Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study

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

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00362765

Enrollment

Registered

2006-08-10

Start date

2006-10-31

Completion date

2007-07-31

Last updated

2008-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Type 2 Diabetes

Keywords

Type 2 Diabetes, Dyslipidemia, Hyperinsulinemic, Clamp, Metformin, Fenofibrate

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.

Interventions

DRUGFenofibrate

160 mg

DRUGMetformin

2000 mg

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion criteria

* Type 1 diabetes.

Design outcomes

Primary

Measure	Time frame
Endogenous Glucose Production (EGP) and Glucose Disposal Rate (GDR) by two-step hyperinsulinemic euglycemic clamp (HEC)	16 weeks

Secondary

Measure	Time frame
Gluconeogenesis, Glycogenolysis, Skeletal muscle and liver fat content, Abdominal fat content, Body energy expenditure and respiratory quotient, Lipids and glycemic parameters	16 weeks

Countries

Finland, Ireland, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026