NCT00348725

Brief Summary

The primary objective was to assess the acceptability of a 4-week treatment of 4 new fixed-dose combinations of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

25 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2006

Completed
Last Updated

September 3, 2007

Status Verified

August 1, 2007

First QC Date

July 5, 2006

Last Update Submit

August 31, 2007

Conditions

Dyslipidemia/Glucose Metabolism Disorder

Keywords

Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Quotation by Visual Numeric Rating Scale before and after 4-week treatment

Secondary Outcomes (1)

  • Assessment of safety by reporting of Adverse Events

Interventions

fenofibrate and metformin fixed combination (drug)DRUG

Eligibility Criteria

Age20 Years - 80 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, uncontrolled type 2 diabetes, - HbA1c ≥ 10 % - Fasting plasma glucose \> 300 mg/dL - Triglycerides \> 500 mg/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Site 24

Anzin, France

Location

Site 23

Bachant, France

Location

Site 21

Bauné, France

Location

Site 32

Bersée, France

Location

Site 34

Briollay, France

Location

Site 27

Denain, France

Location

Site 28

Denain, France

Location

Site 5

Le Temple-de-Bretagne, France

Location

Site 29

Nantes, France

Location

Site 2

Nantes, France

Location

Site 8

Nantes, France

Location

Site 9

Nantes, France

Location

Site 1

Nort-sur-Erdre, France

Location

Site 13

Parçay-les-Pins, France

Location

Site 26

Quarouble, France

Location

Site 7

Saint Aignan Le Grand, France

Location

Site 30

Saint-Amand, France

Location

Site 10

Saint-Étienne-de-Montluc, France

Location

Site 4

Saint-Herblain, France

Location

Site 11

Sautron, France

Location

Site 17

Segré, France

Location

Site 33

Thiant, France

Location

Site 12

Thouars, France

Location

Site 25

Vieux-Condé, France

Location

Site 20

Vihiers, France

Location

MeSH Terms

Conditions

DyslipidemiasGlucose Metabolism Disorders

Interventions

FenofibratePharmaceutical Preparations

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 6, 2006

Study Start

April 1, 2005

Last Updated

September 3, 2007

Record last verified: 2007-08

Locations

FR(25)