Value through Innovation27 July 2016

Clinical Study Results

  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.43
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, double-blind, placebo-controlled, parallel group, safety and efficacy study of BI 1356 (5 mg), compared to placebo as add on to pre-existing antidiabetic therapy (insulin or any combination with insulin; sulphonylurea or glinides as monotherapy; pioglitazone or any other antidiabetics, excluding only DPP-4 inhibitors other than BI 1356) over 52 weeks in type 2 diabetic patients with severe chronic renal impairment

    Study Document Trial synopsis 1218.43_CO english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.15
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo controlled, parallel group 24 week study to assess the efficacy and safety of linagliptin (5 mg) in combination with 30 mg pioglitazone (both administered orally once daily), compared to 30 mg pioglitazone plus placebo in drug-naive or previously treated type 2 diabetic patients with insufficient glycaemic control

    Study Document Trial synopsis 1218.15_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.17
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled parallel group efficacy and safety study of linagliptin (5 mg administered orally once daily) over 24 weeks in type 2 diabetic patients with insufficient glycaemic control despite metformin therapy

    Study Document Trial synopsis 1218.17_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.18
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled parallel group efficacy and safety study of linagliptin (5 mg) administered orally once daily over 24 weeks in type 2 diabetic patients with insufficient glycaemic control despite a therapy of metformin in combination with a sulphonylurea

    Study Document Trial synopsis 1218.18_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.20
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, active-controlled parallel group efficacy and safety study of linagliptin (5 mg, administered orally once daily) compared to glimepiride (1 to 4 mg once daily) over two years, in type 2 diabetic patients with insufficient glycaemic control despite metformin therapy

    Study Document Trial synopsis 1218.20_DS_CO english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.40
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase IIIb
    Study Title

    A 78 week open-label extension to trials assessing the safety and efficacy of linagliptin (5 mg) as monotherapy or in combination with other antidiabetic medications in type 2 diabetic patients

    Study Document Trial synopsis 1218.40_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.46
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III randomised, double-blind, placebo-controlled parallel group study to compare the efficacy and safety of twice daily administration of the free 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 mg, once daily) over 24 weeks in drug naive or previously treated (4 weeks washout and 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control

    Study Document Trial synopsis 1218.46_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.50
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled, parallel group efficacy and safety study of linagliptin (BI 1356) (5 mg), administered orally once daily for 18 weeks followed by a 34 week double-blind extension period (placebo patientsswitched to glimepiride) in Type 2 diabetic patients with insufficient glycaemic control for whom metformin therapy is inappropriate (intolerability or contraindication)

    Study Document Trial synopsis 1218.50_DS_CO english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.55
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    An open label, Phase I trial to investigate the pharmacokinetics and pharmacodynamics of Linagliptin (BI 1356) 5 mg after single and multiple oral administration in patients with Type 2 diabetes mellitus of African American origin for 7 days

    Study Document Trial synopsis 1218.55_DS_CO english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.62
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double-blind, placebo-controlled, 3 parallel group efficacy and safety study of linagliptin 2.5 mg twice daily versus 5 mg once daily over 12 weeks as add-on therapy to a twice daily dosing regimen of metformin in patients with type 2 diabetes mellitus and insufficient glycaemic control

    Study Document Trial synopsis 1218.62_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.37
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase IIa
    Study Title

    A 4-week, randomized, double blind, double dummy, placebo controlled, parallel group study comparing the influence of BI 1356 (5 mg) and sitagliptin (100 mg) administered orally once daily on various biomarkers in type 2 diabetic patients

    Study Document Trial synopsis 1218.37 english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.5
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomized, double-blind, placebo-controlled, five parallel group study investigating the efficacy and safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg administered orally once daily) over 12 weeks in drug naive and treated patients with Type 2 diabetes with insufficient glycemic control (study includes an open-label metformin treatment arm)

    Study Document Trial synopsis 1218.5_DS_CO english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.6
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double-blind, placebo-controlled, five parallel groups study investigating the efficacy and safety of BI 1356 (1 mg, 5 mg and 10 mg administered orally once daily) over 12 weeks as add-on therapy in patients with type 2 diabetes and insufficient glycaemic control despite metformin therapy, including an open-label glimepiride treatment arm

    Study Document Trial synopsis 1218.6_DS_CO english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.16
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controled parallel group efficacy and safety study of linagliptin (5 mg administered orally once daily) over 24 weeks, in drug naive or previously treated (6 weeks washout) type 2 diabetic patientswith insufficient glycaemic control

    Study Document Trial synopsis 1218.16_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.23
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A double-blind phase III study to evaluate the efficacy of BI 1356 5 mg and 10 mg vs. placebo for 12 weeks and vs. voglibose 0.6 mg for 26 weeks in patients with type 2 diabetes mellitus and insufficient glycaemic control, followed by an extension study to 52 weeks to evaluate long-term safety

    Study Document Trial synopsis 1218.23_DS_CO english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.35
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A randomized, double-blind, placebo-controlled parallel group efficacy and safety study of BI 1356 (5 mg administered orally once daily) over 18 weeks in Type 2 diabetic patients with insufficient glycaemic control (HbA1c 7.0-10%) despite background therapy with a sulphonylurea drug

    Study Document Trial synopsis 1218.35_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.52
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III randomised, double-blind parallel group extension study to   investigate the safety and efficacy of twice daily administration of the free   combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46

    Study Document Trial synopsis 1218.52_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.63
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of linagliptin (5 mg), administered orally once daily over 24 weeks in type 2 diabetic patients (age 70 years) with insufficient glycaemic control (HbA 1c 7.0%) despite metformin and/or sulphonylurea and/or insulin therapy

    Study Document Trial synopsis 1218.63_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.36
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III randomised, double-blind, placebo-controlled, parallel group efficacy and safety study of Linagliptin (5 mg), administered orally once daily for at least 52 weeks in type 2 diabetic patients in combination with basal insulin therapy

    Study Document Trial synopsis 1218.36_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.75
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase IIIb
    Study Title

    A Phase IIIb, 24-week, randomised, placebo-controlled, double-blinded, efficacy   and safety study of linagliptin in Black/African American patients with type 2   diabetes with a MTT sub-study

    Study Document Trial synopsis 1218.75_DS_CO english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.78
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    An open label, randomised, parallel group safety and efficacy study of linagliptin (5 mg administered orally once daily) over 52 weeks in patients with type 2 diabetes mellitus and insufficient glycaemic control despite background mono-therapy with an approved antidiabetic drug

    Study Document Trial synopsis 1218.78_CO english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.61
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III, randomised, double-blind, placebo-controlled parallel group efficacy and safety study of Linagliptin 5 mg administered orally once daily over 24 weeks in type 2 diabetic patients with insufficient glycaemic control despite a therapy of metformin in combination with pioglitazone

    Study Document Trial synopsis 1218.61_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.65
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled parallel group efficacy and safety study of linagliptin (5 mg administered orally once daily) over 24 weeks in type 2 diabetic patients with insufficient glycaemic control despite metformin therapy in Asian population

    Study Document Trial synopsis 1218.65_CO english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.64
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, double-blind, placebo-controlled parallel group safety   and efficacy study of linagliptin (5 mg administered orally once daily) over 12 weeks followed by a 40 week double-blind extension period (placebo patients   switched to glimepiride) in drug naive or previously treated type 2 diabetic   patients with moderate to severe renal impairment and insufficient glycaemic   control

    Study Document Trial synopsis 1218.64_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.66
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled parallel group efficacy and   safety study of Linagliptin (5 mg administered orally once daily) over 24 weeks, in drug naive or previously treated type 2 diabetic patients with insufficient glycaemic control

    Study Document Trial synopsis 1218.66_CO english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.94
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase IV
    Study Title

    A Post-Marketing Surveillance Study on the Safety, Tolerability and Efficacy of   Linagliptin among Filipino patients with type 2 Diabetes Mellitus

    Study Document Trial statement 1218.94_CO english Trial synopsis 1218.94_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.60
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised, double-blind, double-dummy, active-comparator controlled study investigating the efficacy and safety of linagliptin co-administered with metformin QD at evening time versus metformin BID over 14 weeks in treatment naive patients with type 2 diabetes mellitus and insufficient glycaemic control

    Study Document Trial synopsis 1218.60_CO english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.83
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase IV
    Study Title

    A 24-week, randomized, double-blind, active-controlled, parallel group trial to assess the superiority of oral linagliptin and metformin compared to linagliptin monotherapy in newly diagnosed, treatment-naive, uncontrolled Type 2 Diabetes Mellitus patients

    Study Document Trial synopsis 1218.83_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.105
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Randomized, three period cross over, double blind, double dummy study in type 2 diabetic patients to assess the ENDOTHElial effects of LINAgliptin, glimepiride and placebo therapy for 28 days ('ENDOTHELINA')

    Study Document Trial synopsis 1218.105 english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.1
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmcodynamics of single rising oral doses of BI 1356 BS as a solution at dose level 5 mg and tablets at dose levels 25 - 1200 mg administered to healthy male subjects. A randomised, double-blind, placebo-controlled trial, including an open-label intra-subject bioavailability comparison of 100 mg BI 1356 BS as a tablet and as a solution.

    Study Document Trial synopsis 1218.1_CO english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.2
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase Ib
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising oral doses (1, 2.5, 5, 10, and 25 mg q.d. for 12 days) of BI 1356 BS as powder in the bottle (PIB) in patients with type 2 diabetes (randomised, double-blind, placebo-controlled within the dose groups).

    Study Document Trial synopsis 1218.2_CO english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.3
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase Ib
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses (2.5, 5, and 10 mg q.d. for 28 days) of BI 1356 BS as tablet in patients with type 2 diabetes (randomised, double-blind, placebo-controlled within the dose groups).

    Study Document Trial synopsis 1218.3_CO english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.4
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability of both BI 1356 BS and metformin after co-administration compared to the bioavailability of multiple oral doses of BI 1356 BS 10 mg daily alone and metformin 850 mg three times a day alone in healthy male volunteers (an open-label, randomized, crossover study)

    Study Document Trial synopsis 1218.4_CO english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.7
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the metabolism and pharmacokinetics of 10 mg [14C]BI 1356 BS administered orally compared to 5 mg [14C]BI 1356 BS administered intravenously in healthy male volunteers in an open label single dose parallel group design study

    Study Document Trials synopsis 1218.7_CO english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.9
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    The effect of multiple oral doses of BI 1356 BS as tablets once daily for six days on the pharmacokinetics, safety and tolerability of multiple oral doses of 40 mg simvastatin given once daily for 20 days and on the pharmacokinetics of its metalbolite simvastatin acid. An open-label study in healthy male volunteers

    Study Document Trial synopsis 1218.9 english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.8
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of 1 mg and 10 mg BI 1356 BS as powder in the bottle (PIB) reconstituted with 0.1% tartaric acid compared to 1 mg and 10 mg BI 1356 BS as tablets as single oral administration in healthy male volunteers (separately at each dose level) including the influence of food (standardised high fat breakfast) on the bioavailability of 10 mg BI 1356 BS as tablet in a single dose, open-label, randomised, two-way (1 mg) and three-way (10 mg) crossover trial

    Study Document Trial synopsis 1218.8_CO english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.10
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising doses (0.5 mg to 10 mg) of BI 1356 BS as formulation for intravenous administration in healthy male volunteers. A randomised, single-blind, placebo-controlled trial, including a crossover intra-subject bioavailability comparison of 5 mg BI 1356 BS iv solution and 10 mg BI 1356 BS as tablet

    Study Document Trial synopsis 1218.10_CO english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.11
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase Ia
    Study Title

    Safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising oral doses (1 to 10 mg) and multiple rising oral doses (2.5 to 10 mg once daily for 12 days) of BI 1356 BS in healthy male volunteers (a randomised, double-blind, placebo-controlled within dose groups clinical trial)

    Study Document Trial synopsis 1218.11_CO english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.12
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase II
    Study Title

    A randomised, double-blind, placebo-controlled within a treatment group, multiple dose phase II study of BI 1356 BS (0.5 mg, 2.5 mg, and 10 mg in tablet q.d. administered orally for 28 days) to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in Japanese patients with type 2 diabetes mellitus

    Study Document Trial synopsis 1218.12 english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.13
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Relative Bioavailability of both BI 1356 and pioglitazone after co-administration compared to the bioavailability of multiple oral doses of BI 1356 10 mg qd alone and pioglitazone 45 mg qd alone in healthy male and female volunteers (an open label, randomised, multiple-dose, two-way crossover study).

    Study Document Trial synopsis 1218.13_CO english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.25
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability of BI 1356 after single oral administration of 5 mg BI 1356 given as tablet formulation TF IIb relative to tablet formulation TF II and tablet formulation iFF in healthy male volunteers (an open label, randomised, single-dose, three-way crossover study)

    Study Document Trial synopsis 1218.25 english
  • TRADJENTA ® - Renal Insufficiency
    Clinical Study Number 1218.26
    Study Indication Renal Insufficiency
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, pharmacodynamics, safety and tolerability of single and multiple 5 mg doses of BI 1356 tablets in patients with different degrees of renal impairment in comparison to subjects with normal renal function in a monocentric, open-label, parallel-group trial

    Study Document Trial synopsis 1218.26_CO english
  • TRADJENTA ® - Hepatic Insufficiency
    Clinical Study Number 1218.27
    Study Indication Hepatic Insufficiency
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics and pharmacodynamics of BI 1356 5 mg once daily in male and female subjects with different degrees of liver impairment (Child Pugh classification A-C) as compared to male and female healthy subjects (a non-blinded, parallel group study of phase I)

    Study Document Trial synopsis 1218.27_CO english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.28
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a single oral dose of warfarin (10 mg qd) after co administration with multiple oral doses of BI 1356 (5 mg qd) compared to the bioavailability of a single oral dose of warfarin (10 mg qd) alone in healthy male volunteers (an open label, two periods, fixed-sequence, clinical phase I study)

    Study Document Trial synopsis 1218.28_CO english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.29
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of digoxin after co-administration of multiple oral doses of digoxin (0.25 mg qd) and multiple oral doses of BI 1356 (5 mg qd) compared to the bioavailability of multiple oral doses of digoxin (0.25 mg qd) alone in healthy male and female volunteers (an open-label, randomized, two-way crossover clinical phase I study)

    Study Document Trial synopsis 1218.29_CO english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.30
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of BI 1356 and glyburide after concomitant administration of multiple oral doses of BI 1356 5 mg once daily and a single oral dose of glyburide 1.75 mg compared with the bioavailability of BI 1356 and glyburide after each treatment given alone in healthy male and female volunteers (an open label, randomised, two-way crossover study of phase I)

    Study Document Trial synopsis 1218.30 english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.31
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a single oral dose of BI 1356 (5 mg) after co-administration with multiple oral doses of ritonavir (200 mg bid for 3 days) compared to the bioavailability of a single oral dose of BI 1356 (5 mg) alone in healthy male volunteers (an open-label, randomized, two-way crossover, clinical phase I study)

    Study Document Trial synopsis 1218.31_CO english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.32
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Assessment of the effect of 5 mg and 100 mg of BI 1356 as single dose on the QT interval in healthy female and male subjects. A randomised, placebo controlled, double-blind, four-way crossover study with moxifloxacin as positive control.

    Study Document Trial synopsis 1218.32_CO english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.33
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Assessment of dose proportionality of different dose strengths of linagliptin tablets after oral administration to healthy male and female volunteers in an open, randomised, multiple-dose, three-period crossover, phase I trial

    Study Document Trial synopsis 1218.33 english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.34
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Relative Bioavailability of a 5 mg BI 1356 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 1218.34 english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.44
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    An open, two-period, fixed-sequence, phase I trial to evaluate the effect of multiple doses of BI 1356 on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel

    Study Document Trial synopsis 1218.44 english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.45
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics and pharmacodynamics of multiple 5 mg doses of BI 1356 p.o. given once daily compared to multiple 2.5 mg doses given twice daily in healthy male and female volunteers. A monocentric, open label, cross-over trial

    Study Document Trial synopsis 1218.45 english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.47
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Relative oral bioavailability of a fixed dose combination tablet of BI 1356 2.5 mg / metformin 1000 mg, compared with single BI 1356 2.5 mg and metformin 1000 mg tablets administered together to healthy male and female subjects in an open, randomised, single-dose, two-way crossover, phase I trial

    Study Document Trial synopsis 1218.47 english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.57
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of two strengths (1000 mg and 500 mg) of two different metformin tablets administered to healthy male and female subjects in an open, randomised, single-dose, two-period crossover, phase I trial

    Study Document Trial synopsis 1218.57 english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.58
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics of single and multiple oral doses of 5 mg BI 1356 in healthy male and female Chinese volunteers

    Study Document Trial synopsis 1218.58_CO english
  • TRADJENTA ® - Healthy
    Clinical Study Number 1218.67
    Study Indication Healthy
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    An open label, two-period, fixed sequence, phase 1 trial to evaluate the effect of multiple doses of rifampicin on the multiple-dose pharmacokinetics of linagliptin

    Study Document Trial synopsis 1218.67 english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.56
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double-blind, placebo-controlled, parallel group dose-finding study of linagliptin (1 and 5 mg administered orally once daily) over 12 weeks in children and adolescents, from 10 to 17 years of age, with type 2 diabetes mellitus

    Study Document Trial synopsis 1218.56_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.89
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase IIIb
    Study Title

    A phase IIIb, multicenter, multinational, randomized, double-blind, placebo controlled, parallel group study to evaluate the glycemic and renal efficacy of once daily administration of linagliptin 5 mg for 24 weeks in type 2 diabetes patients, with micro- or macroalbuminuria (30-3000mg/g creatinine) on top of current treatment with Angiotensin ConvEnzyme inhibitor or Angiotensin Receptor Blocker - MARLINA (Efficacy, safety & Modification of Albuminuria in type 2 diabetes subjects with Renal disease with LINAgliptin)

    Study Document Trial synopsis 1218.89 english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.178
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase IV
    Study Title

    Clinical characteristics and practice patterns of type 2 diabetes mellitus (T2DM) patients treated with oral antidiabetic drugs (OADs) in Japan: analysis of medical and health care database of the Medical Data Vision (MDV)

    Study Document Trial synopsis 1218.178 english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.149
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase IV
    Study Title

    A 24 week randomized, double-blind, placebo-controlled, parallel group, efficacy and safety trial of once daily linagliptin, 5 milligrams orally, as add on to basal insulin in elderly Type 2 Diabetes Mellitus patients with insufficient glycaemic control

    Study Document Trial synopsis 1218.149 english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.104
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase IV
    Study Title

    A regulatory requirement non interventional study to monitor the safety and effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean patients with type 2 diabetes mellitus (SELINA study)

    Study Document Trial synopsis 1218.104 english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.95
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance study on Long Term Drug Use of Trazenta® Tablets in Patients with type 2 Diabetes Mellitus

    Study Document Trial synopsis 1218.95 english

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