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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT02314533
Eligibility Criteria:
Inclusion Criteria:
* Females or males, and aged 20 to 65 years.
* Type 2 diabetes with microalbuminuria (Urinary albumin /creatinine ratio, ACR, between 30 and 300 mg/g, a first morning spot urine sample will be used to approximate the 24-hour urine albumin excretion) in two consecutive laboratory tests before the study period.
* At least 2 months statin monotherapy with low to moderate dose (atorvastatin ≤20mg q.d. or rosuvastatin≤10mg q.d. or simvastatin≤40mg q.d. or pravastatin≤40mg q.d.or pitavastatin≤2mg q.d or fluvastatin≤80mg q.d.or lovastatin≤40mg q.d) prior to enrollemnt and plan to continue the same type and dose of statin.
* TG≥1.7 mmol/L (150mg/dl) and TG\<5.65 mmol/L (500mg/dl).
* HbA1C\<8% and blood pressure\<140/90mmHg.
Exclusion Criteria:
* Any contraindication of fenofibrate and statins in Chinese label.
* Hepatic insufficiency (ALT or AST\> 1.5\*ULN)
* Renal insufficiency \[Creatinine clearance rate (Ccr)\]\<60ml/min estimated from MDRD equation)
* CK \> 1.5\*ULN
* Hypothyroidism
* Use of non-statin lipid-regulating drugs such as niacin and fish oil in previous 1 month
* Combination use of other fibrates or drug with similar structure, especially ketoprofen
* Combination use of oral anticoagulants
* Pregnant or lactating woman
* Other conditions at investigator's discretion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT02314533
Study Brief:
Protocol Section:
NCT02314533