NCT00490178

Brief Summary

The present study aims to assess the acceptability of a 4 week treatment of a new fixed-dose combination 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
29

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

March 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2007

Completed
Last Updated

September 3, 2007

Status Verified

August 1, 2007

First QC Date

June 21, 2007

Last Update Submit

August 31, 2007

Conditions

Diabetes Mellitus, Type 2Dyslipidemia

Keywords

Type II diabetesdyslipidemiametforminfenofibratesynordia

Interventions

Fenofibrate 80 mg and metformin 1000 mg (fixed combination)DRUG

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes treated with a stable dose of metformin for a minimum of 3 months either alone or in combination with another oral hypoglycaemic agent.
  • Dyslipidemia treated with 160 mg fenofibrate (or bioequivalent formulations) for a minimum of 3 months either alone or in combination with a statin.
  • And having signed a written informed consent.-

You may not qualify if:

  • Known Type 1 Diabetes, uncontrolled type 2 diabetes \[HbA1c \> 9.5 %, Fasting plasma glucose (FPG) \> 240 mg/dL (\> 13.4 mmol/L) on the last performed blood sample (within the last 3 months)\].
  • TG \> 500 mg/dL (\> 5.65 mmol/L) on the last performed blood sample (within the last 3 months).
  • Women who are not surgically sterilized (i.e. bilateral tubal ligation, bilateral or two unilateral oophorectomies, hysterectomy) or not using adequate contraceptive methods (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide) or not postmenopausal (\> 1 year since their last menstrual period).
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Site 3

Marseille, France

Location

Site 1

Nantes, France

Location

Site 2

Tours, France

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 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 21, 2007

First Posted

June 22, 2007

Study Start

March 1, 2007

Last Updated

September 3, 2007

Record last verified: 2007-08

Locations

FR(3)