Value through Innovation27 July 2016

Clinical Study Results

  • GLYXAMBI ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1275.1
    Study Indication Diabetes Mellitus, Type 2
    Product GLYXAMBI ®
    Generic Name Empagliflozin + Linagliptin
    Lab Code
    Clinical Phase IIIa
    Study Title

    A phase III randomized, double-blind, parallel group study to evaluate the efficacy and safety of once daily oral administration of BI 10773 25 mg/linagliptin 5 mg and BI 10773 10 mg/linagliptin 5 mg Fixed Dose Combination tablets compared with the individual components (BI 10773 25 mg, BI 10773 10 mg, and linagliptin 5 mg) for 52 weeks in treatment naive and metformin treated patients with type 2 diabetes mellitus with insufficient glycaemic control

    Study Document Trial synopsis 1275.1_DS_DR english
  • GLYXAMBI ® - Healthy
    Clinical Study Number 1275.3
    Study Indication Healthy
    Product GLYXAMBI ®
    Generic Name Empagliflozin + Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability investigations of a 25 mg BI 10773 / 5 mg linagliptin fixed dose combination (FDC) tablet (formulation A1) including the comparison with its mono-components, the comparison with a second FDC tablet (formulation A3), and the investigation of food (an open-label, randomised, single dose, crossover, Phase I trial in healthy male and female volunteers)

    Study Document Trial synopsis 1275.3_DR english
  • GLYXAMBI ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1275.9
    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 25 mg compared to placebo, all administered as oral fixed dose combinations with linagliptin 5 mg, in patients with type 2 diabetes mellitus and insufficient glycaemic control after 16 weeks treatment with linagliptin 5 mg once daily on metformin background therapy.

    Study Document Trial synopsis 1275.9_DR english
  • GLYXAMBI ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1275.10
    Study Indication Diabetes Mellitus, Type 2
    Product GLYXAMBI ®
    Generic Name Empagliflozin + Linagliptin
    Lab Code
    Clinical Phase IIIb
    Study Title

    A phase III, randomized, double-blind, parallel group study to evaluate the efficacy and safety of linagliptin 5 mg compared to placebo, administered as oral fixed dose combination with empagliflozin 10 mg or 25 mg for 24 weeks, in patients with type 2 diabetes mellitus and insufficient glycaemic control after 16 weeks of treatment with empagliflozin 10 mg or 25 mg on metformin background therapy

    Study Document Trial synopsis 1275.10_DR english
  • GLYXAMBI ® - Healthy
    Clinical Study Number 1275.21
    Study Indication Healthy
    Product GLYXAMBI ®
    Generic Name Empagliflozin + Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a fixed dose combination tablet of empagliflozin/linagliptin compared with the free combination of empagliflozin tablet and linagliptin tablet in healthy male and female subjects (an open-label, randomised, single-dose, crossover study)

    Study Document Trial synopsis 1275.21 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 Trial synopsis 1275.19 english Lay summary 1275.19 english
  • GLYXAMBI ® - Healthy
    Clinical Study Number 1275.17
    Study Indication Healthy
    Product GLYXAMBI ®
    Generic Name Empagliflozin + Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the effect of food on the bioavailability of empagliflozin / linagliptin fixed dose combination tablet in an open, randomised, single dose, two-way crossover study in healthy Japanese male subjects

    Study Document Trial synopsis 1275.17 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 Trial synopsis 1275.13 english Lay summary 1275.13 english

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