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.

• Conditions: Type II Diabetes; MedDRA version: 7.0Level: PTClassification code 10012613

• Registration Number: EUCTR2005-004798-60-CZ
• Lead Sponsor: I.R.I.S. Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-18
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 840

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
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>;Primary end point(s): HbA1c.