Type 2 diabetes
Conditions
Interventions
experimental group:Liraglutide injection
control group:Novol injection
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent has been obtained prior to performing any test related activity (test related activity refers to any operation that is part of the study, including the activity of determining the eligibility of the subject); 2. Aged between 18 and 75 years(including 18 and 75 years); 3. Type 2 diabetes >= 6 months according to WHO diagnostic criteria; 4. Patients with poor blood glucose control for at least 8 weeks before randomization with stable dose of metformin monotherapy (daily dose >= 1500 mg); 5. HbA1c >= 7.0% and <= 11.0%.
Exclusion criteria
Exclusion criteria: 1. Have type 1 diabetes, special type diabetes, secondary diabetes; 2. A history or family history of multiple endocrine adenoma syndrome type II (MEN2) or medullary thyroid carcinoma (MTC); 3. People who are known or suspected to be allergic to Liraglutide injection (or its components) and GLP-1 drugs; 4. Impair of liver function, defined as alanine aminotransferase or aspartate aminotransferase >= 2.5 times the upper normal range, and/or total bilirubin >= 1.5 times the upper normal range; 5. Impairment of renal function, glomerular filtration rate 1.5 mg/ dL; 6. Calcitonin >= 50 ng/L during screening; 7. Cardiovascular disease, defined as: congestive heart failure (NYHA Grade III-IV), diagnosed as unstable angina, stroke and/or myocardial infarction within the first 6 months of screening; Or coronary, carotid, or peripheral artery revascularization is planned; 8. Uncontrolled/untreated hypertension (systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 100 mmHg) during the screening period; Or previously treated uncontrolled/untreated hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg); 9. Severe hypoglycemic events or unconscious hypoglycemia occurred repeatedly before screening, as judged by the investigator; 10. Screening for more than two ketoacidosis events or episodes of hyperglycemia and hyperosmolarity requiring hospitalization within the previous 6 months; Proliferative retinopathy or macular degeneration (macular edema) requiring urgent treatment prior to randomization; 12. Active or clinically significant gastrointestinal diseases; 13. Previous history of pancreatitis (acute or chronic), pancreatitis at the time of screening, serum amylase =3 times the upper limit of the normal range, or triglyceride >= 5.6mmol/L; 14. Fasting blood glucose >= 11.1mmol/L; 15. Abnormal hemoglobin test results in the laboratory; 16. Had received insulin therapy within 3 months prior to screening (cumulative use of insulin for more than 7 days); 17. Screening treatment with glucagon-like peptide-1 receptor agonist or dipeptidase-4 inhibitor within the first 3 months; 18. Orlistat had been used within 60 days before screening, or there was a weight difference of more than 10% between the induction period and the screening period; 19. During the screening period and the introduction period, any drugs considered by the researchers that may affect the blood glucose concentration except for the oral hypoglycemia prescribed by the protocol should be used; 20. Pregnant and lactating women; Who have a pregnancy plan throughout the trial period and are unwilling to use one or more non-drug contraceptive methods (such as complete abstinence, intrauterine devices, partner ligation, etc.); 21. Any clinically significant and researchers think that may affect the test result of disease or condition, such as: with history of hemoglobin, hemolytic anemia, or a history of sickle cell anemia, a history of malignancy or history of thyroid related tumor known thyroid nodule TI - RADS classification 4 classes and above, or a history of cancer patients with a history of cancer, known to patients with a history of alcoholism, drug addiction or drug abuse, 3 months prior to screening blood transfusion or serious bleeding; 22. Patients who are not suitable to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of HbA1c compared with baseline; | — |
Countries
China
Contacts
Public Contactranxinwu
West China Hospital, Sichuan University
Outcome results
None listed