Type 2 Diabetes Mellitus
Conditions
Interventions
Dapagliflozin treatment group:Dapagliflozin
Metformin treatment group:Metformin
Dapagliflozin+Metformin treatment group:Dapagliflozin+Metformin
Intensive insulin therapy group:Insulin Mendon Injection+Insulin Glargine Injection
Duolapeptide Injection treatment group:Duolapeptide Injection
Sponsors
Jiangsu Hospital of Integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-65 years; (2) No limitation on gender; (3) Onset of type 2 diabetes (course <=3 years), never use hypoglycemic drugs to control blood sugar, poor diet and exercise control; (4) 18.5 kg/m2 <= BMI <= 40 kg/m2; (5) 6.5 % <= HbA1c <= 10%; (6) Able to understand the procedures and methods of this study, willing to complete this study in strict compliance with the clinical trial party, and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: General exclusion criteria: (1) Patients with severe diabetic complications, including severe diabetic nephropathy, diabetic foot and diabetic retinopathy (fundus hemorrhage, which affects vision); (2) Patients with serious organ diseases or other serious primary diseases, such as liver and kidney dysfunction, heart failure, cerebral infarction, malignant tumor, etc.; (3) Those with severe cognitive dysfunction and unclear language expression; (4) persons with mental illness; (5) Severe chronic infection; (6) History of AIDS and drug abuse; (7) Pregnant or lactating women; (8) Participating in another clinical study trial; (9) Blood donation or blood loss >= 400 mL within 4 weeks before screening, or blood transfusion received; (10) The investigator believes that the subject has any other factors that may affect the efficacy or safety evaluation of this study. Exclusion criteria for laboratory tests: (1) fasting plasma/serum glucose > 15 mmol/L; (2) AlANINE aminotransferase >= 2.5 x ULN and/or alanine aminotransferase >= 2.5 x ULN and/or total bilirubin >= 1.5 x ULN; (3) Hemoglobin 1.5 x ULN; (7) myocardial enzyme spectrum (creatine kinase CK and creatine kinase isoenzyme ck-mb) > 3 x ULN; (8) Fasting triglyceride >= 5.64 mmol/L (500 mg/dl); (9) Blood amylase and lipase exceeded the upper limit of the normal range and were clinically significant according to the judgment of the researchers; (10) Any laboratory outliers of clinical significance that the investigators believe may interfere with interpretation of the efficacy and safety data in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reverse rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c;FPG;2hPG;FCP;2hCP;Fasting insulin;Insulin 2 hours after meal;HOMA-IR;HOMA-ß;Weight;BMI;Body fat percentage;Waistline;Blood pressure;Heart rate;TG, TC, LDL-c, H-LDL-c;Abdominal ultrasonography;Intestinal flora;Metabolomic indicators; | — |
Countries
China
Contacts
Public ContactLiu Chao
Jiangsu Hospital of Integrated Traditional Chinese and Western Medicine
Outcome results
None listed