Efficacy of benfluorex in combination with sulfonylurea in type 2 diabetic patients: An 18 to 34-week, open-label, extension period

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 450mg/day (B-B group), whilst patients in the placebo group switched to benfluorex 450mg/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 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.