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Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study

Primary Purpose

Type 2 Diabetes, Dyslipidemia

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Fenofibrate
Metformin
Placebo
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Dyslipidemia, Hyperinsulinemic, Clamp, Metformin, Fenofibrate

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with type 2 diabetes mellitus and dyslipidemia. Exclusion Criteria: Type 1 diabetes.

Sites / Locations

  • Site 2
  • Site 3
  • Site 1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Endogenous Glucose Production (EGP) and Glucose Disposal Rate (GDR) by two-step hyperinsulinemic euglycemic clamp (HEC)

Secondary Outcome Measures

Gluconeogenesis, Glycogenolysis, Skeletal muscle and liver fat content, Abdominal fat content, Body energy expenditure and respiratory quotient, Lipids and glycemic parameters

Full Information

First Posted
August 9, 2006
Last Updated
August 12, 2008
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00362765
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Terminated
Why Stopped
The study was prematurely terminated, due to difficulties in the recruitment of T2DM patients who are not under statin therapy at inclusion.
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Dyslipidemia
Keywords
Type 2 Diabetes, Dyslipidemia, Hyperinsulinemic, Clamp, Metformin, Fenofibrate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Intervention Description
160 mg
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
2000 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Endogenous Glucose Production (EGP) and Glucose Disposal Rate (GDR) by two-step hyperinsulinemic euglycemic clamp (HEC)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with type 2 diabetes mellitus and dyslipidemia. Exclusion Criteria: Type 1 diabetes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 2
City
Turku
Country
Finland
Facility Name
Site 3
City
Dublin
Country
Ireland
Facility Name
Site 1
City
Pisa
Country
Italy

12. IPD Sharing Statement

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Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study

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