Completed
PHASE2
INTERVENTIONAL
NCT00703755
A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of Fenofibrate, Metformin, Their Combination and Placebo in Patients With Metabolic Syndrome.
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of this study was to study the effect of different combinations of fenofibrate and metformin on the cluster of metabolic syndrome (MetS) biochemical abnormalities, and to determine the dose combination allowing normalization of MetS patients.
Interventions
Name:
Fenofibrate /Metformin
Type:
DRUG
Description:
fenofibrate 2 x 40 mg bid + metformin 850 mg bid (F160-M1700)
Name:
Fenofibrate /Metformin
Type:
DRUG
Description:
fenofibrate 2 x 40 mg bid + metformin 500 mg bid (F160-M1000)
Name:
Fenofibrate /Metformin
Type:
DRUG
Description:
fenofibrate 40 mg bid + metformin 850 mg bid (F80-M1700)
Name:
Fenofibrate /Metformin
Type:
DRUG
Description:
fenofibrate 40 mg bid + metformin 500 mg bid (F80-M1000)
Name:
Fenofibrate /Metformin
Type:
DRUG
Description:
fenofibrate 2 x 40 mg bid + metformin placebo (F160-M0)
Name:
Fenofibrate /Metformin
Type:
DRUG
Description:
fenofibrate placebo + metformin 850 mg bid (F0-M1700)
Name:
Placebo
Type:
DRUG
Description:
Placebo
Primary Outcomes
Measure:
The percentage of normalized patients at V4 (fasting glucose < 6.1 mmol/L, TG < 1.69 mmol/L and HDL-C >= 1.03 mmol/L in males and >= 1.29 mmol/L in females)
TimeFrame:
End of study visit (V4)
Description:
Trial Information
NCT ID
NCT00703755
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Solvay Pharmaceuticals
Last Updated
December 15, 2025