Diabetes type 2
Conditions
Interventions
Adult patients with type 2 diabetes mellitus (T2DM) using traditional oral antidiabetic regimens.:NA
Adult patients with type 2 diabetes mellitus (T2DM) using Henagliflozein or its fixed-dose combination (FDC).:NA
Sponsors
Hunan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age range: >=18 years old; 2. BMI range: >= 19 kg/m and =6.5%; 4. Clinically diagnosed as type 2 diabetes (in line with the diagnostic criteria of China guidelines for the prevention and treatment of type 2 diabetes, 2020 edition). 5. Have taken Henagliflozein or its FDC. 6. Willing to sign the informed consent form before the start of the activities related to this trial, and being able to understand the procedures and methods of this trial, willing to strictly abide by the clinical trial plan to complete this trial.
Exclusion criteria
Exclusion criteria: 1. Women during pregnancy and lactation and women of childbearing age who are unwilling to take reliable contraceptive measures. 2. Minors, mental patients, critically ill patients and people with cognitive impairment. 3. Patients with drug abuse or addiction; 4. Type 1 diabetes mellitus; 5. Allergic to the active ingredients of Henagliflozein or any auxiliary materials. 6. AST or ALT is more than 3 times the upper limit of normal value. 7. Patients with GFR =160 mmHg and/or diastolic blood pressure >=100 mmHg (mean of three blood pressure measurements in the supine position) during the screening visit. 12. Symptomatic hypotension and/or systolic blood pressure <90 mmHg at Visit 0 or Visit 1, or patients judged by the clinician to be hypovolemic. 13. Life expectancy of less than 1 year during the screening period. 14. Patients with malignant tumors, active tuberculosis, or acute infections. 15. The investigator determines that the patient has other conditions that are not suitable for enrollment. 16. Patients who have participated in other clinical trials within 3 months. 17. In addition to the above, patients whom the investigator deems unsuitable for participation in this clinical trial. 18. Patients with a history of recurrent urinary and reproductive tract infections (judged by clinicians);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c?Body weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose, fasting insulin, fasting C-peptide, postprandial 2-hour blood glucose, liver function, renal function, blood lipid profile, complete blood count.;Urine albumin-to-creatinine ratio (UACR), urinalysis.; | — |
Countries
China
Contacts
Public ContactChi Zhang
Hunan Provincial People's Hospital
Outcome results
None listed