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

Overview[ - collapse ][ - ]

Purpose 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
ConditionDiabetes Mellitus, Type 2
Dyslipidemia
InterventionDrug: Fenofibrate 80 mg and metformin 1000 mg (fixed combination)
PhasePhase 3
SponsorSolvay Pharmaceuticals
Responsible PartySolvay Pharmaceuticals
ClinicalTrials.gov IdentifierNCT00490178
First ReceivedJune 21, 2007
Last UpdatedAugust 31, 2007
Last verifiedAugust 2007

Tracking Information[ + expand ][ + ]

First Received DateJune 21, 2007
Last Updated DateAugust 31, 2007
Start DateMarch 2007
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresNot Provided
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleAcceptability Study of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Type 2 Diabetes and Dyslipidemia
Official TitleAn Open Label, Multicenter Trial Assessing the Acceptability of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Patients With Type 2 Diabetes and Dyslipidemia
Brief Summary
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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Diabetes Mellitus, Type 2
  • Dyslipidemia
InterventionDrug: Fenofibrate 80 mg and metformin 1000 mg (fixed combination)
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment29
Estimated Completion DateNot Provided
Estimated Primary Completion DateNot Provided
Eligibility Criteria
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.
GenderBoth
Ages20 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesFrance

Administrative Information[ + expand ][ + ]

NCT Number NCT00490178
Other Study ID NumbersC LF23-0121 06 02
Has Data Monitoring CommitteeNo
Information Provided BySolvay Pharmaceuticals
Study SponsorSolvay Pharmaceuticals
CollaboratorsNot Provided
Investigators Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Verification DateAugust 2007

Locations[ + expand ][ + ]

Site 3
Marseille, France
Site 1
Nantes, France
Site 2
Tours, France