A 52-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Monotherapy [Ensayo clínico fase IIIb/IV multicéntrico, aleatorizado, doble ciego, con control activo, de 52 semanas de duración, para evaluar la eficacia y tolerabilidad de saxagliptina comparada con glimepirida en pacientes ancianos con diabetes tipo 2 con un control glucémico inadecuado en tratamiento con metfomina en monoterapia]

Trial Profile

A 52-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Monotherapy [Ensayo clínico fase IIIb/IV multicéntrico, aleatorizado, doble ciego, con control activo, de 52 semanas de duración, para evaluar la eficacia y tolerabilidad de saxagliptina comparada con glimepirida en pacientes ancianos con diabetes tipo 2 con un control glucémico inadecuado en tratamiento con metfomina en monoterapia]

Completed
Phase of Trial: Phase IV

Latest Information Update: 04 Nov 2016

At a glance

  • Drugs Glimepiride (Primary) ; Saxagliptin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Acronyms GENERATION
  • Sponsors AstraZeneca
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 04 Nov 2016 Results of post-hoc analysis assessing beta-cell function (n=720) published in the Clinical Therapeutics.
    • 09 Jun 2015 Post hoc analysis n=720 (baseline B-cell function and hypoglycaemia risk) presented at the 75th Annual Scientific Sessions of the American Diabetes Association.
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