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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, PO, BID, in Combination with Metformin in Subjects...

Mise à jour : Il y a 5 ans
Référence : EUCTR2009-010224-25

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, PO, BID, in Combination with Metformin in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin, Alone

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Extrait

The primary endpoint is the change in A1C from baseline to Week 12 (or the last post baseline measurement prior to Week 12, if no Week 12 assessment is available). The primary comparison is between the saxagliptin 2.5 mg BID (plus stable background metformin IR) and placebo (plus stable background metformin IR) treatment groups.

Critère d'inclusion

  • Type 2 diabetes mellitus

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