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A 52-week randomised, controlled, open label, multicentre, multinational treat-to-target trial comparing the efficacy and safety of SIBA and insulin glargine, both injected once daily in combination w...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-005776-27

A 52-week randomised, controlled, open label, multicentre, multinational treat-to-target trial comparing the efficacy and safety of SIBA and insulin glargine, both injected once daily in combination with oral anti-diabetic drugs (OAD), in subjects with type 2 diabetes mellitus currently treated with OAD(s) and qualifying for more intensified treatment

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Extrait

To confirm the efficacy of SIBA + OAD(s) in controlling glycaemia with respect to change from baseline in HbA1c after 52 weeks of treatment. This is done by comparing the difference in change from baseline in HbA1c after 52 weeks of treatment between SIBA + OAD(s) and insulin glargine + OAD(s) to a non-inferiority limit of 0.4%, and if non-inferiority is confirmed, to a superiority limit of 0%.

Critère d'inclusion

  • Type 2 Diabetes

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