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A 24-Week, International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III study to Evaluate the Efficacy and Safety of Dapagliflozin in Combination with Metformin ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-004916-12

A 24-Week, International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III study to Evaluate the Efficacy and Safety of Dapagliflozin in Combination with Metformin compared with a DPP-4 inhibitor (Sitagliptin) in Combination with Metformin in Adult Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on Metformin Therapy Alone

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Extrait

To examine whether, after 24 weeks of oral administration of double-blind treatment, the change from baseline in glycosylated haemoglobin A1c (HbA1c) level with dapagliflozin 10 mg plus metformin is non-inferior to sitagliptin (DPP-4 inhibitor) 100 mg plus metformin in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.

Critère d'inclusion

  • Type 2 diabetes mellitus

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