Type 2 Diabetes
Conditions
Interventions
TG103 15mg group:TG103 (15 mg) will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes combined with overweight/obesity.
TG103 22.5mg group:TG103 (22.5 mg) will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes combined with overweight/obesity.
TG103 30mg group:TG103 (30 mg) will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes combined with overweight/obesity.
Placebo group:Placebo will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes will be administered via subcutaneous injection once weekly.
Sponsors
Nanjing Drum Tower Hospital Affiliated to Medical College of Nanjing University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion 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); 2.Aged 18 to 75 years (inclusive), no gender limitation; 3.Body mass index (BMI) >= 24.0 kg/m^2 with stable body weight (less than 5% self-reported change within 3 months); 4. Subjects diagnosed with type 2 diabetes <= 3 years, and not on medication or with a history of regular medication for no more than 1 week within the 3 months prior to screening (subjects with a history of medication only include those with a history of single-agent oral medication and a history of short-term intensive insulin therapy (<= 2 weeks)); 5.7.5% <= HbA1c <= 10.0%; 6.Subjects of childbearing potential must use reliable methods of contraception from the date of signing an informed consent to at least 3 months after the last dose; 7.?The subject fully understand the trial and possible adverse reactions, has the ability to communicate properly with the investigator and comply with the research protocol; 8.Voluntarily participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Fasting plasma glucose >= 13.9 mmol/L at screening or a history of severe hypoglycemia (Serious event requiring help from others with changes in consciousness and/or body) within 6 months prior to screening; 2.Systolic blood pressure >= 160 mmHg or diastolic blood pressure >=100 mmHg during screening; 3.Have one or more positive tests in anti-human immunodeficiency virus antibody or anti-treponema pallidum-specific antibody; 4.Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >=2.5x upper limit of normal (ULN), or Total bilirubin (TBiL)>=1.5x ULN, or triglyceride > 5.7 mmol/L or eGFR = 50 ng/L(pg/mL); 8.?Acute complications of diabetes (including diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis) occurred once or more within 3 months or twice or more within 6 months before screening; 9.Proliferative diabetic retinopathy, foot ulcers/gangrene, and manifestations of peripheral neuropathy with obvious symptoms (e.g., gastroparesis, urinary retention, intestinal obstruction, urinary incontinence, and painful peripheral neuropathy); 10.Subjects with degree II or III atrioventricular block in 12-lead ECG (except for subjects who use the pacemaker), long QT syndrome or prolonged QTc interval (QTcF: >450 ms for males, >470 ms for females), or signs of clinically significant localised ischemic heart disease during the screening period; or those with other heart diseases that are judged by the investigator to be unsuitable for entry into the study; 11.Any of the following cardiovascular and cerebrovascular events within half a year before screening: unstable angina pectoris requiring hospitalization, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention (diagnostic angiography is allowed), moderate to severe congestive heart failure (NYHA grade III or IV), atrial or ventricular arrhythmia requiring hospitalization (such as atrial fibrillation and ventricular tachycardia), pacemaker or defibrillator implantation, transient ischemic attack or cerebrovascular accident (e.g. stroke), or those with coronary artery bypass grafting or revascularization planned during the study period; 12.Have chronic or acute pancreatitis ( or have a history of recurrent acute pancreatitis), or serum amylase and/or lipase = 3x ULN (If lipase cannot be detected in some centers, it is acceptable to judge only based on amylase),or severe gastrointestinal disease, such as confirmed reflux esophagitis or gallbladder disease, or any disease impacting gastric emptying (such as gastric bypass surgery, pyloric stenosis, except for appendectomy) or gastrointestinal diseases that may be aggravated by GLP-1 analogues; for subjects with a history of gallbladder stones (gallstone removal or lithotripsy) and/or cholec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin; | — |
Countries
Chian
Contacts
Public ContactZhu Dalong
Nanjing Drum Tower Hospital Affiliated to Medical College of Nanjing University
Outcome results
None listed