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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00362323

Enrollment

482

Registered

2006-08-10

Start date

2006-10-31

Completion date

2009-03-31

Last updated

2010-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia/Glucose Metabolism Disorder

Keywords

Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus

Brief 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

Interventions

DRUGfenofibrate (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

DRUGMetformin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Patient with Type 2 Diabetes treated with stable dose of metformin and with dyslipidemia not appropriately controlled with a statin treatment.

Exclusion criteria

Type 1 diabetes.

Design outcomes

Primary

Measure	Time frame
TG / HDL-C ratio	24 weeks

Secondary

Measure	Time frame
Lipid and glycemic parameters	24 weeks

Countries

Czechia, France, Hungary, India, Lithuania, Poland, Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026