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A multicenter, randomized, double-blind, parallel-group study to investigate the glucose lowering effect, safety and tolerability of a 24 week treatment with Vildagliptin 100 mg o.a.d. versus placebo ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-000538-37

A multicenter, randomized, double-blind, parallel-group study to investigate the glucose lowering effect, safety and tolerability of a 24 week treatment with Vildagliptin 100 mg o.a.d. versus placebo followed by a 12 week treatment period with open-label Vildagliptin 100 mg o.a.d. as add-on therapy in patients with type 2 diabetes inadequately controlled with Metformin monotherapy

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Extrait

To confirm the efficacy of vildagliptin 100 mg add-on therapy in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy by testing the hypothesis that the HbA1c reduction with vildagliptin 100 mg o.a.d. (hierarchically testing of pooled data of a.m. and p.m. dose as well as within a.m. and p.m. dosing groups) is superior to that with placebo after 24 weeks of treatment.

Critère d'inclusion

  • Type II diabetes mellitus inadequate control

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