Acceptability of a Fixed Combination of Fenofibrate and Metformin

Dyslipidemia/Glucose Metabolism Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348725
• Other study ID #: C LF23-0121 04 02
• Status: Completed
• Phase: Phase 3
• First received: July 5, 2006
• Last updated: August 31, 2007
• Start date: April 2005

Study information

• Verified date: August 2007
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia/Glucose Metabolism Disorder
• Dyslipidemias
• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Drug:
• fenofibrate and metformin fixed combination (drug)

Locations

Country	Name	City	State
France	Site 24	Anzin
France	Site 23	Bachant
France	Site 21	Baune
France	Site 32	Bersee
France	Site 34	Briollay
France	Site 27	Denain
France	Site 28	Denain
France	Site 5	Le Temple de Bretagne
France	Site 2	Nantes
France	Site 29	Nantes
France	Site 8	Nantes
France	Site 9	Nantes
France	Site 1	Nort sur Erdre
France	Site 13	Parcay les Pins
France	Site 26	Quarouble
France	Site 7	Saint Aignan le Grand
France	Site 4	Saint Herblain
France	Site 30	Saint-Amand
France	Site 11	Sautron
France	Site 17	Segre
France	Site 10	St Etienne de Montluc
France	Site 33	Thiant
France	Site 12	Thouars
France	Site 25	Vieux Conde
France	Site 20	Vihiers

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quotation by Visual Numeric Rating Scale before and after 4-week treatment
Secondary	Assessment of safety by reporting of Adverse Events