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 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT02285205
Eligibility Criteria:
Inclusion Criteria:
1. Type Ⅱ diabetes mellitus
2. Non-alcoholic fatty liver disease: subjects who have CAP(Controlled Attenuation Parameter) ≥ 250dB/m measured by transient elastography (fibroscan) at screening test
3. Age ≥ 20 years
4. Patients who have not been taking any oral hypoglycemic agent for more than 12 weeks with HbA1c 7.0 to 8.5% at screening test or who have been taking metformin monotherapy for at least 8 weeks with HbA1c 7 to 9% at screening test
5. Agreement with written informed consent
Exclusion Criteria:
1. Patients whose alcohol consumption \>210g/week for males and 140g/week for females
2. chronic B viral hepatitis, chronic C viral hepatitis, Type I diabetes, or secondary diabetes
3. having a history of acute or chronic metabolic acidosis including diabetic ketoacidosis
4. patients who have been taking other oral hypoglycemic agents except metformin or insulin within recent 8 weeks
5. who experienced hypersensitivity reaction against metformin or glitazone drugs
6. who has been treated with corticosteroids for at least 14 days within 2 month prior to Screening
7. having a history of lactic acidosis
8. having genetic predispositions such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
9. who are in condition of malnutrition, starvation, cachexia, severe infection, major trauma, hypopituitarism, or adrenal insufficiency
10. diagnosed with cancer within 2 years or having chemo or radiotherapy for cancer treatment
11. a history of drug abuse or chronic alcoholism
12. a history of heart failure (NYHA class III and IV) or uncontrolled arrhythmia
13. a history of acute cardiovascular or cerebrovascular disease within 12 weeks prior to Screening (unstable angina, myocardial infarction, transient ischemic attack, cerebral infarct, cerebral hemorrhage, coronary bypass, percutaneous coronary intervention)
14. Renal dysfunction: Serum creatinine greater than 1.5mg/dl for males and 1.4mg/dl for females.
15. Anemia less than 10.5g/dl for any reason
16. Pregnant women or nursing mothers
17. Fertile women who not practice contraception with appropriate methods
18. in treatment concomitant drug from other clinical trials within 4 weeks from enrollment
19. who did not agree with written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02285205
Study Brief:
Protocol Section:
NCT02285205