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CompletedNCT00349128Updated Sep 3, 2007

Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

A Phase 2/3 interventional study of fenofibrate and metformin combination (drug) in Dyslipidemia/Glucose Metabolism Disorder, sponsored by Solvay Pharmaceuticals. Completed at 51 sites in 3 countries. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2007-09-03.

Sponsored by Solvay Pharmaceuticals · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
382
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

The primary objective was to assess the effect of 3-month treatment of low and standard doses of fenofibrate in combination with stable dose of metformin on fasting triglycerides levels 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 382 is above 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

  • Type 2 diabetes mellitus

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 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
382 participants

Interventions

  • Drugfenofibrate and metformin combination (drug)
06

What researchers measure

Primary outcomes

  1. Change in fasting triglycerides.

Secondary outcomes

  1. Assessment of lipid and glucose metabolisms.

07

Study locations

51 sites
  • Site 201
    Katowice, Poland
  • Site 203
    Katowice, Poland
  • Site 202
    Warszawa, Poland
  • Site 204
    Zabrze, Poland
  • Site 111
    Dnipropetrovsk, Ukraine
  • Site 113
    Dnipropetrovsk, Ukraine
  • Site 108
    Kharkiv, Ukraine
  • Site 109
    Kharkiv, Ukraine
  • Site 101
    Kyiv, Ukraine
  • Site 102
    Kyiv, Ukraine
  • Site 103
    Kyiv, Ukraine
  • Site 104
    Kyiv, Ukraine
  • Site 105
    Kyiv, Ukraine
  • Site 106
    Kyiv, Ukraine
  • Site 107
    Kyiv, Ukraine
  • Site 112
    Zaporizhya, Ukraine
  • Site 35
    Acomb, United Kingdom
  • Site 21
    Atherstone, United Kingdom
  • Site 14
    Balsall Common, United Kingdom
  • Site 32
    Bangor, United Kingdom
  • Site 23
    Barry, United Kingdom
  • Site 36
    Basingstoke, United Kingdom
  • Site 8
    Bexhill-on-Sea, United Kingdom
  • Site 20
    Camberley, United Kingdom
  • Site 22
    Chesterfield, United Kingdom
  • Site 10
    Chippenham, United Kingdom
  • Site 13
    Coventry, United Kingdom
  • Site 31
    Doncaster, United Kingdom
  • Site 15
    Downpatrick, United Kingdom
  • Site 17
    Ely, United Kingdom
  • Site 4
    Ely, United Kingdom
  • Site 11
    Fife, United Kingdom
  • Site 1
    Frome, United Kingdom
  • Site 16
    Harrow, United Kingdom
  • Site 5
    Hastings, United Kingdom
  • Site 26
    Haverfordwest, United Kingdom
  • Site 19
    Keresley end, United Kingdom
  • Site 9
    Kingswood, United Kingdom
  • Site 25
    Newtownabbey, United Kingdom
  • Site 33
    Northampton, United Kingdom
  • Site 28
    Odiham, United Kingdom
  • Site 3
    Paignton, United Kingdom
  • Site 12
    Petersborough, United Kingdom
  • Site 7
    Randalstown, United Kingdom
  • Site 27
    Slough, United Kingdom
  • Site 6
    Soham, United Kingdom
  • Site 2
    South Glamorgan, United Kingdom
  • Site 34
    Stratford on Avon, United Kingdom
  • Site 29
    Swindon, United Kingdom
  • Site 30
    Trowbridge, United Kingdom
  • Site 18
    Yaxley, United Kingdom
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
NCT00349128
Lead sponsor
Solvay Pharmaceuticals
First posted
Jul 6, 2006
Start date
Jan 2004
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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