A one-year multicentre, international, randomised, double-blind study with comparison of benfluorex versus an oral anti-diabetic in combination with sulfonylurea administered orally for the treatment of type two diabetes

Not Applicable

Completed

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN27354239
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22723853

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-11
• Study Completion: 2008-02-01
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 847

Inclusion Criteria

1. Male or female aged between 35 and 80 years
2. Body mass index (BMI) between 25 and 45 kg/m2
3. Treated in monotherapy with sulfonylurea
4. Presenting type 2 diabetes

Exclusion Criteria

1. Type 1 diabetes
2. Known latent autoimmune diabetes in adults

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evolution of HbA1c over one year of treatment.

Secondary Outcome Measures

Name	Time	Method
Other efficacy and safety criteria.