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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Efficacy of benfluorex in combination with sulfonylurea in type 2 diabetic patients: An 18 to 34-week, open-label, extension period
Diabetes and Metabolism, Volume 35, No. 1, Year 2009
Notification
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Description
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 HbA1c, 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, HbA1c 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 HbA1c (≤ 7%) was achieved in 36% (103 of 289) of patients and a decrease in HbA1c 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 HbA1c 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.
Authors & Co-Authors
Moulin, Philippe
France, Villeurbanne
Université Claude Bernard Lyon 1
André, Marie
France, Neuilly-sur-seine
Servier
Alawi, Hasan
Germany, Bad Oeynhausen
Herz- Und Diabeteszentrum Nordrhein-westfalen Universitätsklinik Der Ruhr-universität Bochum
Santos, Lélita Conceição
Portugal, Coimbra
Centro Hospitalar e Universitário de Coimbra
Khalid, Abdul K.
Malaysia, Bangi
Universiti Kebangsaan Malaysia
Koev, Dragomir
Bulgaria, Sofia
Sofia University St. Kliment Ohridski
Moore, Ray
South Africa, Durban
Umhlanga Hospital
Şerban, Viorel
Timisoara
Spitalul Judetean
Picandet, Brigitte
France, Neuilly-sur-seine
Servier
Francillard, Marie
France, Neuilly-sur-seine
Servier
Statistics
Citations: 10
Authors: 10
Affiliations: 8
Identifiers
Doi:
10.1016/j.diabet.2008.10.002
ISSN:
12623636
Research Areas
Disability
Infectious Diseases
Study Design
Cohort Study