Type 2 Diabetes Mellitus
Conditions
Interventions
Group 1:Subcutaneous injection therapy with insulin aspart 30.:The initial total dose is 0.3U-0.5U/Kg, 2 /day, subcutaneous injection before breakfast and dinner, adjusted according to the blood gluco
Group 2:Triple oral hypoglycemic therapy based on metformin, dapagliflozin plus saxagliptin. Adjusting dose according to the blood glucose level
Sponsors
Zhujiang Hospital, Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The newly-diagnosed type 2 diabetes mellitus according to the 1999 WHO guideline on diagnosing type 2 diabetes mellitus; 9%=HbA1c=12%; 2. Aged 18-65 years old, Men or women; 3. Voluntarily taking the triple combination therapy using metformin, saxagliptin plus dapagliflozin or premixed insulin therapy, without taking any other hypoglycemic therapy before; 4. 18.5kg/m2?BMI?32 kg/m2; 5. Voluntarily participating in our study and insisting on monitoring blood glucose at least one day a week, and finishing re-examation and sign of informed consent after three month.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes mellitus, or islet dysfunction (fasting C-peptide 3 times the normal upper limit (ULN) or serum total bilirubin (TB)> 34.2 µmol/L (> 2 mg / dL); 6. 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) the serum (Cr) =133 µmol/L (=1.50 mg/dL) in male subjects; the serum Cr=124µmol/L (> 1.40 mg/dL) in female subjects; (5) congenital renal glucosuria; 7. Poor control of Severe hypertension, SBP = 160 mmHg and / or DBP = 100 mmHg; SBP <96 mmHg; 8. Patients with myocardial infarction / unstable angina / severe arrhythmia / heart failure in the past 3 months; 9. Hb=110g/L in female subjects and Hb=120g/L in male subjects; 10. Pregnant women or women who are planning to be pregnant during the study, women who are currently in lactation, or who having not adopted highly effective, medical-approved birth control methods. 11. Gastrointestinal diseases or surgical history, including Roemheld syndrome, severe hernia, intestinal obstruction, intestinal ulcers, gastrointestinal anastomosis, bowel resection, weight loss surgery or banding surgery; 12. Taking any drugs that affect blood sugar, body weight and history of drug abuse, alcohol or drug abuse over the past 6 months; 13. Patients who have received organ transplants or who have been definitely diagnosed as immunodeficiency syndrome with low immune function; 14. With a history of hypersensitivity or contraindication to metformin, saxagliptin, dapagliflozin and other researched drugs; 15. Patients that might not follow this program, or with severe physical/mental illness that may affect effectiveness or safety, based on the judgement of investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood glucose;Body weight;Incidence rate of hypoglycemia; | — |
Countries
China
Contacts
Public ContactJia Sun
Department of Endocrinology and Metabolism, Zhujiang Hospital, Southern Medical University
Outcome results
None listed