Diabetes & Metabolism 35 (2009) 64–70 Original article Efficacy of benfluorex in combination with sulfonylurea in type 2 diabetic patients: An 18 to 34-week, open-label, extension period P. Moulin a,∗ , M. André b , H. Alawi c , L.C. Dos Santos d , A.K. Khalid e , D. Koev f , R. Moore g , V. Serban h , B. Picandet b , M. Francillard b a Service d’endocrinologie – unité 11, hôpital cardiovasculaire Louis-Pradel, hospices civils de Lyon, université Lyon-1, 28, avenue Doyen-Lepine, 69677 Bron cedex, France b Institut de recherches internationales Servier, Courbevoie, France c Diabetes Center, Saarlouis, Germany d University Hospital of Coimbra, Coimbra, Portugal e University Kebangsaan, Kuala Lumpur, Malaysia f University of Sofia, Sofia, Bulgaria g Umhlanga Hospital, Durban, South Africa h Spitalul Judetean, Timisoara, Romania Received 18 July 2008; received in revised form 9 October 2008; accepted 14 October 2008 Available online 15 January 2009 Abstract Aim. – The aim of this trial was to obtain further data on the efficacy and safety of benfluorex as an add-on therapy in type 2 diabetic patients insufficiently controlled by sulfonylurea monotherapy who had a limitation for the use of metformin during a 4-month extension period following a 4-month double-blind trial. Methods. – Patients who completed the 18-week double-blind period entered the 16-week extension period. Patients in the benfluorex group during the double-blind period continued benfluorex 450 mg/day (B-B group), whilst patients in the placebo group switched to benfluorex 450 mg/day (P-B group). The main efficacy criterion was HbA 1c , analyzed as the change from week 18 (W18) to the end of treatment using a two-sided Student paired t-test. Secondary criteria were fasting plasma glucose (FPG), insulin resistance and lipids. Results. – Between W18 and the end of treatment, HbA 1c decreased in the P-B group from 8.53 ± 1.37% to 7.49 ± 1.04% (P < 0.001) and remained stable in the B-B group from 7.52 ± 1.07% to 7.53 ± 1.14% (NS). In the P-B group, parameters of glycemic control showed improvements from W18 to week 34 (W34) which were similar to those observed from baseline to W18 in the B-B group. Overall, the target HbA 1c (≤ 7%) was achieved in 36% (103 of 289) of patients and a decrease in HbA 1c of at least 1% was seen in 44% (128 of 289) of patients. Digestive disorders were the most common adverse events and the incidence of diarrhoea was 4.9% in patients receiving benfluorex for 34 weeks. Conclusion. – The beneficial effect of benfluorex as add-on therapy in lowering HbA 1c at W18 was maintained at W34 without evidence for a loss of efficacy or an increased incidence of side effects over a 34-week follow-up. © 2008 Elsevier Masson SAS. All rights reserved. Résumé Efficacité de l’association du benfluorex aux sulfamides hypoglycémiants chez des diabétiques de type 2 : période d’extension 18 à 34 semaines, en ouvert. Objectif. – L’objectif de cette étude était de disposer de données supplémentaires sur l’efficacité et la tolérance de benfluorex en association à un sulfamide hypoglycémiant chez des patients imparfaitement contrôlés en monothérapie par sulfamide hypoglycémiant et intolérants ou présentant une contre-indication à la metformine, au cours d’une période de quatre mois faisant suite à une période de quatre mois en double-insu. Méthodes. – Les patients ayant terminé la période en double-insu ont été inclus dans la période d’extension. Les patients sous benfluorex pendant la période double-insu continuaient de recevoir benfluorex 450 mg/j (groupe B-B) alors que ceux qui étaient préalablement sous placebo recevaient benfluorex 450 mg/j (groupe P-B). Le critère principal d’efficacité était la variation de l’HbA 1c de la semaine 18 à la fin du traitement et était analysé selon un test t de Student bilatéral. Les critères secondaires étaient la glycémie à jeun, l’insulinorésistance et les lipides plasmatiques. ∗ Corresponding author. E-mail address: philippe.moulin@chu-lyon.fr (P. Moulin). 1262-3636/$ – see front matter © 2008 Elsevier Masson SAS. All rights reserved. doi:10.1016/j.diabet.2008.10.002