phase 3 study of tg103 injection monotherapy in treatment of type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: this is a randomized, double-blind, placebo-parallel, multicenter phase 3 clinical trial to evaluate the efficacy of tg103 injection 7.5mg and 15mg once a week monotherapy compared with placebo in subjects with type 2 diabetes with poor glycemic control after diet and exercise.


Eligibility criteria:
inclusion criteria: * 1.subjects have diagnosed with type 2 diabetes according to the guidelines for prevention and treatment of type 2 diabetes in china (2020 edition), and have been diagnosed with t2dm for at least 8 weeks before screening; * 2.aged 18 to 75 years (inclusive), no gender limitation; * 3. body mass index (bmi): 18.5≤bmi≤40; * 4. no hypoglycemic drugs have been used within 8 weeks before screening, and the blood glucose control is poor after diet and exercise therapy alone * 5.the continuous use of insulin ≤14 days (except gestational diabetes), and/or the types of hypoglycemic drugs used in combination \<3 with the continuous use time ≤4 weeks within 1 year (more than 8 weeks) before screening; * 6.hba1c must meet the following criteria: * screening: 7.5% ≤ hba1c ≤ 11.0% (local laboratory) * baseline: 7.0% ≤ hba1c ≤ 10.5% (central laboratory) * 7.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; * 8. willing and able to accurately use home glucose meter for self-glucose monitoring; * 9. be able to understand and follow the trial procedure, voluntarily participate in the trial and sign the informed consent form. exclusion criteria: * 1. type 1 diabetes; * 2. body weight change more than 5% within 1 month prior to screening; * 3. received any of the following medications: 1. prior discontinuation of dpp-4 inhibitors or glp-1 receptor agonists for efficacy, tolerability, and safety reasons; 2. systemic glucocorticoid and growth hormone have been used within 8 weeks before screening; * 4. history of ≥2 episodes of grade 3 hypoglycemia within 6 months prior to screening, or grade 3 hypoglycemia between screening to randomization; * 5. acute complications of diabetes, such as diabetic ketoacidosis and hyperglycemic hyperosmolar status, occurred ≥1 time within 6 months prior to screening; * 6. severe chronic complications of diabetes (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within 6 months prior to screening * 7. history of acute or chronic pancreatitis prior to screening; * 8. 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; * 9. 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; 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; * 10. hemorrhagic stroke or acute ischemic stroke disease occurred within 6 months prior to screening; * 11. 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; * 12. 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); * 13. severe or acute infection within 4 weeks prior to screening, or refractory urinary tract or genital infection within 6 months prior to screening; * 14. 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; * 15. 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; * 16. personal or family history of medullary thyroid cancer (mtc) or type 2 multiple endocrine tumor syndrome at screening; * 17. 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: 1. fpg≥13.9 mmol/l; 2. alt or ast≥2.5×uln; 3. total bilirubin (tbil) ≥2.0×uln; 4. triglyceride \>5.7 mmol/l; 5. egfr\<45 ml/(min\*1.73 m\^2); 6. serum amylase and/or lipase ≥3×uln; 7. hemoglobin \<100 g/l; 8. calcitonin≥50 ng/l(pg/ml); * iii. serological examination: 1. human immunodeficiency virus antibody or treponema pallidum antibody is positive; 2. hepatitis c antibody is positive, and hcv rna was higher than the lower limit of the detection reference range; 3. 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; * 18. known allergy to the test drug, empagliflozin, or related excipients; * 19. subjects who have lost more than 400 ml blood due to blood donation or other reasons within 3 months prior to screening; * 20. 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); * 21. subject participated in any drug or medical device clinical study within 3 months prior to screening (except for screening failure); * 22. pregnant or lactating female; * 23. not suitable for this study in the investigator's opinion.