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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT01935167
Eligibility Criteria:
Inclusion Criteria:
* Has confirmed diabetic mellitus prior to 6years
* Has confirmed microalbuminuria 30 \~ 299㎍/㎎creatinine prior to 5months one time and microalbuminuria 30 \~ 299㎍/㎎creatinine during screening period
* Blood Pressure(BP) ≤ 150 / 90 mmHg
* estimated glomerular filtration rate(eGFR) ≥ 30 ml/min/1.73m2
* Hemoglobin A1c(HbA1c) ≤ 9%
* Low density lipoprotein(LDL-C) ≤ 130mg/dl
Exclusion Criteria:
* kidney or liver disease as follows i.Serum Creatinine \> 2.0mg/dl ii.Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) \> 2 x Upper Limit Normal(ULN) iii.Total Bilirubin \> 2 x ULN
* Organic gastrointestinal disorder or Chronic gastroenterologic disorders prior to 6 months as follows \[NOTE\] Active Crohn's disease, Active ulcerative colitis, Chronic peptic ulcer disease, etc.
* cardiovascular disease prior to 3 months as follows \[NOTE\] Unstable angina pectoris, Myocardial infarction, Coronary artery bypass surgery, Percutaneous Transluminal Coronary Angioplasty, transient ischemic attack, cerebrovascular accident etc.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT01935167
Study Brief:
Protocol Section:
NCT01935167