Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration for the Treatment of Hyperglycemia in Metformin Monotherapy Treated Type 2 Diabetic Patients: a Randomized, Double-...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-009889-13

Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration for the Treatment of Hyperglycemia in Metformin Monotherapy Treated Type 2 Diabetic Patients: a Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study

Femme et Homme

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Extrait

For Period II • To assess safety and tolerability of four doses of ACZ885 (5 mg, 15 mg, 50 mg, and 150 mg) vs. placebo as an add-on regimen over 4 months. • To assess the effect on HbA1c of four doses of ACZ885 (5 mg, 15 mg, 50 mg, and 150 mg) vs. placebo as an add-on regimen over 4 months. For Period III • To assess the anti-apoptotic effect of ACZ885 vs. placebo on the meal challenge derived dynamic phase secreted insulin per unit of glucose concentration in patients who have been on study drug anywhere from 6 months to 18 months. For Period IV • To assess the safety and tolerability of active treatment of ACZ885 vs. placebo, as an add-on regimen over a minimum of 24 months (up to 48 months) period.


Critère d'inclusion

  • type II diabetes mellitus