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Clinical Trials/EUCTR2005-004798-60-DE
EUCTR2005-004798-60-DE
Active, not recruiting
Not Applicable

A one-year multicentre, international, randomised, double-blind study with comparison of benfluorex (150 mg od to 150 mg tid) versus pioglitazone (30 mg od to 45 mg od) in combination with sulfonylurea administered orally for the treatment of type 2 diabetes.

I.R.I.S. Institut de Recherches Internationales Servier0 sites840 target enrollmentFebruary 3, 2006
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
I.R.I.S. Institut de Recherches Internationales Servier
Enrollment
840
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 3, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
I.R.I.S. Institut de Recherches Internationales Servier

Eligibility Criteria

Inclusion Criteria

  • •\- Male or female aged \>\=35 years and \=\< 80 years,
  • •\- BMI between 25 and 40 kg/m2 (inclusive),
  • •\- out\-patients with type 2 diabetes,
  • •\- in monotherapy with a sulfonylurea at stable dose for at least 3 consecutive months prior to the selection visit and at dose \>\= 50% of the maximal recommended one,
  • •\- HbA1c between 7% and 10% inclusive.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •\- Type 1 diabetes
  • •\- Known Latent Autoimmune Diabetes in Adults,
  • •\- Type 2 diabetes treated in the previous 3 months with an oral hypoglycaemic agent other than a sulfonylurea,
  • •\- Type 2 diabetes treated with more than 1 oral hypoglycaemic agent in the previous 3 months,
  • •\- Insulin treatment in the previous year, except short term treatment for exceptional reason such as surgery

Outcomes

Primary Outcomes

Not specified

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