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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT03059069
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetic patients
* Age ≥ 50
* Glycemic control: HbA1c ≤ 10.0%
* 10 ≤ Beck Depression Inventory (BDI) \<30 points
* Participants who can undergo contraception in case of being in childbearing period
* Understands the study procedure, alternatives, and risks and voluntarily agrees to participate by giving written informed concent
Exclusion Criteria:
* Type 1 diabetes, Secondary diabetes, gestational diabetes
* Ongoing dementia treatment or anti-depressive disorder medication
* Uncontrolled psychiatric disorder
* BDI ≥ 30 points
* Heavy alcoholics
* Underlying chronic liver disease (hemochromatosis, liver cell carcinoma, autoimmune liver disease, liver cirrhosis, chronic viral hepatitis)
* Allergy or hypersensitivity to target medication or any of its components
* Renal failure, moderate or severe renal impairment (estimated glomerular filtration rate \< 30 mL/min/1.73 m2), or ongoing dialysis
* Abnormal liver function (AST/ALT \> x3 upper normal limit)
* History of alcohol or drug abuse in the previous 3 months
* Premenopausal women who are nursing or pregnant
* Human immunodeficiency virus (HIV) or human immunodeficiency virus (AIDS)
* chronic pancreatitis or pancreatic cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03059069
Study Brief:
Protocol Section:
NCT03059069