Type 2 diabetes
Conditions
Interventions
Observation group:None
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old= age = 80 years old; 2. Diagnosed with type 2 diabetes mellitus according to WHO diagnostic criteria, with 7.0% = HbA1c=11.0%, fasting venous blood glucose = 13.3mmol/L; 3. Voluntarily participate in this study and sign the informed consent form. If the subject does not have the ability to read the informed consent form (e.g., illiterate subjects), a witness is required to witness the informed process and sign the informed consent form; 4. Those who meet any of the following two requirements at screening: (1) those who do not use SGLT2i and have poor glycemic control, (2) those who have been discontinued for more than 7 days after using other non-hengagliflozin SGLT2i and have poor glycemic control. (1) The hypoglycemic drugs used by all subjects in China need to be in a stable dose for more than 8 weeks, and (2) the other hypoglycemic drugs except SGLT2i in China need to be in a stable dose for more than 8 weeks.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to the test drug or any of its ingredients; 2. Have participated in clinical trials of other diabetes treatment drugs within 1 month before the start of this study; 3. Those who have had acute metabolic complications (ketoacidosis, lactic acidosis or hyperosmolar coma, etc.) within 6 months; 4. Those who have negligent compensated heart failure (NYHA classification IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, cardiac surgery or revascularization (including coronary artery bypass grafting or percutaneous coronary intervention) within 6 months; 5. Patients with malignant tumors and life expectancy of less than one year, active tuberculosis, and acute infection; 6. Those with a history of current or previous recurrent urinary tract infections and/or genital infections; 7. Patients with a history of hypertension whose blood pressure cannot be effectively controlled after antihypertensive drug treatment: systolic blood pressure (SBP) > 180 mmHg and/or diastolic blood pressure (DBP) >110 mmHg; 8. Renal function indexes meet the following criteria: eGFR<30 ml/min/1.73 m2 (calculated according to the Cooperative Study on Epidemiology of Chronic Kidney Disease [CKD?EPI] formula); 9. Male or female of childbearing potential who are unwilling to contraceptive during the trial, pregnant or lactating women; 10. In addition to the above, patients judged by the investigator to be unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose;Blood glucose 2 hours postprandial;Blood uric acid;blood lipids;Blood metabolism indicators; | — |
Countries
China
Contacts
Public ContactZhu Hong
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed