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A 52-Week, International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III study with a 52-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozi...

Update Il y a 4 ans
Reference: EUCTR2007-005220-33

A 52-Week, International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III study with a 52-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination with Metformin compared with Sulphonylurea in Combination with Metformin in Adult Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on Metformin Therapy Alone

Woman and Man

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Extract

To examine whether, after 52 weeks of oral administration of double-blind treatment, the absolute change from baseline in HbA1c level with dapagliflozin plus metformin is non-inferior to glipizide (sulphonylurea) plus metformin in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone. Objectives after the 52-week extension period: - To assess the same safety and tolerability parameters as for the first 52 weeks, over 104 weeks treatment - To assess the maintenance of efficacy of dapagliflozin plus metformin over 104 weeks of treatment

Inclusion criteria

  • Type 2 Diabetes

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