NCT Number: NCT00490178
Acceptability Study of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Type 2 Diabetes and Dyslipidemia
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
Looking for future studies?
Notify MeKey information
Conditions
Age range
20 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Site 3, Marseille, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Male or female patients aged from 20 to 80 years (at inclusion visit).
- 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.
- Dyslipidemia treated with 160 mg fenofibrate (or bioequivalent formulations) for a minimum of 3 months either alone or in combination with a statin.
- And having signed a written informed consent.-
Exclusion criteria
- 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)].
- TG > 500 mg/dL (> 5.65 mmol/L) on the last performed blood sample (within the last 3 months).
- 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).
- Pregnant or lactating women.
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Solvay Pharmaceuticals
Industry
Registry information
Official study 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
Important dates
- Study start
- 2007
- First posted
- Jun 22, 2007
- Registry last updated
- Sep 3, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets
NCT00442325
Arterial Occlusive Diseases, Arteriosclerosis
Ioannina, Greece
View Trial DetailsEstablish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST)
NCT00442845
Arterial Occlusive Diseases, Arteriosclerosis
Mississauga, Ontario, Cameroon
View Trial DetailsComparative Bioavailability - Gender Effect - Single and Multiple Ascending Dose Safety and Pharmacokinetic Study of GFT505
NCT01474161
Body Weight, Cardiovascular Diseases
Paris, France
View Trial DetailsCholine Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
NCT05365425
Arterial Occlusive Diseases, Arteriosclerosis
Seongnam-si, Gyeonggi-do, South Korea
View Trial Details