BEGIN™: EASY PM A trial comparing the efficacy and safety of NN1250 and insulin glargine in subjects with type 2 diabetes

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-011399-31

Femme et Homme

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Extrait

To confirm the efficacy of SIBA 200 U/ml three times weekly + metformin ± DPP-4 inhibitor in controlling glycaemia with respect to change from baseline in HbA1c after 26 weeks of treatment. This is done by comparing the difference in change from baseline in HbA1c after 26 weeks of treatment between SIBA 200 U/ml three times weekly + metformin ± DPP-4 inhibitor and insulin glargine once daily (OD) + metformin ± DPP-4 inhibitor 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 mellitus