drugset
drugset / Trial / NCT00362323

Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

NCT00362323 ↗

Phase 3 Completed 482 enrolled Solvay Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

To demonstrate in patients with T2DM and dyslipidemia not appropriately controlled with a statin and receiving metformin, the superiority of a fixed combination of fenofibrate and metformin vs metformin alone on TG and additionally, if the superiority on TG is established, to demonstrate the superiority on HDL-C

Timeline

Start
2006-10
Primary completion
2008-08
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Fenofibrate Small molecule 54 mg Oral
Subject Fenofibrate Small molecule 80 mg Oral
Comparator Metformin Small molecule 500 mg Oral
Comparator Metformin Small molecule 850 mg Oral

Indications

hyperlipidemia