Type 2 Diabetes
Conditions
Interventions
10mg group:10mg GMA102
20mg group:20mg GMA102
30mg group:30mg GMA102
Sponsors
Nanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 60 yearsmale or female; 2. Patients with type 2 diabetes WHO meet the world health organization (WHO) criteria for the diagnosis of diabetes in 1999 and meet one of the following conditions:1. patients with type 2 diabetes WHO have not received systematic treatment within three years and control their blood glucose only through diet or exercise; 2. Intensive treatment <=2 weeks; Or receive 1 or 2 oral Antidiabetics Medicine (OAM) to control blood glucose stability for 3 months, and receive more than 2 OAMs (Insulin should not be used within 30 days before screening and continuously used for no more than 7 days within 3 months before screening) during screening, requiring a 3-week washout period(permitted OAMs: Metformin, Sulfonylureas, Glinides, ?-glycosidase inhibitors); 3. HbA1c 7% to 10.5%; 4. Body Mass Index (BMI) 19 to 35 kg/m2; 5. Eligible fertile patients (male and female) must agree to use a reliable method of birth control or prevention during the trial; 6. Willing and able to perform self-blood-glucose-monitoring (SMBG), Willing and able to maintain a subject paper diary ; 7. Subjects must give informed consent to the study before the test and sign the informed consent form; 8. The subjects are able to communicate well with the researchers and complete the study in accordance with the study regulations.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes; 2. Insulin use: (1) Any insulin use within 30 days prior to Screening; (2) >7 days of consecutive insulin use in the 3 months prior to Screening; 3. Use of any GLP-1 analogue and/or DPP4 inhibitor within the last 3 months; 4. Fasting c-peptide 2 times upper limit of normal (ULN); (2) Bilirubin >2 times ULN (except known Gilbert's syndrome with a fractionated bilirubin that shows conjugated bilirubin =5.7mmol/L; (4) Estimated glomerular filtration rate 450ml) or blood transfusion during the three months prior to screening 8. Suspected active infection; 9. Growth hormone therapy was performed within 6 months prior to screening; 10. Patients who received corticosteroids within 2 months prior to screening received intravenous, oral, and intra-articular administration for a long period (more than 7 consecutive days); 11. The screening was preceded by the use of a weight control drug within 2 months or by surgery that can lead to weight instability, or by current weight loss programs that are not in the maintenance phase; 12. The results of electrocardiogram examination were abnormal and determined by the researchers to be unsuitable for this study; 13. Systolic blood pressure (SBP) > 150mmHg and/or diastolic blood pressure (DBP) > 90mmhg after a history of hypertension and steady dose (at least 4 weeks) of antihypertensive medication; 14. A history of acute and chronic pancreatitis, a history of gallbladder disease with symptoms, a history of pancreatic injury and other high risk factors for pancreatitis; Amylase > 1.2 ULN during screening; 15. A history of myeloid C cell carcinoma, MEN (multiple endocrine neoplasms) 2A or 2B syndrome, or a family history; Malignant patient; 16. There are clinically significant abnormal gastric empitation (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as active ulcer within 6 months), long-term use of drugs that have a direct impact on gastrointestinal motility, or gastrointestinal surgery; 17. obvious diseases of the blood system (such as aplastic anemia, myelodysplastic syndrome) or any diseases that cause hemolysis or unstable red blood cells (such as malaria); 18. patients with thyroid dysfunctions (such as thioureas and thyroid hormone drugs) whose treatment dose is not stable within 6 months before screening;With poorly controlled hypothyroidism or a history of hypothyroidism; 19. associated with haemoglobin diseases (such as sickle cell disease) that may affect HbA1c levels; 20. hepatitis b surface antigen (HBsAg), hepatitis c antibody (hcv-ab), immunodeficiency virus antibody (hiv-ab) and syphilis spirochete antibody (tp-ab) were positive; 21. patients with severe mental illness; 22. a history of drug abuse and alcohol abuse within two years; 23. a history of organ transplantation, or other acquired or congenital immune system diseases; 24. known allergy to the active ingredient or excipient of the test drug; 25. subjects who have participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration;Immunogenicity of anti-drug antibodies;Adverse Event;Safty; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood-glucose;Weight;HbA1c;C - peptide;Blood pressure;Lipid;Mixed meal tolerance test;SMBG; | — |
Countries
China
Contacts
Public ContactDa Long Zhu
Nanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School)
Outcome results
None listed