A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control. [Estudio de fase III, aleatorizado, doble ciego, controlado con placebo y con grupos paralelos, sobre la eficacia y seguridad de BI 10773 (10 mg y 25 mg administrado una vez al día) añadido a un tratamiento antidiabético preexistente durante 52 semanas en pacientes con diabetes tipo 2 e insuficiencia renal con un control glucémico insuficiente.]

Trial Profile

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control. [Estudio de fase III, aleatorizado, doble ciego, controlado con placebo y con grupos paralelos, sobre la eficacia y seguridad de BI 10773 (10 mg y 25 mg administrado una vez al día) añadido a un tratamiento antidiabético preexistente durante 52 semanas en pacientes con diabetes tipo 2 e insuficiencia renal con un control glucémico insuficiente.]

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Sep 2016

At a glance

  • Drugs Empagliflozin (Primary) ; Antihyperglycaemics
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms C-SCADE-5
  • Sponsors Boehringer Ingelheim; Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 16 Sep 2016 Results of a pooled analysis assessing risk of bone fracture presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes
    • 16 Sep 2016 Results assessing safety data from 18 trials presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes
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