Acceptability of a Fixed Combination of Fenofibrate and Metformin

An Open Label, Parallel-Arm, Multicenter Trial Assessing the Acceptability of 4 Dosages of a New Fixed Dose Combination of Fenofibrate and Metformin in Patients With Type 2 Diabetes and Dyslipidemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00348725

Enrollment

Registered

2006-07-06

Start date

2005-04-30

Completion date

Unknown

Last updated

2007-09-03

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

Conditions

Dyslipidemia/Glucose Metabolism Disorder

Keywords

Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus

Brief summary

The primary objective was to assess the acceptability of a 4-week treatment of 4 new fixed-dose combinations of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia.

Interventions

DRUGfenofibrate and metformin fixed combination (drug)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion criteria

* Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c ≥ 10 % - Fasting plasma glucose \> 300 mg/dL - Triglycerides \> 500 mg/dL

Design outcomes

Primary

Measure	Time frame
Quotation by Visual Numeric Rating Scale before and after 4-week treatment	—

Secondary

Measure	Time frame
Assessment of safety by reporting of Adverse Events	—

Countries

France

Outcome results

None listed

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