NCT00362323

Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

A Randomized, Double-blind Study Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Metformin Alone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia Not Appropriately Controlled With a Statin.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 482 (actual)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Dyslipidemia/Glucose Metabolism Disorder

Interventions

Type	Name	Description
DRUG	fenofibrate (F) + metformin (M) hydrochloride fixed combination	F80mg/M500mg - per os - twice a day during 24 weeks / or / F80mg/M850mg - per os - twice a day during 24 weeks /or / F54mg/M850mg - per os - three times a day during 24 weeks
DRUG	Metformin	500mg - per os - twice a day during 24 weeks /or / 850mg - per os - twice a day during 24 weeks /or / 850mg - per os - three times a day during 24 weeks

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-08-01
• Completion: 2009-03-01
• First posted: 2006-08-10
• Last updated: 2010-04-16

Locations

70 sites across 7 countries: Czechia, France, Hungary, India, Lithuania, Poland, Slovakia