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Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study

NCT ID: NCT00362765

Last Updated: 2008-08-13

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

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Dyslipidemia

Keywords

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Type 2 Diabetes Dyslipidemia Hyperinsulinemic Clamp Metformin Fenofibrate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Fenofibrate

Intervention Type DRUG

160 mg

Metformin

Intervention Type DRUG

2000 mg

2

Group Type ACTIVE_COMPARATOR

Fenofibrate

Intervention Type DRUG

160 mg

3

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

2000 mg

4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Fenofibrate

160 mg

Intervention Type DRUG

Metformin

2000 mg

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion Criteria

* Type 1 diabetes.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Solvay Pharmaceuticals

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 2

Turku, , Finland

Site Status

Site 3

Dublin, , Ireland

Site Status

Site 1

Pisa, , Italy

Site Status

Countries

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Finland Ireland Italy

Other Identifiers

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2005-003347-31

Identifier Type: -

Identifier Source: secondary_id

C LF23-0121 05 03

Identifier Type: -

Identifier Source: org_study_id