Type2 diabetes
Conditions
Interventions
Test group:Drug name: Liraglutide injection
Dosage form: injection
Specification: 3ml: 18mg
Route and site of administration: subcutaneous injection, the injection site can be abdomen, thigh or upper
Sponsors
First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-70 years old (including boundary values), both male and female; 2) Diagnosed with type 2 diabetes according to WHO diagnostic criteria; 3) Patients who can use liraglutide injection according to clinical conditions; 4) 7% <=HBA1c<=10%, and fasting venous blood glucose <=11.1mmol/L; 5) On the basis of insulin treatment of poor blood glucose control, it can be added to this product or islet in the treatment of intolerant type 2 diabetes patients who can be replaced by this product; 6) The subjects voluntarily joined the study, signed the informed consent, had good compliance, and were followed up.
Exclusion criteria
Exclusion criteria: 1) Clinically diagnosed as type 1 diabetes mellitus; 2) A history or family history of type II multiple endocrine adenoma syndrome (MEN2) or medullary thyroid carcinoma (MTC); 3) Known or suspected allergy to liraglutide injection (or its components), GLP-1 drugs; 4) A history of pancreatic cancer, acute or chronic pancreatitis, or acute or chronic pancreatitis at screening, or blood amylase and/or lipase>=3 times the upper limit of normal, or calcitonin>= 50 pg/ml, or fasting triglyceride >=5.7 mmol/L; 5) Previous or current hypothyroidism or hyperthyroidism; 6) Suffering from systemic diseases such as systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, myasthenia gravis, etc. 7) Ketoacidosis, diabetic lactic acid poisoning or hyperosmolar non-ketotic coma occurred within the last 6 months, requiring hospitalization; 8) Patients with gastrointestinal diseases (such as Roemheld syndrome, severe hernia, intestinal obstruction, postoperative bowel surgery, and intestinal ulcers) that may be aggravated by flatulence; 9) Liver disease, liver function ALT or AST > 3×ULN or TBil > 2×ULN; 10) In patients with kidney disease, glomerular filtration rate 1.5×ULN; 11) History of heart failure (NYHA class III or ?), or history of acute myocardial infarction or unstable angina pectoris in the 6 months prior to screening; have a history of coronary angioplasty, coronary stenting, or coronary bypass surgery within 6 months prior to screening, or have a recent heart surgery plan; or prolonged QTc interval >=500 ms; 12) Patients with acute complications of diabetes (such as ketoacidosis, hyperosmolar hyperglycemic confusion, lactic acidosis, etc.) or serious chronic complications (diabetic retinopathy stage IV and above or diabetic nephropathy stage IV and above); 13) Severe hypoglycemic events with unknown causes have occurred within the last 6 months (need help from others to recover); or frequent hypoglycemia: such as two or more hypoglycemic events (blood sugar <=3.9mmol/L) within 1 month before screening; 14) Suffering from serious diseases of vital organs, including but not limited to cardiovascular, lung, liver, kidney, or other uncontrollable diseases; 15) Pregnancy, during the trial women who are planning to become pregnant or breastfeeding, or eligible subjects (male and female) who are fertile do not consent to the use of reliable contraceptive methods during the trial and for at least 1 month after the last dosing; 16) A history of diseases that may cause hemolysis or erythrocyte instability affecting the HbA1c test, such as hemoglobin diseases (e.g. Sickle cell anemia or thalassemia, sideroblastic anemia); 17) Have any type of malignant tumor (whether cured or not); 18) Participated in clinical trials of other scientific drugs or medical devices within 1 month before signing the informed consent; 19) Alcohol or drug users.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting venous glucose;Fasting c-peptide;Weight-related indicators (waist circumference, hip circumference, height, weight);Lipid-related indicators: (TC, TG, HDL-C, LDL-C);Pancreatic islet function indicators (HOMA-ß, HOMA-IR, MBC);Safety indicators (ECG, blood, urine routine, blood biochemistry (liver function: ALT, AST, TBil, AKP, ?-GT; , renal function: BUN, Cr, Ccr, UA), pregnancy test);Fasting insulin;Insulin 2 hours after a meal;Proportion of subjects with adverse reactions;Venous blood sugar 2 hours after a meal;C-peptide 2 hours after meal; | — |
Countries
China
Contacts
Public ContactLi Huifang
First Affiliated Hospital of Kunming Medical University
Outcome results
None listed