Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Type 2 Diabetes Dyslipidemia |
| Intervention | Drug: Fenofibrate Drug: Metformin Drug: Placebo |
| Phase | Phase 2/Phase 3 |
| Sponsor | Solvay Pharmaceuticals |
| Responsible Party | Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier | NCT00362765 |
| First Received | August 9, 2006 |
| Last Updated | August 12, 2008 |
| Last verified | August 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 9, 2006 |
|---|---|
| Last Updated Date | August 12, 2008 |
| Start Date | October 2006 |
| Estimated Primary Completion Date | July 2007 |
| Current Primary Outcome Measures | Endogenous Glucose Production (EGP) and Glucose Disposal Rate (GDR) by two-step hyperinsulinemic euglycemic clamp (HEC) [Time Frame: 16 weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Gluconeogenesis, Glycogenolysis, Skeletal muscle and liver fat content, Abdominal fat content, Body energy expenditure and respiratory quotient, Lipids and glycemic parameters [Time Frame: 16 weeks] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study |
|---|---|
| Official Title | Assessment of Insulin Sensitivity in Type 2 Diabetics Treated With Metformin, Fenofibrate and Their Combination. |
| Brief 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2/Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: Fenofibrate 160 mg Drug: Metformin 2000 mg Drug: Placebo Placebo |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 8 |
| Estimated Completion Date | July 2007 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - Patients with type 2 diabetes mellitus and dyslipidemia. Exclusion Criteria: - Type 1 diabetes. |
| Gender | Both |
| Ages | 40 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Finland, Ireland, Italy |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00362765 |
|---|---|
| Other Study ID Numbers | C LF23-0121 05 03 |
| Has Data Monitoring Committee | No |
| Information Provided By | Solvay Pharmaceuticals |
| Study Sponsor | Solvay Pharmaceuticals |
| Collaborators | Not Provided |
| Investigators | Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals |
| Verification Date | August 2008 |
Locations[ + expand ][ + ]
| Site 2 | Turku, Finland |
|---|---|
| Site 3 | Dublin, Ireland |
| Site 1 | Pisa, Italy |