Acceptability of a Fixed Combination of Fenofibrate and Metformin

NCT ID: NCT00348725

Last Updated: 2007-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dyslipidemia/Glucose Metabolism Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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fenofibrate and metformin fixed combination (drug)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion Criteria

* Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c ≥ 10 % - Fasting plasma glucose \> 300 mg/dL - Triglycerides \> 500 mg/dL
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 24

Anzin, , France

Site Status

Site 23

Bachant, , France

Site Status

Site 21

Bauné, , France

Site Status

Site 32

Bersée, , France

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Site 34

Briollay, , France

Site Status

Site 27

Denain, , France

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Site 28

Denain, , France

Site Status

Site 5

Le Temple-de-Bretagne, , France

Site Status

Site 29

Nantes, , France

Site Status

Site 2

Nantes, , France

Site Status

Site 8

Nantes, , France

Site Status

Site 9

Nantes, , France

Site Status

Site 1

Nort-sur-Erdre, , France

Site Status

Site 13

Parçay-les-Pins, , France

Site Status

Site 26

Quarouble, , France

Site Status

Site 7

Saint Aignan Le Grand, , France

Site Status

Site 30

Saint-Amand, , France

Site Status

Site 10

Saint-Étienne-de-Montluc, , France

Site Status

Site 4

Saint-Herblain, , France

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Site 11

Sautron, , France

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Site 17

Segré, , France

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Site 33

Thiant, , France

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Site 12

Thouars, , France

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Site 25

Vieux-Condé, , France

Site Status

Site 20

Vihiers, , France

Site Status

Countries

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France

Other Identifiers

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C LF23-0121 04 02

Identifier Type: -

Identifier Source: org_study_id