Value through Innovation27 July 2016

Clinical Study Results

  • BI 135585 - Diabetes Mellitus, Type 2
    Clinical Study Number 1283.2
    Study Indication Diabetes Mellitus, Type 2
    Product BI 135585
    Generic Name BI 135585
    Lab Code
    Clinical Phase Ib
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple-rising oral doses (5 to 100 mg q.d. for 14 days) of BI 135585 XX in patients with type 2 diabetes mellitus (randomised, double-blind, placebo-controlled within dose groups)

    Study Document Trial synopsis 1283.2 english
  • BI 44847 - Diabetes Mellitus, Type 2
    Clinical Study Number 1224.3
    Study Indication Diabetes Mellitus, Type 2
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of four multiple rising oral doses (50-800 mg b.i.d. or q.d. for 8 days) of BI 44847 as tablet in female and male patients with type 2 diabetes

    Study Document Trial synopsis 1224.3_CO english
  • BI 44847 - Diabetes Mellitus, Type 2
    Clinical Study Number 1224.4
    Study Indication Diabetes Mellitus, Type 2
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of 4 weeks treatment with three selected oral doses of BI 44847 as tablet in female and male patients with type 2 diabetes

    Study Document Trial synopsis 1224.4 english
  • 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 ® - 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
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.2
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of 4 multiple rising oral doses (2.5 mg to 100 mg) of BI 10773 tablets in male and female type 2 diabetic patients

    Study Document Trial synopsis 1245.2_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.4
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of 4 weeks treatment with three oral doses of BI 10773 as tablets in female and male patients with type 2 diabetes

    Study Document Trial synopsis 1245.4_DS_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.9
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IIb
    Study Title

    A Phase IIb, randomized, parallel group safety, efficacy, and pharmacokinetics study of BI 10773 (5 mg, 10 mg and 25 mg) administered orally once daily over 12 weeks compared double blind to placebo, as monotherapy, with an additional open-label metformin arm in type 2 diabetic patients with insufficient glycemic control

    Study Document Trial synopsis 1245.9_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.10
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IIb
    Study Title

    A Phase II, randomized, parallel group safety, efficacy, and pharmacokinetics study of BI 10773 (1 mg, 5 mg, 10 mg, 25 mg, and 50 mg) administered orally once daily over 12 weeks compared double blind to placebo with an additional open-label sitagliptin arm in type 2 diabetic patients with insufficient glycemic control despite metformin therapy

    Study Document Trial synopsis 1245.10_DS_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.12
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, pharmacodynamics, safety and tolerability of a single 50 mg dose of BI 10773 in patients with different degrees of renal impairment in comparison to subjects with type 2 diabetes and normal renal function in a monocentric, open-label, parallel-group, phase 1 trial

    Study Document Trial synopsis 1245.12 english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.15
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase II
    Study Title

    A Phase II, randomised, double-blind, placebo-controlled, multiple dose study to evaluate pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 (1 mg, 5 mg, 10 mg, and 25 mg) for 28 days in Japanese patients with type 2 diabetes mellitus

    Study Document Trial synopsis 1245.15_DS_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.19
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled parallel group efficacy and safety trial of BI 10773 (10 and 25 mg administered orally once daily) over 24 weeks in patients with type 2 diabetes mellitus with insufficient glycaemic control despite a background therapy of pioglitazone alone or in combination with metformin

    Study Document Trial synopsis 1245.19_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.20
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III randomised, double-blind, placebo-controlled, parallel group,efficacy and safety study of BI 10773 and sitagliptin administered orally over 24 weeks, in drug naive patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet and exercise

    Study Document Trial synopsis 1245.20_DS_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.23
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III randomised, double-blind, placebo-controlled, parallel group,efficacy and safety study of BI 10773 (10 mg, 25 mg) administered orally, once daily over 24 weeks in patients with type 2 diabetes mellitus with insufficient glycaemic control despite treatment with metformin alone or metformin in combination with a sulphonylurea

    Study Document Trial synopsis 1245.23_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.24
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IIb
    Study Title

    A 78 week open label extension to trials assessing the safety and efficacy of BI 10773 as monotherapy or in combination with metformin in type 2 diabetic patients

    Study Document Trial synopsis 1245.24_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.31
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III double-blind, extension, placebo-controlled parallel group safety and efficacy trial of BI 10773 (10 and 25 mg once daily) and sitagliptin (100 mg once daily) given for minimum 76 weeks (including 24 weeks of preceding trial) as monotherapy or with different background therapies in patients with type 2 diabetes mellitus previously completing trial 1245.19, 1245.20 or 1245.23

    Study Document Trial synopsis 1245.31_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.33
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IIb
    Study Title

    A phase IIb, randomized, double-blind, placebo-controlled, parallel group, safetyand efficacy study of BI 10773 (10 mg and 25 mg) administered orally, once daily over 78 weeks in type 2 diabetic patients receiving treatment with basal insulin (glargine, detemir, or NPH insulin only) with or without concomitant metformin and/or sulfonylurea therapy and insufficient glycemic control

    Study Document Trial synopsis 1245.33_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.36
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of BI 10773 (10 mg and 25 mg administered once daily) as add on to pre-existing antidiabetic therapy over 52 weeks in patients with type 2 diabetes mellitus and renal impairment and insufficient glycaemic control.

    Study Document Trial synopsis 1245.36_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.38
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IIb
    Study Title

    A double-blind, randomised, parallel group efficacy and safety study of BI 10773 (5 mg, 10 mg, 25 mg, and 50 mg) compared to placebo when administered orally once daily over 12 weeks, as monotherapy, in patients with type 2 diabetes and insufficient glycaemic control despite diet and exercise, followed by a 40 week randomised extension study to assess long term safety of BI 10773 (10 mg and 25 mg)

    Study Document Trial synopsis 1245.38_DS_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.42
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of pharmacodynamic and pharmacokinetic interactions between25 mg BI 10773 and 25 mg hydrochlorothiazide or 5 mg torasemide under steady state conditions in patients with type 2 diabetes mellitus in an open-label, randomised, cross-over trial

    Study Document Trial synopsis 1245.42 english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.44
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics and pharmacodynamics of BI 10773 after single and multiple oral doses of 10 mg and 25 mg BI 10773 in Chinese male and female type 2 diabetic patients

    Study Document Trial synopsis 1245.44_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.48
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of BI 10773 (10 mg, 25 mg) administered orally, once daily over 12 weeks in hypertensive patients with type 2 diabetes mellitus

    Study Document Trial synopsis 1245.48_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.49
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomized, double-blind, placebo-controlled, parallel group safety and efficacy study of BI 10773 (10 mg and 25 mg administered orally once daily) during 52 weeks in patients with type 2 diabetes mellitus and insufficient glycemic control on MDI insulin regimen alone or with metformin

    Study Document Trial synopsis 1245.49_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.52
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A 52-week, randomised, multi-centre, parallel group study to investigate the safety and efficacy of BI 10773 (10 mg or 25 mg administered orally once daily) as add-on therapy to an oral antidiabetic drug (sulfonylurea, biguanide, thiazolidinedione, alpha glucosidase inhibitor, DPP-IV inhibitor, or glinide) in patients with type 2 diabetes mellitus with insufficient glycaemic control

    Study Document Trial synopsis 1245.52_DS_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.53
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I, open-label, parallel-group study to investigate pharmacokinetics, pharmacodynamics and safety of a single 25 mg dose of Empagliflozin in Japanese type 2 diabetes patients with different degrees of renal impairment in comparison to type 2 diabetes patients with normal renal function

    Study Document Trial synopsis 1245.53_DS_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.39
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase II
    Study Title

    An open-label, phase II study to determine acute (after the first dose administration) and chronic (after 28 days of treatment) effects of the sodium-glucose co-transporter-2 (SGLT-2) inhibitor empagliflozin (BI 10773) (25 mg once daily) on pre and postprandial glucose homeostasis in patients with IGT and, type 2 diabetes mellitus and healthy subjects

    Study Document Trial synopsis 1245.39_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.35
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double-blind, placebo-controlled, parallel group, 4-week study to evaluate the efficacy of empagliflozin (10 mg and 25 mg administered orally once daily) in postprandial glucose and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus with insufficient glycaemic control

    Study Document Trial synopsis 1245.35_DR english
  • 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 Trial synopsis 1245.28_main report english Trial synopsis 1245.28_final report english 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 Trial synopsis 1245.25_DR english Lay summary 1245.25 english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.87
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, randomised, multicentre, single-dose, parallel group trial to evaluate pharmacokinetics and pharmacodynamics of empagliflozin in children and adolescents from 10 to less than 18 years of age with type 2 diabetes mellitus

    Study Document Trial synopsis 1245.87_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 ® - 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
  • 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
  • MICARDIS ® - Diabetes Mellitus, Type 2
    Clinical Study Number 502.398
    Study Indication Diabetes Mellitus, Type 2
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    A prospective, randomized, double-blind, double-dummy, forced titration, parallel group comparison, multicenter trial to compare the effects of either telmisartan (40-80 mg p.o. once daily) or ramipril (5-10 mg p.o. once daily) on renal endothelial dysfunction in hypertensive patients with type 2 diabetes and normo- or microalbuminuria over a treatment period of 9 weeks

    Study Document Trial synopsis 502.398_CO english
  • SYNJARDY ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1276.1
    Study Indication Diabetes Mellitus, Type 2
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase III
    Study Title

    A 24-week phase III randomized, double-blind, parallel group study to evaluate the efficacy and safety of twice daily oral administration of empagliflozin + metformin compared with the individual components of empagliflozin or metformin in drug naive patients with type 2 diabetes mellitus

    Study Document Trial synopsis 1276.1_DR english
  • SYNJARDY ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1276.10
    Study Indication Diabetes Mellitus, Type 2
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double blind, placebo controlled, parallel group efficacy and safety study of oral administration of empagliflozin twice daily versus once daily in two different daily doses over 16 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 1276.10_DR english
  • 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 ® - 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 ® - 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 ® - 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
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.66
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empaglifozin
    Lab Code
    Clinical Phase II
    Study Title

    An open-label mechanistic study to examine the effect of oral empagliflozin (25 mg q.d.) on kinetics of renal glucose reabsorption in patients with type 2 diabetes mellitus and healthy controls

    Study Document Trial synopsis 1245.66 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
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.98
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance in Japan on Drug Use of JARDIANCE® Tablets in Elderly Patients with type 2 Diabetes Mellitus

    Study Document Trial synopsis 1245.98 english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.122
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IV
    Study Title

    Characteristics of patients initiating empagliflozin or other non-insulin glucose lowering drugs in the United Kingdom

    Study Document Trial synopsis 1245.122 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
  • 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
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.29
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empaglifozin
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of empagliflozin (10 mg, 25 mg) administered orally, once daily over 24 weeks in hypertensive black/African American patients with type 2 diabetes mellitus

    Study Document Trial synopsis 1245.29 english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.106
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IV
    Study Title

    A 52-week randomised, double-blind, parallel group, safety and efficacy study of empagliflozin once daily as add-on therapy to glucagon-like peptide- 1 receptor agonist in Japanese type 2 diabetes mellitus patients with insufficient glycaemic control

    Study Document Trial synopsis 1245.106 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
  • 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
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.107
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empaglifozin
    Lab Code
    Clinical Phase IV
    Study Title

    A 52-week randomised, double-blind, placebo-controlled, parallel-group, efficacy and safety study of empagliflozin once daily, as add-on to insulin in Japanese patients with Type 2 diabetes mellitus with insufficient glycaemic control

    Study Document Trial synopsis 1245.107 english

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