Evaluate the Efficacy of Fenofibrate on Microalbuminuria

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators design this prospective, open-label, parallel, controlled study to investigate fenofibrate's effect on microalbuminuria reduction and serum creatinine on top of statin therapy in Chinese hypertriglyceridemic patients with type 2 diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Chao Yang Hospital
• Treatments: Fenofibrate

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