NCT00362765

Brief Summary

Double-blind, randomized placebo-controlled study in type 2 diabetes and dyslipidemic patients.Patients will be randomized to one of four treatment arms for 16 weeks: placebo, fenofibrate, metformin, or metformin and fenofibrate combination.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2 type-2-diabetes

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2 type-2-diabetes

Geographic Reach
3 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

August 13, 2008

Status Verified

August 1, 2008

First QC Date

August 9, 2006

Last Update Submit

August 12, 2008

Conditions

Type 2 DiabetesDyslipidemia

Keywords

Type 2 DiabetesDyslipidemiaHyperinsulinemicClampMetforminFenofibrate

Outcome Measures

Primary Outcomes (1)

  • Endogenous Glucose Production (EGP) and Glucose Disposal Rate (GDR) by two-step hyperinsulinemic euglycemic clamp (HEC)

    16 weeks

Secondary Outcomes (1)

  • Gluconeogenesis, Glycogenolysis, Skeletal muscle and liver fat content, Abdominal fat content, Body energy expenditure and respiratory quotient, Lipids and glycemic parameters

    16 weeks

Study Arms (4)

1

EXPERIMENTAL
Drug: FenofibrateDrug: Metformin

2

ACTIVE COMPARATOR
Drug: Fenofibrate

3

ACTIVE COMPARATOR
Drug: Metformin

4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

FenofibrateDRUG

160 mg

12
MetforminDRUG

2000 mg

13
PlaceboDRUG

Placebo

4

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 2 diabetes mellitus and dyslipidemia.

You may not qualify if:

  • Type 1 diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Site 2

Turku, Finland

Location

Site 3

Dublin, Ireland

Location

Site 1

Pisa, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Dyslipidemias

Interventions

FenofibrateMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetonesBiguanidesGuanidinesAmidines

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 9, 2006

First Posted

August 10, 2006

Study Start

October 1, 2006

Study Completion

July 1, 2007

Last Updated

August 13, 2008

Record last verified: 2008-08

Locations

FI(1)IE(1)IT(1)