Type 2 diabetes
Conditions
Interventions
Positive control group:The initial dose is 0.25mg, administered by subcutaneous injection once a week. The titration scheme is as follows:
Weeks 1-4: 0.25mg
Weeks 5-8: 0.5mg
Weeks 9-24: 1.0mg
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years at the time of informed consent; sex not restricted. 2. Documented diagnosis of type 2 diabetes mellitus with HbA1c >=7.0% and =50.0 kg for men and >=45.0 kg for women at screening; body-mass index 23.0–40.0 kg/m² . 5. Subject agrees to use effective contraception from screening until 6 months after study completion and has no plans to donate sperm or ova during this period. 6. Has been fully informed about the study and voluntarily signed the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to the investigational product or any of its excipients, to other GLP-1 receptor agonists, or history of clinically significant multiple or severe drug allergies; current allergic disease, high allergic disposition, or history of anaphylaxis. 2. Prior use of any of the following medications: 1) Any antihyperglycemic agent other than metformin within 3 months before screening, including GLP-1 analogues, oral antidiabetics, insulin, Chinese herbal medicines or health products with glucose-lowering effects.2) Systemic glucocorticoids, growth hormone, or any drug that may affect glucose metabolism within 3 months before screening.3) Any weight-loss medication within 3 months before screening. 3. History or evidence of any of the following conditions: 1) Diabetes other than type 2 (e.g., type 1 diabetes, specific types of diabetes).2) Acute or chronic pancreatitis, or history of pancreatic surgery.3) Symptomatic gallbladder disease within 2 years before screening (imaging-confirmed gallstones with physician-diagnosed related abdominal pain); subjects with prior cholecystectomy without sequelae may be included.4) Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.5) Hematologic disorders that may interfere with HbA1c measurement or increase subject risk, or any disease causing hemolysis or red-cell instability.6) History of depression or severe psychiatric disorders including suicidal ideation/attempt, schizophrenia, or bipolar disorder.7) Clinically significant active cardiovascular or cerebrovascular disease within 6 months before screening: myocardial infarction or unstable angina; cardiac surgery; congestive heart failure; cerebrovascular accident including stroke/TIA; any other cardiovascular/cerebrovascular condition deemed unsuitable by the investigator.8) Retinopathy requiring urgent treatment at screening.9) History of severe hypoglycemic coma or recurrent hypoglycemia within 2 months before randomization.10) Diabetic acute metabolic complications or diabetic foot within 6 months before screening.11) Gastroparesis or other disorders associated with delayed gastric emptying, uncontrolled gastro-esophageal reflux disease, or any gastrointestinal condition that, in the investigator’s opinion, increases risk after study drug administration.12) Major surgery, severe trauma, or severe infection within 1 month before screening judged by the investigator to preclude study participation.13) History of malignancy (except adequately treated basal-cell carcinoma or carcinoma in situ of the cervix).14) Concurrent medical conditions (neurologic, endocrine, psychiatric, etc.) that, in the investigator’s opinion, could compromise subject safety, affect efficacy assessments, or interfere with compliance. 4. Clinically significant abnormal findings at screening, including: 1) Fasting C-peptide =2.5×ULN; total bilirubin >=1.5×ULN; eGFR =50 pg/mL.4) Unstable thyroid medication requirement or clinically significant abnormal thyroid function tests necessitating new treatment.5) Fasting triglycerides >=5.6 mmol/L.6) Serum amylase and/or lipase >2.0×ULN.7) INR above the upper limit of normal.8) Hemoglobin <110 g/L (males) or <100 g/L (females).9) Uncontrolled or untreated hypertension.10) Clinically significant ECG abnormalities: second- or third-degree AV block; long-QT syndrome or QT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in HbA1c at Week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to week 12, 16, 20 in HbA1c;Change in venous fasting plasma glucose (FPG) from baseline to week 12, 16, 20, 24;Change in 2-hour post-standard-meal plasma glucose from baseline to week 12, 24;Change in body weight from baseline to week 12, 24;Change in waist circumference from baseline to week 12, 24;HbA1c target achievement rates at Week 24;FPG target achievement rate at Week 24;Combined target achievement rate for both HbA1c and FPG at Week 24;Change from baseline to week 24 in fasting lipid profile;Change from baseline to week 24 in systolic blood pressure;Change from baseline to week 24 in diastolic blood pressure;Change from baseline to week 4,12,24 in blood glucose at 7 o'clock;Change from baseline to week 24 in insulin resistance index and pancreatic ß -cell function indicators; | — |
Countries
China
Contacts
Public ContactZhou Zhiguang
The Second Xiangya Hospital of Central Sounth University
Outcome results
None listed