Newly diagnosed type 2 diabetes mellitus
Conditions
Interventions
1:dapagliflozin+intensive insulin therapy
2:intensive insulin therapy
Sponsors
Tungwah Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. sign written consent form to participate in the study and comply to the requirements of the study; 2. men and women aged 18-70 years; 3. diagnosed with type 2 diabetes mellitus based on the 2013 Standards of Care for Type 2 Diabetes in China; 4. no previous administration of any antidiabetic therapy, including oral agents and insulin.
Exclusion criteria
Exclusion criteria: 1. individuals considered at risk for poor study compliance; 2. patients who had severe acute diabetic complications, including diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome; 3. patients with known serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of the normal range (ULN), or had severe hepatic insufficiency; 4. eGFR<60ml/min/1.73m2 assessed using an abbreviated Modification of Diet in Renal Disease (MDRD) equation and indexed to 1.73m2; 5. positive for autoimmune antibodies against islets; 6. recent history of being treated with corticosteroid, immunosuppressing drugs, or cytotoxic drugs; 7. history of cushings syndrome, acromegaly, hyperthyroidism, etc.; 8. history of malignancy, serious infection, severe malnutrition, etc.; 9. allergy or contraindication to the contents of dapagliflozin tablets; 10. patients considered unsuitable subjects by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HOMA-IR;HOMA-beta;?I30/?G30;AUCi; | — |
Secondary
| Measure | Time frame |
|---|---|
| Heamoglobin A1c;Fasting Plasma Lipid;Blood Pressure;Hypoglycemia Incidence;Adverse Event; | — |
Countries
China
Contacts
Public ContactMin Lin
Outcome results
None listed