Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT04014192
Eligibility Criteria:
Inclusion Criteria:
* (1)According to the diagnostic criteria of World Health Organization (WHO) in 1999, type 2 diabetes mellitus was diagnosed clinically. The age ranged from 18 to 70 years (including 18 and 70 years). There was no limit to the duration of diabetes mellitus and gender.
* (2)Basic antidiabetic therapy is not limited.
* (3)HbA1c ≥ 7%.
* (4)eGFR ≥60 ml/min；without contraindications to SGLT2 Inhibitors.
* (5)Sign written consent form voluntarily.
Exclusion Criteria:
* (1)Other types of diabetes mellitus.
* (2)Unstable control of blood glucose(fasting blood glucose \> 11.1 mmol/L).
* (3)Acute complications of diabetes mellitus within 6 months.
* (4)History of myocardial infarction or stroke within 6 months, or existing severe cardiovascular disease and risk.
* (5)Abnormal liver function \[i.e. serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is 1.5 times higher than the upper limit of normal value\].
* (6)Severe hypertension that defined as systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥90 mmHg with drug therapy, or hypotension (resting seat blood pressure \< 90/50 mmHg).
* (7)psychosis, alcohol dependence or history of drug abuse, lactation women, participation in other studies three months before the trial, allergic constitution or allergic to a variety of drug and those researchers think inappropriate to the research.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04014192
Study Brief:
Protocol Section:
NCT04014192