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Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

Primary Purpose

Dyslipidemia/Glucose Metabolism Disorder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
fenofibrate and metformin combination (drug)
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia/Glucose Metabolism Disorder focused on measuring Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Type 2 diabetes mellitus Exclusion Criteria: Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c ≥ 10 % - Fasting plasma glucose > 300 mg/dL - Triglycerides > 500 mg/dL

Sites / Locations

  • Site 201
  • Site 203
  • Site 202
  • Site 204
  • Site 111
  • Site 113
  • Site 108
  • Site 109
  • Site 101
  • Site 102
  • Site 103
  • Site 104
  • Site 105
  • Site 106
  • Site 107
  • Site 112
  • Site 35
  • Site 21
  • Site 14
  • Site 32
  • Site 23
  • Site 36
  • Site 8
  • Site 20
  • Site 22
  • Site 10
  • Site 13
  • Site 31
  • Site 15
  • Site 17
  • Site 4
  • Site 11
  • Site 1
  • Site 16
  • Site 5
  • Site 26
  • Site 19
  • Site 9
  • Site 25
  • Site 33
  • Site 28
  • Site 3
  • Site 12
  • Site 7
  • Site 27
  • Site 6
  • Site 2
  • Site 34
  • Site 29
  • Site 30
  • Site 18

Outcomes

Primary Outcome Measures

Change in fasting triglycerides.

Secondary Outcome Measures

Assessment of lipid and glucose metabolisms.

Full Information

First Posted
July 5, 2006
Last Updated
August 31, 2007
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00349128
Brief Title
Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes
Official Title
A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Low and Standard Doses of Fenofibrate in Combination With Metformin on the Lipid Profile in Patients With Type 2 Diabetes and Dyslipidemia.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The primary objective was to assess the effect of 3-month treatment of low and standard doses of fenofibrate in combination with stable dose of metformin on fasting triglycerides levels in patients with type 2 diabetes and dyslipidemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia/Glucose Metabolism Disorder
Keywords
Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
382 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fenofibrate and metformin combination (drug)
Primary Outcome Measure Information:
Title
Change in fasting triglycerides.
Secondary Outcome Measure Information:
Title
Assessment of lipid and glucose metabolisms.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes mellitus Exclusion Criteria: Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c ≥ 10 % - Fasting plasma glucose > 300 mg/dL - Triglycerides > 500 mg/dL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 201
City
Katowice
Country
Poland
Facility Name
Site 203
City
Katowice
Country
Poland
Facility Name
Site 202
City
Warszawa
Country
Poland
Facility Name
Site 204
City
Zabrze
Country
Poland
Facility Name
Site 111
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Site 113
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Site 108
City
Kharkiv
Country
Ukraine
Facility Name
Site 109
City
Kharkiv
Country
Ukraine
Facility Name
Site 101
City
Kyiv
Country
Ukraine
Facility Name
Site 102
City
Kyiv
Country
Ukraine
Facility Name
Site 103
City
Kyiv
Country
Ukraine
Facility Name
Site 104
City
Kyiv
Country
Ukraine
Facility Name
Site 105
City
Kyiv
Country
Ukraine
Facility Name
Site 106
City
Kyiv
Country
Ukraine
Facility Name
Site 107
City
Kyiv
Country
Ukraine
Facility Name
Site 112
City
Zaporizhya
Country
Ukraine
Facility Name
Site 35
City
Acomb
Country
United Kingdom
Facility Name
Site 21
City
Atherstone
Country
United Kingdom
Facility Name
Site 14
City
Balsall Common
Country
United Kingdom
Facility Name
Site 32
City
Bangor
Country
United Kingdom
Facility Name
Site 23
City
Barry
Country
United Kingdom
Facility Name
Site 36
City
Basingstoke
Country
United Kingdom
Facility Name
Site 8
City
Bexhill-on-Sea
Country
United Kingdom
Facility Name
Site 20
City
Camberley
Country
United Kingdom
Facility Name
Site 22
City
Chesterfield
Country
United Kingdom
Facility Name
Site 10
City
Chippenham
Country
United Kingdom
Facility Name
Site 13
City
Coventry
Country
United Kingdom
Facility Name
Site 31
City
Doncaster
Country
United Kingdom
Facility Name
Site 15
City
Downpatrick
Country
United Kingdom
Facility Name
Site 17
City
Ely
Country
United Kingdom
Facility Name
Site 4
City
Ely
Country
United Kingdom
Facility Name
Site 11
City
Fife
Country
United Kingdom
Facility Name
Site 1
City
Frome
Country
United Kingdom
Facility Name
Site 16
City
Harrow
Country
United Kingdom
Facility Name
Site 5
City
Hastings
Country
United Kingdom
Facility Name
Site 26
City
Haverfordwest
Country
United Kingdom
Facility Name
Site 19
City
Keresley end
Country
United Kingdom
Facility Name
Site 9
City
Kingswood
Country
United Kingdom
Facility Name
Site 25
City
Newtownabbey
Country
United Kingdom
Facility Name
Site 33
City
Northampton
Country
United Kingdom
Facility Name
Site 28
City
Odiham
Country
United Kingdom
Facility Name
Site 3
City
Paignton
Country
United Kingdom
Facility Name
Site 12
City
Petersborough
Country
United Kingdom
Facility Name
Site 7
City
Randalstown
Country
United Kingdom
Facility Name
Site 27
City
Slough
Country
United Kingdom
Facility Name
Site 6
City
Soham
Country
United Kingdom
Facility Name
Site 2
City
South Glamorgan
Country
United Kingdom
Facility Name
Site 34
City
Stratford on Avon
Country
United Kingdom
Facility Name
Site 29
City
Swindon
Country
United Kingdom
Facility Name
Site 30
City
Trowbridge
Country
United Kingdom
Facility Name
Site 18
City
Yaxley
Country
United Kingdom

12. IPD Sharing Statement

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Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

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