Value through Innovation27 July 2016

Clinical Study Results

  • JARDIANCE ® - Diabetes Mellitus, Type 1
    Clinical Study Number 1245.78
    Study Indication Diabetes Mellitus, Type 1
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IIa
    Study Title

    A 28-day randomised, placebo-controlled, double-blind parallel group phase IIa trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of once daily oral doses of 2.5 mg, 10 mg, and 25 mg empagliflozin as adjunctive to insulin in patients with type 1 diabetes mellitus (EASE-1)

    Study Document Trial synopsis 1245.78 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 ® - Hepatic Insufficiency
    Clinical Study Number 1245.13
    Study Indication Hepatic Insufficiency
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, safety and tolerability of BI 10773 50 mg single dose in male and female subjects with different degrees of liver impairment (Child-Pugh classification A, B and C) as compared to male and female healthy subjects (a non-blinded, parallel group study of phase I)

    Study Document Trial synopsis 1245.13 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 ® - Healthy
    Clinical Study Number 1245.16
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Assessment of the effect of 25 mg and 200 mg of BI 10773 as single dose on the QT interval in healthy female and male subjects. A randomised, placebo controlled, double-blind, five-period crossover Phase-I-study with moxifloxacin as positive control

    Study Document Trial synopsis 1245.16_DR english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.18
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of both BI 10773 and warfarin and pharmacodynamics of warfarin after co-administration compared to multiple oral doses of BI 10773 (25 mg once daily) and a single oral dose of warfarin (25 mg) alone in healthy male volunteers (an open-label, crossover, clinical phase I study)

    Study Document Trial synopsis 1245.18_DR 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 ® - Healthy
    Clinical Study Number 1245.40
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a single oral dose of digoxin (0.5 mg) when administered alone or in combination with multiple oral doses of BI 10773(25 mg qd) in healthy male and female volunteers (an open-label, randomised,two-way crossover study)

    Study Document Trial synopsis 1245.40_CO english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.41
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, two-period, fixed-sequence trial to evaluate the effect of multiple doses of BI 10773 on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel in healthy premenopausal female volunteers

    Study Document Trial synopsis 1245.41_DR 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 ® - Healthy
    Clinical Study Number 1245.43
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of BI 10773 given alone and together with verapamil - an open-label, randomised, crossover trial in healthy subjects

    Study Document Trial synopsis 1245.43_DR 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 ® - Healthy
    Clinical Study Number 1245.45
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of multiple oral doses of BI 10773 (25 mg) and ramipril (5 mg) administered together compared to multiple oral doses of BI 10773 (25 mg) alone and ramipril (5 mg) alone in healthy male and female volunteers (an open-label, randomised, three-way crossover, clinical phase I study)

    Study Document Trial synopsis 1245.45_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 1
    Clinical Study Number 1245.46
    Study Indication Diabetes Mellitus, Type 1
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase II
    Study Title

    An open-label 8-week adjunctive-to-insulin and renal mechanistic pilot trial of BI 10773 in type 1 diabetes mellitus (the ATIRMA trial)

    Study Document Trial synopsis 1245.46_DS_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 ® - Healthy
    Clinical Study Number 1245.50
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of pioglitazone after co-administration with different doses of BI 10773 in healthy volunteers (an open-label, randomised, crossover, clinical phase I study)

    Study Document Trial synopsis 1245.50 english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.51
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of 25 mg BI 10773 (Final Formulation) compared to 25 mg BI 10773 XX (Trial Formulation 2) following oral administration in healthy male and female volunteers (an open-label, randomised, single-dose,two-way crossover study)

    Study Document Trial synopsis 1245.51_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 ® - Healthy
    Clinical Study Number 1245.58
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of single dose BI 10773 co-administered  with multiple doses of 600 mg gemfibrozil bid compared to single dose treatment of BI 10773 alone in healthy volunteers – a phase I, open-label, randomised, 2-way crossover trial

    Study Document Trial synopsis 1245.58_DR english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.63
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empaglifozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of BI 10773 and simvastatin after single and combined administration - an open-label, randomised, crossover trial in healthy subjects

    Study Document Trial synopsis 1245.63_DR english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.79
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empaglifozin
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the effect of food on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets in an open, randomised, single dose, three-period cross-over study in healthy male and female subjects

    Study Document Trial synopsis 1245.79_DR english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.83
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empaglifozin
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, open-label, three-way crossover trial to investigate the effect of rifampicin and probenecid on empagliflozin pharmacokinetics in healthy male and female subjects

    Study Document Trial synopsis 1245.83_DR english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.1
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses (0.5 mg to 800 mg) of BI 10773 as tablets administered to healthy male subjects. A randomised, placebo-controlled (within dose groups) and double-blind trial

    Study Document Trial synopsis 1245.1 english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.3
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    The effect of food on the bioavailability and pharmacokinetics of BI10773 tablets, administered as a single dose of 50 mg with and without food to healthy male volunteers in an open-label, randomised intraindividual crossover comparison design

    Study Document Trial synopsis 1245.3 english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.6
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of both BI 10773 and metformin after co-administration compared to multiple oral doses of BI 10773 (50 mg q.d.) alone and metformin (1000 mg b.i.d.) alone to healthy male volunteers (an open-label, randomised, crossover, clinical phase I study)

    Study Document Trial synopsis 1245.6 english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.7
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of both BI 10773 and glimepiride after co-coadministrationcompared to multiple oral doses of BI 10773 (50 mg q.d.) alone and a single dose of glimepiride (1 mg) alone in healthy male volunteers (an open-label, randomised, crossover, clinical phase I study)

    Study Document Trial synopsis 1245.7 english
  • JARDIANCE ® - Gastrointestinal Diseases
    Clinical Study Number 1245.8
    Study Indication Gastrointestinal Diseases
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    A phase I, open-label, single-dose trial to investigate the metabolism and pharmacokinetics of 50 mg [14C]-BI 10773 when administered as oral solution to healthy male volunteers

    Study Document Trial synopsis 1245.8_CO english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.17
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of both BI 10773 50 mg and pioglitazone 45 mg after co-administration compared to BI 10773 and pioglitazone alone in healthy male volunteers (an open-label, randomised, crossover, clinical phase I study)

    Study Document Trial synopsis 1245.17_CO english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.27
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of both BI 10773 and sitagliptin after co-administration compared to multiple oral doses of BI 10773 (50 mg q.d.) alone and sitagliptin (100 mg q.d.) alone in healthy male volunteers (an open-label, randomised, crossover, clinical phase I study)

    Study Document Trial synopsis 1245.27 english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.30
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of multiple doses BI 10773 50 mg and linagliptin 5 mg after concomitant administration compared to multiple doses of BI 10773 50 mg and linagliptin 5 mg administered alone to healthy male volunteers (an open-label, randomised, crossover, clinical phase I study)

    Study Document Trial synopsis 1245.30 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 ® - Healthy
    Clinical Study Number 1245.5
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I, randomised, double-blind, placebo-controlled (within dose groups) study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses (1 to 100 mg) of BI 10773 in healthy male volunteers

    Study Document Trial synopsis 1245.5_CO 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
  • 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
  • JARDIANCE ® - Diabetes Mellitus, Type 1
    Clinical Study Number 1245.113
    Study Indication Diabetes Mellitus, Type 1
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase II
    Study Title

    A phase II, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily, oral doses of empagliflozin as adjunctive to insulin therapy for 28 days in Japanese patients with type 1 diabetes mellitus

    Study Document Trial synopsis 1245.113 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
  • 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
  • JARDIANCE ® - Diabetes Mellitus, Type 1
    Clinical Study Number 1245.69
    Study Indication Diabetes Mellitus, Type 1
    Product JARDIANCE ®
    Generic Name Empaglifozin
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III, randomised, double blind, placebo-controlled, parallel group, efficacy, safety and tolerability trial of once daily, oral doses of Empagliflozin as Adjunctive to inSulin thErapy over 52 weeks in patients with Type 1 Diabetes Mellitus (EASE-2)

    Study Document Trial synopsis 1245.69 english
  • JARDIANCE ® - Diabetes Mellitus, Type 1
    Clinical Study Number 1245.72
    Study Indication Diabetes Mellitus, Type 1
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III, randomised, double blind, placebo-controlled, parallel group, efficacy, safety and tolerability trial of once daily, oral doses of Empagliflozin as Adjunctive to inSulin thErapy over 26 weeks in patients with Type 1 Diabetes Mellitus (EASE-3)

    Study Document Trial synopsis 1245.72 english

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