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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-004798-60-DE
Enrollment
840
Registered
2006-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2012-04-24

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

Conditions

Type II Diabetes MedDRA version: 7.0 Level: PT Classification code 10012613

Interventions

Product Name: S00780 Product Code: S00780 Pharmaceutical Form: Coated tablet INN or Proposed INN: benfluorex CAS Number: 23602-78-0 Current Sponsor code: S00780 Concentration unit: mg milligram(s) Con

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Male or female aged >=35 years and == 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 F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Main Objective: Compare the efficacy of benfluorex and pioglitazone in type 2 diabetic patients on top of sulfonylurea over one year of treatment.;Secondary Objective: Demonstrate the superiority of benfluorex combined with sulfonylurea compared to pioglitazone combined with sulfonylurea on cholesterol level. ;Primary end point(s): HbA1c.—

Countries

Czech Republic, Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026