Type 2 diabetes
Conditions
Interventions
Experimental group:Coagliptin tablets, 10 mg, once every two weeks (14 days), orally.
Sponsors
Ningbo University First Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Be able to understand and voluntarily sign the written Informed Consent Form (ICF); 2. Age: 18 to 70 years old (including 18 and 70 years old), gender not limited. 3. Newly diagnosed type 2 diabetes patients who meet the criteria of the "Chinese Diabetes Prevention and Control Guidelines (2024 Edition)" (diagnosis established =9.0% or FPG>=11.1 mmol/L, or accompanied by obvious hyperglycemic symptoms; 4. Body mass index (BMI) is between 24.0 kg/m ² and 35.0 kg/m ² (including the critical value); 5. After signing the informed consent form, the intensive treatment of standardized insulin combined with metformin as stipulated in the protocol was completed. Without using any hypoglycemic drugs, the blood glucose levels met the following requirements: fasting blood glucose < 6.1 mmol/L, 2-hour postprandial blood glucose < 8.0 mmol/L.
Exclusion criteria
Exclusion criteria: 1. There is a known history of allergy to the components of the investigational drug or other drugs or excipients with similar chemical structures; 2. History of diabetic ketoacidosis or hyperglycemic hyperosmolar state, type 1 diabetes, pancreatic or ß -cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy; 3. There is severe liver function deficiency (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal value (ULN)), and renal function deficiency (eGFR < 45 mL/min/1.73m^2); Severe cardiovascular and cerebrovascular events such as acute myocardial infarction, unstable angina pectoris, and stroke occurred within 4.6 months; 5. Having received any treatment that may significantly affect weight (such as GLP-1 receptor agonists, weight-loss drugs, etc.), anti-obesity drug treatment or screening within the three months prior to informed consent, or having received any other treatment (such as surgery, aggressive diet plans, etc.) that led to weight instability 6. Being receiving systemic corticosteroid treatment at the time of informed consent, or having changed the dosage of thyroid hormones within 6 weeks prior to informed consent, or any other uncontrolled endocrine disease other than type 2 diabetes mellitus; 7. Women who are pregnant, preparing for pregnancy during research, or breastfeeding; 8. Those with a clear history of alcohol or drug abuse; 9. Unable to cooperate with the visitor; 10. Have participated in any other clinical studies within 30 days prior to screening; 11. The researcher determined that there were other circumstances that made participation in this study unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with HbA1c < 7.0% after 48 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with HbA1c<7.0% after 24 weeks of treatment;The proportion of patients with HbA1c<6.5% after 24 and 48 weeks of treatment;The changes in fasting blood glucose relative to the baseline after 24 and 48 weeks of treatment;The changes in 2-hour postprandial blood glucose relative to the baseline after 24 and 48 weeks of treatment;The changes of insulin resistance (calculated by the HOMA-IR formula) and ß -cell function (calculated by the HOMA-B formula) relative to the baseline after 24 and 48 weeks of treatment;The changes in body weight relative to the baseline after 24 and 48 weeks of treatment; | — |
Countries
China
Contacts
Public ContactLi Jialin
The First Affiliated Hospital of Ningbo University
Outcome results
None listed