type 2 diabetes
Conditions
Interventions
Experimental Group:pioglitazone-metformin (FDC) + dapagliflozin
Control group:basal insulin + metformin
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Aged between 18 to 75 years old; (2) BMI 19 to 35; (3) Type 2 diabetes patients (WHO standard, 1999); (4) Newly diagnosed patient (diagnosed as type 2 diabetes within three months before enrollment, and no medication was given), or previous use of hypoglycemic drugs (exclude the use of TZDs, SGLT-2 inhibitors, insulin, or oral drugs within six months More than 3 types), patients with stable treatment for >=3 months and inadequately controlled(HbAlc 8 to 11%); (5) Volunteer to participate in the clinical study and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Type 1 diabetes or other special types of diabetes; (2) Abnormal liver function, with ALT and AST higher than 2.5 times the upper limit of normal; (3) Renal function damage, glomerular filtration rate =133umol/L, males >=135umol/L; (4) Fasting C-peptide =180mmHg and/or DBP>=110mmHg; (8) White blood cell count <=3.0x10^9/L or platelet count <=60x10^9/L, or clear anemia (hemoglobin: male <120g/L, female <110g/L), or other blood system diseases; (9) Endocrine system diseases, such as hyperthyroidism, hypercortisolism, etc.; (10) allergic to test drugs or have frequent hypoglycemia; (11) with mental illness, drug or other substance abuse; (12) Insulin is needed to treat patients with diabetic ketoacidosis and hyperosmolar non-ketotic coma; (13) Chronic hypoxic diseases such as emphysema and pulmonary heart disease; (14) Combined use of drugs that affect glucose metabolism, such as glucocorticoids; (15) Tumor patients, especially bladder tumors, and/or family history of bladder tumors, and/or long-term history of hematuria; (16) Those with a history of osteoporosis or a history of non-violent fracture; (17) Those who are pregnant or breastfeeding or have the intention to become pregnant; (18) Those who have participated in other drug clinical trials within three months; (19) Patients considered by the investigator to be unsuitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite End Points;the incidence of adverse events such as hypoglycemia; | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c;FPG;2hPG;FCP;BP;TG, TC, FFA, HDL-C, LDL-C;CRP, IL-6;Weight;BMI;BNP;Echocardiography;BGP, CTX; | — |
Countries
China
Contacts
Public ContactYongde Peng
Shanghai General Hospital
Outcome results
None listed