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:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT03717194
Eligibility Criteria:
Inclusion Criteria:
* Patients with T2D taking oral antidiabetic medications (metformin and/or DPP4 inhibitors) except SGLT2 inhibitors for at least 12 weeks without a dose adjustment before enrollment.
* eGFR ≥ 45 mL/min/1.73 m2.
* Stage B HF identified on the basis of either structural or functional markers.
Exclusion Criteria:
* Type 1 diabetes mellitus
* At the time of screening age \<20 years
* HbA1c \<7% or HbA1c \>9.5% at Screening
* FPG \>15 mmol/L (270 mg/dL) measured by the laboratory at Screening (Visit 1), and confirmed (\>15 mmol/L \[\>270 mg/dL\]) by a repeat test before randomization
* Treated with insulin and/or GLP-1R agonist within 12 weeks preceding the Screening Visit.
* Women of childbearing potential with no effective contraceptive method
* History of gastric surgery including history of gastric banding within 3 years before the Screening Visit
* History of diabetic ketoacidosis or nonketotic hyperosmolar coma prior to the Screening Visit
* Mean blood pressure after 3 separate measurements \>180 mmHg in systolic blood pressure (SBP) or \>95 mmHg in diastolic blood pressure (DBP)
* Patients with current or prior symptoms of HF.
* Patients with severe anemia, severe respiratory, hepatic, neurological, psychiatric disorders or active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult
* Aspartate aminotransferase and/or alanine aminotransferase: \>3 times the upper limit of the normal laboratory range (ULN)
* Total bilirubin: \>1.5 times ULN (except in case of Gilbert's syndrome)
* Use of systemic glucocorticoids (excluding topical or ophthalmic, application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit
* Patient who has taken other investigational drugs or prohibited therapy for this study within 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT03717194
Study Brief:
Protocol Section:
NCT03717194