Value through Innovation27 July 2016

Clinical Study Results

  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.21
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, randomised, single-dose, two-way crossover study in healthy male and female subjects to evaluate the bioequivalence of Jentadueto® (two fixed dose combination tablets of linagliptin 2.5 mg and metformin 500 mg) compared with the free combination of linagliptin 5 mg and metformin 1000 mg tablets under fasting conditions

    Study Document Trial synopsis 1288.21 english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.11
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a fixed dose combination tablet of linagliptin/metformin extended release (2.5 mg/1000 mg) compared with the free combination of linagliptin and metformin extended release tablets in healthy subjects (an open-label, randomised, single dose, two-way crossover trial)

    Study Document Trial synopsis 1288.11_DR english
  • JENTADUETO ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1288.18
    Study Indication Diabetes Mellitus, Type 2
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase IIIb
    Study Title

    A phase III randomised, double-blind, double-dummy, parallel group study to compare the efficacy and safety of twice daily administration of the fix dose combination of Linagliptin 2.5 mg + metformin 500 mg, or of Linagliptin 2.5 mg + metformin 1000 mg, with the individual components of metformin (500 mg or 1000 mg, twice daily), and Linagliptin (5.0 mg, once daily) over 24 weeks in treatment naive type 2 diabetic patients with insufficient glycaemic control

    Study Document Trial synopsis 1288.18_DR english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.6
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of two different batches of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet (FDC) in healthy male and female volunteers (an open-label, randomised, single dose, two-way crossover, Phase I trial)

    Study Document Trial synopsis 1288.6_DR english
  • JENTADUETO ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1288.19
    Study Indication Diabetes Mellitus, Type 2
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    A Single-Dose, Comparative Bioavailability Study of Linagliptin/Metformin Hydrochloride 2.5 mg/500 mg Combination Tablets versus Linagliptin 2.5 mg Tablets Administered with Glucophage® 500 mg Tablets under Fasting Conditions

    Study Document Trial synopsis 1288.19 english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.5
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Characterisation of fixed dose combination tablets of linagliptin 2.5 mg/   metformin 850 mg or linagliptin 2.5 mg/metformin 500 mg and relative oral   bioavailability compared with single linagliptin 2.5 mg and metformin 850 mg or 500 mg tablets administered together to healthy Chinese male and female   volunteers in an open-label, randomised, single-dose, two-way crossover, phase I  study

    Study Document Trial synopsis 1288.5_CO english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.20
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of metformin under fed conditions after administration of a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination tablet compared with single linagliptin 2.5 mg and metformin 500 mg tablets administered together in healthy male and female volunteers, (an open-label, randomised, single dose, two-way crossover, Phase I trial)

    Study Document Trial synopsis 1288.20_CO english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.8
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of two newly developed extended release FDC tablet strengths (5mg/1000mg and 2.5 mg/750 mg) of Linagliptin/Metformin extended release compared with the free combination of Linagliptin and Metformin extended release in healthy subjects (an open-label, randomised, single dose, two-way crossover study)

    Study Document Trial synopsis 1288.8_CO english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.1
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet compared with single linagliptin 2.5 mg and metformin 1000 mg tablets administered together in healthy male and female volunteers (an open-label, randomised, single dose, two-way crossover, Phase I trial)

    Study Document Trial synopsis 1288.1_CO english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.2
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a 2.5 mg linagliptin / 500 mg metformin fixed dose combination tablet compared with single linagliptin 2.5 mg and metformin 500 mg tablets given concomitantly to healthy male and female volunteers (an open-label, randomised, single dose, two-way crossover, Phase I trial)

    Study Document Trial synopsis 1288.2 english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.3
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a 2.5 mg linagliptin / 850 mg metformin fixed dose combination tablet compared with single linagliptin 2.5 mg and metformin 850 mg tablets administered together in healthy male and female volunteers (an open-label, randomised, single dose, two-way crossover, Phase I trial)

    Study Document Trial synopsis 1288.3 english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.4
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet administered with and without food to healthy male and female subjects in an open, randomised, single-dose, two-way crossover, Phase I trial

    Study Document Trial synopsis 1288.4_CO english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.9
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a fixed dose combination tablet of linagliptin/metformin extended release (5 mg/1000 mg) compared with the free combination of linagliptin and metformin extended release tablets in healthy subjects (an open-label, randomised, single dose, two-way crossover trial)

    Study Document Trial synopsis 1288.9 english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.10
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a fixed dose combination tablet of linagliptin/metformin extended release (2.5 mg/750 mg) compared with the free combination of linagliptin and metformin extended release tablets in healthy subjects (an open-label, randomised, single dose, two-way crossover trial)

    Study Document Trial synopsis 1288.10_DR english
  • JENTADUETO ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1288.22
    Study Indication Diabetes Mellitus, Type 2
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase IV
    Study Title

    A regulatory requirement non interventional study to monitor the safety and effectiveness of Trajenta Duo® (Linagliptin/Metformin HCl, 2.5 mg/500 mg, 2.5 mg/850 mg and 2.5 mg/1000 mg, b.i.d) in Korean patients with type 2 diabetes mellitus. (SELINA Duo study)

    Study Document Trial synopsis 1288.22_PR english

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