Type 2 diabetes mellitus
Conditions
Interventions
treatment group:Sodium-glucose cotransporter-2 inhibitor therapy
control group:sulfonylureas
Sponsors
Department of Endocrinology, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Clinical diagnosis of T2DM; (2) Gender: male or postmenopausal female; (3) Age:18-75 years old; (4) Body weight: male = 50.0kg, female = 5.0kg, BMI 19-28kg/m2; (5) HbA1c: 7%-11%; (6) Treated with a stable dose of metformin for at least 3 months; (7) Fully understand the test content, process, possible adverse reactions and test risks, and voluntarily sign informed consent before screening, and agree to complete the study in accordance with the requirements of the test plan.
Exclusion criteria
Exclusion criteria: (1) T1DM or other types of diabetes mellitus; (2) There is an absolute contraindication for dagliazine, an SGLT-2 inhibitor: individual characteristics of any drug component; Diabetic ketoacidosis; Moderate to severe kidney disease (eGFR <60 ml/min /1.73m2) or end-stage renal failure; Hereditary lactose intolerance, lactase deficiency, glucose and galactose intolerance; Patients receiving loop diuretics or reduced blood circulation; History of urinary tract infection; (3) History of gastrointestinal disease, cholecystectomy, or other biliary tract related disease; (4) Elevated liver transaminase ALT and/or AST were more than 3 times higher than the normal value; (5) A history of moderate or severe congestive heart failure within 3 months prior to screening; (6) previous use of DPP-IV inhibitors or GLP-1 receptor agonists; (7) Used lipid-lowering drugs within three months; (8) People with a history of specific allergies (such as asthma, urticaria, eczema, etc.), or allergic conditions (such as allergy to two or more drugs, foods such as milk and pollen), or known allergy to SGLT-2I or sulfonylureas, or any related excipients; (9) Antibiotics, probiotics, prebiotics, etc., have been used within three months; (10) participating in another clinical trial; (11) Participants considered unsuitable for clinical trials by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum bile acid;Fecal bile acid;blood lipid level;Color ultrasound of liver, bile, pancreas and spleen; | — |
Secondary
| Measure | Time frame |
|---|---|
| fasting blood glucose;glycosylated hemoglobin;oral glucose tolerance test;body composition; | — |
Countries
China
Contacts
Public ContactYu Liu
Department of Endocrinology, Sir Run Run Hospital, Nanjing Medical University
Outcome results
None listed