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A randomized, double-blind, placebo-controlled, five parallel group study investigating the efficacy and safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg administered orally once daily) over 12 weeks i...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-002311-27

A randomized, double-blind, placebo-controlled, five parallel group study investigating the efficacy and safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg administered orally once daily) over 12 weeks in drug naïve and treated patients with Type 2 diabetes with insufficient glycemic control (study includes an open-label metformin treatment arm)

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Extrait

Investigate the efficacy, safety and tolerability of several doses of BI 1356 BS ( 0.5 mg, 2.5 mg and 5.0 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. An open label treatment arm with, metformin will be used for sensitivity analysis. Population pharmacokinetics of BI 1356 BS will also be assessed.

Critère d'inclusion

  • Patients with Type 2 diabetes

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