Femme et Homme
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Extrait
Background and study aims Gliclazide is a well-known drug prescribed to control glucose levels in patients with type 2 diabetes mellitus. Diamicron MR 60 mg is a new modified-release formulation of gliclazide that enables the number of tablets per intake to be halved and allows gradual increase of dosage up to an optimal level. This new formulation is also expected to enhance compliance, meaning that more patients take their treatment properly and have better control of their diabetes. The aim of the ongoing EasyDia program is to analyse how the new formulation Diamicron MR 60 mg is prescribed in daily clinical practice, notably of how rapidly and easily patients reach the optimal dosage. Who can participate? EasyDia is including over 5000 male or female patients aged 35 years or older with type 2 diabetes with glucose levels that are poorly controlled with diet or lifestyle measures or with other antidiabetic treatments (except insulin). What does the study involve? This is an observational study, which means that included patients are managed in exactly the same way as they would be if they were not participating in the program. What are the possible benefits and risks of participating? There should be no net benefit or risk for the participants as this is an observational study in which the participants will be treated as in normal practice. It should be noted that gliclazide has been in clinical use in other formulations since 40 years, and is not associated with any untoward safety issues. Where is the study run from? The study in taking place in 8 countries (Armenia, Russia, Switzerland, Malaysia, Georgia, The Lebanon, Slovenia, and Bangladesh) and all investigators are physicians in general practice or hospitals. When is the study starting and how long is it expected to run for? The first patient visit was in July 2011 and the study is expected to end in October 2013. Who is funding the study? The study is being funded by the French pharmaceutical company Servier. Who is the main contact? Manuel Ruiz [email protected]
Critère d'inclusion
- Type 2 diabetes mellitus