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A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy Compared to Saxagliptin...

Mise à jour : Il y a 5 ans
Référence : EUCTR2006-000006-23

A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control. Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific. Protocol Amendment Number 03 - Site Specific - Germany (Version 2.0, Date 02-Oct-2006). Protocol Amendment Number 06 - Germany (Version 1.0, Date 12-Feb-2007). Protocol Amendment Number 07 - Site Specific (Version 1.0, Date 27-Sep-2007)

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Extrait

To compare, after 24 weeks of oral administration of double-blind treatment, the change from baseline in A1C level achieved with each dose of saxagliptin plus metformin IR compared to saxagliptin plus placebo and to metformin IR plus placebo in treatment-naïve subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥ 8% but ≤ 12%.

Critère d'inclusion

  • Type 2 diabetes mellitus

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