Value through Innovation27 July 2016

Clinical Study Results

  • Linagliptin + Pioglitazone - Healthy
    Clinical Study Number 1264.1
    Study Indication Healthy
    Product Linagliptin + Pioglitazone
    Generic Name Linagliptin + Pioglitazone
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of two fixed dose combination tablets of linagliptin 5 mg/pioglitazone 45 mg compared with single linagliptin 5 mg and pioglitazone 45 mg tablets administered together to healthy male and female subjects (open, randomised, single dose, threeperiod crossover phase I trial)

    Study Document Trial synopsis 1264.1 english
  • Linagliptin + Pioglitazone - Diabetes Mellitus, Type 2
    Clinical Study Number 1264.3
    Study Indication Diabetes Mellitus, Type 2
    Product Linagliptin + Pioglitazone
    Generic Name Linagliptin + Pioglitazone
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind parallel group study to compare the efficacy and safety of initial combination therapy with linagliptin 5 mg + pioglitazone 15 mg, 30 mg, or 45 mg, vs. monotherapy with pioglitazone (15 mg, 30 mg, or 45 mg) or linagliptin 5 mg once daily for 30 weeks, followed by a blinded trial period on linagliptin 5 mg + pioglitazone 30 or 45 mg versus pioglitazone monotherapy 30 or 45 mg or linagliptin 5 mg for up to 54 weeks in type 2 diabetic patients with insufficient glycaemic control on diet and exercise

    Study Document Trial synopsis 1264.3_DR english
  • Linagliptin + Pioglitazone - Healthy
    Clinical Study Number 1264.14
    Study Indication Healthy
    Product Linagliptin + Pioglitazone
    Generic Name Linagliptin + Pioglitazone
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a fixed dose combination tablet of linagliptin 5 mg / pioglitazone 30 mg compared with its mono-components in healthy male and female subjects (an open-label, randomised, single-dose, replicate design study with two treatments in four crossover periods)

    Study Document Trial synopsis 1264.14_DR english

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