Type 2 diabetes
Conditions
Interventions
Experimental group:Dapagliflozin(Anda don) 10mg once after breakfast increase Metfomin 500mg twice after breakfast and dinner,if glucose controls poor,metformin can be added to 1000mg twice after brea
Control group:Acarbose (Bai Tang) 50 mg three times at the same time of three meals increase Metfomin 500mg twice after breakfast and dinner,if glucose controls poor,metformin can be added to 1000mg
Sponsors
Zhujiang Hospital, Southern Medical University
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects included in the study should meet the following criteria: 1. Men and women are eligible at the age of 20-75 years old; 2. Newly diagnosed with type 2 diabetes without oral hypoglycemic agents or insulin therapy, or patients with type 2 diabetes treated with monotherapy (metformin) but poor glycemic control.[Newly diagnosed with type 2 diabetes:without diabetes history, never treated with hypoglycemic treatment, meet the diagnostic criteria for type 2 diabetes once founded at the first time]. [Poor glycemic control for type 2 diabetes patients with metformin monotherapy : patients with type 2 diabetes after metformin monotherapy but glycated hemoglobin was still >7% . 3.3.7.0% = glycated hemoglobin level (HbA1) = 10.5%; 4. fasting C peptide level > 1nmol / L; 5. Voluntary participation and cooperation research and signed informed consent.
Exclusion criteria
Exclusion criteria: The subject may should not be included in this study if any of the following exclusion criteria are met: 1.Type 1 diabetes or secondary diabetes; 2. Patients with severe diabetic complications such as diabetic ketoacidosis, hyperosmolar hyperglycemia syndrome, lactic acidosis; 3. Patients with clinically significant hepatobiliary disorders, including but not limited to chronic active hepatitis and/or severe liver dysfunction, cirrhosis. ALT or AST>3 times the normal upper limit (ULN) or serum total bilirubin (TB)>34.2µmol/L(>2 mg/dL);4.Patients with the following nephrotic history or kidney disease-related characteristics: 1) History of unstable or acute kidney disease; 2) Patients with moderate/severe renal injury or end-stage renal disease (eGFR 1800 mg/g; 4) Serum creatinine (Cr)=133µmol/L (=150mg/dL) in male subjects; the serum Cr=124µmol/L(>1.40mg/dL) in female subjects; 5.Any of the following cardiovascular diseases occured in the last 6 months: 1) Myocardial infarction; 2)cerebral infarction; 3) Cardiac surgery or revascularization (coronary artery bypass surgery/percutaneous transluminal coronary angioplasty); 4) Unstable angina; 5) Congestive heart failure (New York Heart Society grade III or IV); 6) Transient ischemic attack or significant cerebrovascular disease; 6.Gastrointestinal diseases or surgical history, including intestinal obstruction, intestinal ulcers, weight loss surgery or banding surgery, gastrointestinal anastomosis, bowel resection; 7.Pregnant women or women who are currently in lactating;8.Urinary tract infection in the past 2 weeks;9.. In the case of a researcher's judgment, it is not possible to follow the program's subject, and there are patients with severe physical or mental illness that may affect effectiveness or safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated Hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute Changes of BMI;Glucose Metabolism Index;Serum Lipid;Adipocytokines;Ratio of HbA1c=7.0%;Proportion of Hypoglycemic Patients;Blood Pressure;Liver Function;Renal Function; | — |
Countries
China
Contacts
Public ContactHong Chen
Department of Endocrinology and Metabolism, Zhujiang Hospital, Southern Medical University
Outcome results
None listed