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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00490178
Date of registration:	21/06/2007
Prospective Registration:	No
Primary sponsor:	Solvay Pharmaceuticals
Public title:	Acceptability Study of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Type 2 Diabetes and Dyslipidemia
Scientific title:	An 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
Date of first enrolment:	March 2007
Target sample size:	29
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00490178
Study type:	Interventional
Study design:	Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase:	Phase 3

Countries of recruitment
France

Contacts

Name:	Global Clinical Director Solvay
Address:
Telephone:
Email:
Affiliation:	Solvay Pharmaceuticals

Key inclusion & exclusion 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.

Age minimum: 20 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Dyslipidemia

Intervention(s)

Drug: Fenofibrate 80 mg and metformin 1000 mg (fixed combination)

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

2006-002848-28

C LF23-0121 06 02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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