Comparison of safety and efficacy of vildagliptin versus NPH insulin add-on to glimepiride in patients with type 2 diabetes mellitus

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-001143-46

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Extrait

1. To demonstrate that add-on to glimeperide vildagliptin is superior to NPH insulin with respect to the incidence of the combined endpoint, defined as a blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events (BG measurement < 3.9mM (71mg/dL)) and weight gain (+3%) in T2DM patients. 2. To demonstrate that add-on to glimepiride vildagliptin is superior to NPH insulin with respect to the rate of of confirmed hypoglycemic events (BG measurement < 3.9mM (71mg/dL)) in T2DM patients.


Critère d'inclusion

  • type-2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy

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