Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study
Information source: Solvay Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes; Dyslipidemia
Intervention: Fenofibrate (Drug); Metformin (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Terminated
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s): Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
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.
Clinical Details
Official title: Assessment of Insulin Sensitivity in Type 2 Diabetics Treated With Metformin, Fenofibrate and Their Combination.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Endogenous Glucose Production (EGP) and Glucose Disposal Rate (GDR) by two-step hyperinsulinemic euglycemic clamp (HEC)
Secondary outcome: Gluconeogenesis, Glycogenolysis, Skeletal muscle and liver fat content, Abdominal fat content, Body energy expenditure and respiratory quotient, Lipids and glycemic parameters
Eligibility
Minimum age: 40 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with type 2 diabetes mellitus and dyslipidemia.
Exclusion Criteria:
- Type 1 diabetes.
Locations and Contacts
Site 2, Turku, Finland
Site 3, Dublin, Ireland
Site 1, Pisa, Italy
Additional Information
Starting date: October 2006
Last updated: August 12, 2008
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