Acceptability of a Fixed Combination of Fenofibrate and Metformin
Information source: Solvay Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyslipidemia/Glucose Metabolism Disorder
Intervention: fenofibrate and metformin fixed combination (drug) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Quotation by Visual Numeric Rating Scale before and after 4-week treatment
Secondary outcome: Assessment of safety by reporting of Adverse Events
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Site 1, Nort sur Erdre, France
Site 2, Nantes, France
Site 4, Saint Herblain, France
Site 5, Le Temple de Bretagne, France
Site 7, Saint Aignan le Grand, France
Site 8, Nantes, France
Site 9, Nantes, France
Site 10, St Etienne de Montluc, France
Site 11, Sautron, France
Site 12, Thouars, France
Site 13, Parcay les Pins, France
Site 17, Segre, France
Site 20, Vihiers, France
Site 21, Baune, France
Site 23, Bachant, France
Site 24, Anzin, France
Site 25, Vieux Conde, France
Site 26, Quarouble, France
Site 27, Denain, France
Site 28, Denain, France
Site 29, Nantes, France
Site 30, Saint-Amand, France
Site 32, Bersee, France
Site 33, Thiant, France
Site 34, Briollay, France
Additional Information
Starting date: April 2005
Last updated: August 31, 2007
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