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Acceptability Study of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Type 2 Diabetes and Dyslipidemia

NCT ID: NCT00490178

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

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Dyslipidemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Fenofibrate 80 mg and metformin 1000 mg (fixed combination)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female patients aged from 20 to 80 years (at inclusion visit).
2. 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.
3. Dyslipidemia treated with 160 mg fenofibrate (or bioequivalent formulations) for a minimum of 3 months either alone or in combination with a statin.
4. And having signed a written informed consent.-

Exclusion Criteria

1. Known Type 1 Diabetes, uncontrolled type 2 diabetes \[HbA1c \> 9.5 %, Fasting plasma glucose (FPG) \> 240 mg/dL (\> 13.4 mmol/L) on the last performed blood sample (within the last 3 months)\].
2. TG \> 500 mg/dL (\> 5.65 mmol/L) on the last performed blood sample (within the last 3 months).
3. 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).
4. Pregnant or lactating women.
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 3

Marseille, , France

Site Status

Site 1

Nantes, , France

Site Status

Site 2

Tours, , France

Site Status

Countries

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France

Other Identifiers

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2006-002848-28

Identifier Type: -

Identifier Source: secondary_id

C LF23-0121 06 02

Identifier Type: -

Identifier Source: org_study_id