Value through Innovation27 July 2016

Clinical Study Results

  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.28
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III randomised, double-blind, active-controlled parallel group efficacy and safety study of BI 10773 compared to glimepiride administered orally during 104 weeks with a 104 week extension period in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin treatment

    Study Document Lay summary 1245.28 main report english Lay summary 1245.28 final report english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.25
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IIIa
    Study Title

    A Phase III, multicentre, international, randomised, parallel group, double blind cardiovascular safety study of BI 10773 (10 mg and 25 mg administered orally once daily) compared to usual care in type 2 diabetes mellitus patients with increased cardiovascular risk

    Study Document Lay summary 1245.25 english
  • GLYXAMBI ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1275.19
    Study Indication Diabetes Mellitus, Type 2
    Product GLYXAMBI ®
    Generic Name Empagliflozin + Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, double-blind, parallel group, 52 week study to evaluate efficacy and safety of once daily empagliflozin and linagliptin fixed dose combination compared with linagliptin plus placebo in Japanese type 2 diabetes mellitus patients with insufficient glycaemic control after 16 weeks treatment with once daily linagliptin 5 mg.

    Study Document Lay summary 1275.19 english
  • GLYXAMBI ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1275.13
    Study Indication Diabetes Mellitus, Type 2
    Product GLYXAMBI ®
    Generic Name Empagliflozin + Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, double-blind, parallel group, 24-week study to evaluate efficacy and safety of once daily empagliflozin 10 mg and linagliptin 5 mg fixed dose combination compared with empagliflozin 10 mg plus placebo and a 52- week study to evaluate efficacy and safety of once daily empagliflozin 25 mg and linagliptin 5 mg fixed dose combination compared with empagliflozin 25 mg plus placebo (including a 28-week extension period to investigate the longterm safety) in patients with type 2 diabetes mellitus and insufficient glycaemic control after 16-week treatment with empagliflozin (10 mg or 25 mg) alone once daily

    Study Document Lay summary 1275.13 english

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