Back to resultsAcceptability of a Fixed Combination of Fenofibrate and Metformin
Primary Purpose
Dyslipidemia/Glucose Metabolism Disorder
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
fenofibrate and metformin fixed combination (drug)
Sponsored by
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
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
Sites / Locations
- Site 24
- Site 23
- Site 21
- Site 32
- Site 34
- Site 27
- Site 28
- Site 5
- Site 29
- Site 2
- Site 8
- Site 9
- Site 1
- Site 13
- Site 26
- Site 7
- Site 4
- Site 30
- Site 11
- Site 17
- Site 10
- Site 33
- Site 12
- Site 25
- Site 20
Outcomes
Primary Outcome Measures
Quotation by Visual Numeric Rating Scale before and after 4-week treatment
Secondary Outcome Measures
Assessment of safety by reporting of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00348725
Brief Title
Acceptability of a Fixed Combination of Fenofibrate and Metformin
Official Title
An Open Label, Parallel-Arm, Multicenter Trial Assessing the Acceptability of 4 Dosages of a New Fixed Dose Combination of Fenofibrate and Metformin 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
April 2005 (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 acceptability of a 4-week treatment of 4 new fixed-dose combinations of fenofibrate and metformin, 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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
fenofibrate and metformin fixed combination (drug)
Primary Outcome Measure Information:
Title
Quotation by Visual Numeric Rating Scale before and after 4-week treatment
Secondary Outcome Measure Information:
Title
Assessment of safety by reporting of Adverse Events
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:
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
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 24
City
Anzin
Country
France
Facility Name
Site 23
City
Bachant
Country
France
Facility Name
Site 21
City
Baune
Country
France
Facility Name
Site 32
City
Bersee
Country
France
Facility Name
Site 34
City
Briollay
Country
France
Facility Name
Site 27
City
Denain
Country
France
Facility Name
Site 28
City
Denain
Country
France
Facility Name
Site 5
City
Le Temple de Bretagne
Country
France
Facility Name
Site 29
City
Nantes
Country
France
Facility Name
Site 2
City
Nantes
Country
France
Facility Name
Site 8
City
Nantes
Country
France
Facility Name
Site 9
City
Nantes
Country
France
Facility Name
Site 1
City
Nort sur Erdre
Country
France
Facility Name
Site 13
City
Parcay les Pins
Country
France
Facility Name
Site 26
City
Quarouble
Country
France
Facility Name
Site 7
City
Saint Aignan le Grand
Country
France
Facility Name
Site 4
City
Saint Herblain
Country
France
Facility Name
Site 30
City
Saint-Amand
Country
France
Facility Name
Site 11
City
Sautron
Country
France
Facility Name
Site 17
City
Segre
Country
France
Facility Name
Site 10
City
St Etienne de Montluc
Country
France
Facility Name
Site 33
City
Thiant
Country
France
Facility Name
Site 12
City
Thouars
Country
France
Facility Name
Site 25
City
Vieux Conde
Country
France
Facility Name
Site 20
City
Vihiers
Country
France
12. IPD Sharing Statement
Learn more about this trial
Acceptability of a Fixed Combination of Fenofibrate and Metformin
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