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CompletedNCT00348725Updated Sep 3, 2007

Acceptability of a Fixed Combination of Fenofibrate and Metformin

A Phase 3 interventional study of fenofibrate and metformin fixed combination (drug) in Dyslipidemia/Glucose Metabolism Disorder, sponsored by Solvay Pharmaceuticals. Completed at 25 sites in France. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2007-09-03.

Sponsored by Solvay Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
69
Allocation
Non-randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dyslipidemia/Glucose Metabolism Disorder

Keywords

  • Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's enrollment of 69 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Solvay Pharmaceuticals is the lead sponsor of 84 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion criteria

Exclusion Criteria:

  • Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c ≥ 10 % - Fasting plasma glucose > 300 mg/dL - Triglycerides > 500 mg/dL
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
69 participants

Interventions

  • Drugfenofibrate and metformin fixed combination (drug)
06

What researchers measure

Primary outcomes

  1. Quotation by Visual Numeric Rating Scale before and after 4-week treatment

Secondary outcomes

  1. Assessment of safety by reporting of Adverse Events

07

Study locations

25 sites
  • Site 24
    Anzin, France
  • Site 23
    Bachant, France
  • Site 21
    Baune, France
  • Site 32
    Bersee, France
  • Site 34
    Briollay, France
  • Site 27
    Denain, France
  • Site 28
    Denain, France
  • Site 5
    Le Temple de Bretagne, France
  • Site 29
    Nantes, France
  • Site 2
    Nantes, France
  • Site 8
    Nantes, France
  • Site 9
    Nantes, France
  • Site 1
    Nort sur Erdre, France
  • Site 13
    Parcay les Pins, France
  • Site 26
    Quarouble, France
  • Site 7
    Saint Aignan le Grand, France
  • Site 4
    Saint Herblain, France
  • Site 30
    Saint-Amand, France
  • Site 11
    Sautron, France
  • Site 17
    Segre, France
  • Site 10
    St Etienne de Montluc, France
  • Site 33
    Thiant, France
  • Site 12
    Thouars, France
  • Site 25
    Vieux Conde, France
  • Site 20
    Vihiers, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00348725
Lead sponsor
Solvay Pharmaceuticals
First posted
Jul 6, 2006
Start date
Apr 2005
Last update
Sep 3, 2007

Study contacts

Global Clinical Director Solvay
study director · Solvay Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.

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