG103 (7.5 mg) will be administered via subcutaneous injection once a week in subjects with type 2 diabetes.
干预措施: TG103 (Drug)
Dulaglutide
Experimental
Dulaglutide will be administered via subcutaneous injection once a week in subjects with type 2 diabetes.
干预措施: Dulaglutide (Drug)
结局指标
主要结局
Changes in glycosylated hemoglobin (HbA1c) from baseline at 28 weeks of treatment
时间窗: Baseline through Week28
次要结局
- Changes in HbA1c from baseline at 52 weeks of treatment(Baseline through Week52)
- Change in blood lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) from baseline at week 28 and 52.(Baseline through Week28 and 52)
- The percentage of HbA1c≤6.5% and the percentage of HbA1c≤7% at week 28 and 52(Week28 and 52)
- Mean 7 point blood glucose curve from baseline at week 28 and 52. Change in mean postprandial blood glucose increment from baseline at week 28 and 52.(Baseline through Week28 and 52)
- Incidence of adverse events(Week-2 through 52)
- Change in fasting plasma glucose (FPG) from baseline at week 28 and 52(Baseline through Week28 and 52)
- Proportion of subjects receiving remedial therapy at week 28 and 52(Week28 and 52)
- Change in weight from baseline at week 28 and 52(Baseline through Week28 and 52)
- The occurrence of TG103 anti-drug antibodies (ADA) and neutralizing antibody (NAb).(Week 0, 4, 8,16, 28, 36, 44, 52 and 55)
- Change in 2h-postprandial plasma glucose (2h-PPG) from baseline at week 28 and 52(Baseline through Week28 and 52)
- Blood concentrations of TG103(Week 0, 4, 8,16, 28, 36, 44, 52 and 55)
研究者
研究点 (1)
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