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NCT00362765 Clinical Trial

Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study

Type 2 Diabetes Clinical Trial

Official title:
Assessment of Insulin Sensitivity in Type 2 Diabetics Treated With Metformin, Fenofibrate and Their Combination.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00362765
Other study ID # C LF23-0121 05 03
Secondary ID 2005-003347-31
Status Terminated
Phase Phase 2/Phase 3
First received August 9, 2006
Last updated August 12, 2008
Start date October 2006
Est. completion date July 2007

Study information
Verified date August 2008
Source Solvay Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Ireland: Irish Medicines BoardFinland: Finnish Medicines AgencyItaly: The Italian Medicines Agency
Study type Interventional

Clinical Trial Summary

Double-blind, randomized placebo-controlled study in type 2 diabetes and dyslipidemic patients.Patients will be randomized to one of four treatment arms for 16 weeks: placebo, fenofibrate, metformin, or metformin and fenofibrate combination.

Recruitment information / eligibility
Status Terminated
Enrollment 8
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion Criteria:

- Type 1 diabetes.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Fenofibrate
160 mg
• Metformin
2000 mg
• Placebo
Placebo

Locations
Country Name City State
Finland Site 2 Turku
Ireland Site 3 Dublin
Italy Site 1 Pisa

Sponsors (1)
Lead Sponsor Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

Finland,  Ireland,  Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Endogenous Glucose Production (EGP) and Glucose Disposal Rate (GDR) by two-step hyperinsulinemic euglycemic clamp (HEC) 16 weeks No
Secondary Gluconeogenesis, Glycogenolysis, Skeletal muscle and liver fat content, Abdominal fat content, Body energy expenditure and respiratory quotient, Lipids and glycemic parameters 16 weeks No
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