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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01131676
Registration number
NCT01131676
Ethics application status
Date submitted
26/05/2010
Date registered
27/05/2010
Date last updated
16/05/2016
Titles & IDs
Public title
BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).
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Scientific 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
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Secondary ID [1]
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2009-016178-33
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Secondary ID [2]
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1245.25
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BI 10773 low dose
Treatment: Drugs - Placebo BI 10773 high dose
Treatment: Drugs - BI 10773 high dose
Treatment: Drugs - Placebo BI 10773 low dose
Treatment: Drugs - Placebo BI 10773 low dose
Treatment: Drugs - Placebo BI 10773 high dose
Experimental: BI 10773 low dose - BI 10773 tablets once daily
Experimental: BI 10773 high dose - BI 10773 tablets once daily
Placebo comparator: Placebo - Placebo tablets matching BI 10773
Treatment: Drugs: BI 10773 low dose
BI 10773 tablets once daily
Treatment: Drugs: Placebo BI 10773 high dose
Placebo tablets identical to BI 10773
Treatment: Drugs: BI 10773 high dose
BI 10773 tablets once daily
Treatment: Drugs: Placebo BI 10773 low dose
Placebo tablets identical to BI 10773
Treatment: Drugs: Placebo BI 10773 low dose
Placebo tablets identical to BI 10773
Treatment: Drugs: Placebo BI 10773 high dose
Placebo tablets identical to BI 10773
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke.
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Assessment method [1]
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Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), and non-fatal stroke.
Percentage of patients with the event are presented.
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Timepoint [1]
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From randomisation to individual end of observation, up to 4.6 years
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Secondary outcome [1]
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Percentage of Participants With the Composite of All Events Adjudicated (4-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), Non-fatal Stroke and Hospitalization for Unstable Angina Pectoris
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Assessment method [1]
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The composite of all events adjudicated (4-point MACE): cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction (excluding silent MI), non-fatal stroke and hospitalization for unstable angina pectoris.This is a key secondary endpoint of the trial.
Percentage of patients with the event are presented.
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Timepoint [1]
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From randomisation to individual end of observation, up to 4.6 years
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Secondary outcome [2]
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Percentage of Participants With Silent MI
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Assessment method [2]
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Silent MI; defined as presence in the ECG of:
* Any Q-wave in leads V2-V3 =0.02 seconds or QS complex in leads V2 and V3
* Q-wave =0.03 seconds and =0.1 mV deep or QS complex in leads I, II, aVL, aVF, or V4-V6 in any two leads of a contiguous lead grouping (I, aVL, V6; V4-V6; II, III, and aVF)
* R-wave =0.04 seconds in V1-V2 and R/S =1 with a concordant positive T-wave in the absence of a conduction defect.
It was also required that there had been no adjudicated and confirmed event of either acute MI, hospitalisation for unstable angina, coronary revascularisation procedures or stent thrombosis following randomisation up to and including the date of the specified ECG measurement.
Percentage of patients with the event are presented.
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Timepoint [2]
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From randomisation to individual end of observation, up to 4.6 years
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Secondary outcome [3]
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Percentage of Participants With Heart Failure Requiring Hospitalisation (Adjudicated)
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Assessment method [3]
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Heart failure requiring hospitalisation (adjudicated). Percentage of patients with the event are presented.
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Timepoint [3]
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From randomisation to individual end of observation, up to 4.6 years
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Secondary outcome [4]
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Percentage of Participants With New Onset Albuminuria
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Assessment method [4]
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New onset albuminuria defined as urine albumin / creatinine ratio (UACR) =30 mg/g.
Percentage of patients with the event are presented.
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Timepoint [4]
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From randomisation to individual end of observation, up to 4.6 years
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Secondary outcome [5]
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Percentage of Participants With New Onset Macroalbuminuria
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Assessment method [5]
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New onset macroalbuminuria defined as UACR \>300 mg/g. Percentage of patients with the event are presented.
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Timepoint [5]
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From randomisation to individual end of observation, up to 4.6 years
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Secondary outcome [6]
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Percentage of Participants With the Composite Microvascular Outcome
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Assessment method [6]
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Composite microvascular outcome defined as:
* Initiation of retinal photocoagulation
* Vitreous haemorrhage
* Diabetes-related blindness, or
* New or worsening nephropathy defined as:
* New onset of macroalbuminuria; or
* Doubling of serum creatinine level accompanied by an eGFR (based on modification of diet in renal disease (MDRD) formula) =45 mL/min/1.73m2; or
* Initiation of continuous renal replacement therapy, or
* Death due to renal disease. Percentage of patients with the event are presented.
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Timepoint [6]
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From randomisation to individual end of observation, up to 4.6 years
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Eligibility
Key inclusion criteria
Inclusion criteria:
1. Diagnosis of type 2 diabetes mellitus prior to informed consent
2. Male or female patients on diet and exercise regimen who are drug naive or pre treated with any background therapy. Antidiabetic therapy has to be unchanged for 12 weeks prior to randomization.
3. Glycosylated haemoglobin (HbA1c) of >= 7.0% and <=10% for patients on background therapy or HbA1c >= 7.0% and <= 9.0% for drug naive patients
4. Age >= 18 years
5. Body Mass index <= 45 at Visit 1
6. Signed and dated informed consent
7. High cardiovascular risk
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
2. Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase ALT or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at screening and/or run in.
3. Planned cardiac surgery or angioplasty within 3 months
4. Impaired renal function, defined as Glomerular Filtration Rate <30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) during screening or run in.
5. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
6. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
8. Contraindications to background therapy according to the local label
9. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus
11. Pre-menopausal women (last menstruation <+ 1 year prior to informed consent) who:
* are nursing or pregnant or
* are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomised partner
12. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
13. Participation in another trial with an investigational drug within 30 days prior to informed consent
14. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
15. Acute coronary syndrome, stroke or TIA within 2 months prior to informed consent
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2015
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Sample size
Target
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Accrual to date
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Final
7064
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Recruitment in Australia
Recruitment state(s)
QLD,SA
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Recruitment hospital [1]
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1245.25.61003 Boehringer Ingelheim Investigational Site - Herston
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Recruitment hospital [2]
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1245.25.61001 Boehringer Ingelheim Investigational Site - Ashford
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Recruitment hospital [3]
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1245.25.61002 Boehringer Ingelheim Investigational Site - Fullarton
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Recruitment postcode(s) [1]
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- Herston
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Recruitment postcode(s) [2]
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- Ashford
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Recruitment postcode(s) [3]
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- Fullarton
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Recruitment outside Australia
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State/province [104]
0
0
Brno
Query!
Country [105]
0
0
Czech Republic
Query!
State/province [105]
0
0
Jindrichuv Hradec
Query!
Country [106]
0
0
Czech Republic
Query!
State/province [106]
0
0
Praha 3
Query!
Country [107]
0
0
Czech Republic
Query!
State/province [107]
0
0
Usti nad Labem
Query!
Country [108]
0
0
Denmark
Query!
State/province [108]
0
0
Frederiksberg
Query!
Country [109]
0
0
Denmark
Query!
State/province [109]
0
0
Gentofte
Query!
Country [110]
0
0
Denmark
Query!
State/province [110]
0
0
Helsingør
Query!
Country [111]
0
0
Denmark
Query!
State/province [111]
0
0
København NV
Query!
Country [112]
0
0
Denmark
Query!
State/province [112]
0
0
Randers NØ
Query!
Country [113]
0
0
Denmark
Query!
State/province [113]
0
0
Slagelse
Query!
Country [114]
0
0
Estonia
Query!
State/province [114]
0
0
Tallinn
Query!
Country [115]
0
0
Estonia
Query!
State/province [115]
0
0
Tallin
Query!
Country [116]
0
0
Estonia
Query!
State/province [116]
0
0
Tartu
Query!
Country [117]
0
0
France
Query!
State/province [117]
0
0
Amiens
Query!
Country [118]
0
0
France
Query!
State/province [118]
0
0
Angers
Query!
Country [119]
0
0
France
Query!
State/province [119]
0
0
Bourg des cptes
Query!
Country [120]
0
0
France
Query!
State/province [120]
0
0
Corbeil Essonnes
Query!
Country [121]
0
0
France
Query!
State/province [121]
0
0
Derval
Query!
Country [122]
0
0
France
Query!
State/province [122]
0
0
Equeurdreville Haineville
Query!
Country [123]
0
0
France
Query!
State/province [123]
0
0
Fleury sur Orne
Query!
Country [124]
0
0
France
Query!
State/province [124]
0
0
Grenoble
Query!
Country [125]
0
0
France
Query!
State/province [125]
0
0
La Rochelle Cedex 1
Query!
Country [126]
0
0
France
Query!
State/province [126]
0
0
Le Creusot
Query!
Country [127]
0
0
France
Query!
State/province [127]
0
0
Narbonne Cedex
Query!
Country [128]
0
0
France
Query!
State/province [128]
0
0
Pessac
Query!
Country [129]
0
0
France
Query!
State/province [129]
0
0
Poitiers
Query!
Country [130]
0
0
France
Query!
State/province [130]
0
0
Saint Priez en Jarez
Query!
Country [131]
0
0
France
Query!
State/province [131]
0
0
Tours
Query!
Country [132]
0
0
Georgia
Query!
State/province [132]
0
0
Batumi
Query!
Country [133]
0
0
Georgia
Query!
State/province [133]
0
0
Kutaisi
Query!
Country [134]
0
0
Georgia
Query!
State/province [134]
0
0
Tbilisi
Query!
Country [135]
0
0
Greece
Query!
State/province [135]
0
0
Athens
Query!
Country [136]
0
0
Greece
Query!
State/province [136]
0
0
Larissa
Query!
Country [137]
0
0
Greece
Query!
State/province [137]
0
0
Nikaia
Query!
Country [138]
0
0
Greece
Query!
State/province [138]
0
0
Thessaloniki
Query!
Country [139]
0
0
Hong Kong
Query!
State/province [139]
0
0
Hong Kong
Query!
Country [140]
0
0
Hungary
Query!
State/province [140]
0
0
Budapest
Query!
Country [141]
0
0
Hungary
Query!
State/province [141]
0
0
Dunaujvaros
Query!
Country [142]
0
0
Hungary
Query!
State/province [142]
0
0
Gyula
Query!
Country [143]
0
0
Hungary
Query!
State/province [143]
0
0
Kisvarda
Query!
Country [144]
0
0
Hungary
Query!
State/province [144]
0
0
Szekszard
Query!
Country [145]
0
0
Hungary
Query!
State/province [145]
0
0
Szikszo
Query!
Country [146]
0
0
India
Query!
State/province [146]
0
0
Ahmedabad
Query!
Country [147]
0
0
India
Query!
State/province [147]
0
0
Bangalore
Query!
Country [148]
0
0
India
Query!
State/province [148]
0
0
Chennai
Query!
Country [149]
0
0
India
Query!
State/province [149]
0
0
Cochin
Query!
Country [150]
0
0
India
Query!
State/province [150]
0
0
Hyderabad
Query!
Country [151]
0
0
India
Query!
State/province [151]
0
0
Indore
Query!
Country [152]
0
0
India
Query!
State/province [152]
0
0
Jaipur
Query!
Country [153]
0
0
India
Query!
State/province [153]
0
0
Jalandhar
Query!
Country [154]
0
0
India
Query!
State/province [154]
0
0
Nagpur
Query!
Country [155]
0
0
India
Query!
State/province [155]
0
0
Nashik, Maharashtra
Query!
Country [156]
0
0
India
Query!
State/province [156]
0
0
Pune
Query!
Country [157]
0
0
India
Query!
State/province [157]
0
0
Secunderabad
Query!
Country [158]
0
0
India
Query!
State/province [158]
0
0
Varanasi
Query!
Country [159]
0
0
India
Query!
State/province [159]
0
0
Vijaywada
Query!
Country [160]
0
0
Indonesia
Query!
State/province [160]
0
0
Denpasar, Bali
Query!
Country [161]
0
0
Indonesia
Query!
State/province [161]
0
0
Depok
Query!
Country [162]
0
0
Indonesia
Query!
State/province [162]
0
0
Jakarta
Query!
Country [163]
0
0
Indonesia
Query!
State/province [163]
0
0
Malang
Query!
Country [164]
0
0
Indonesia
Query!
State/province [164]
0
0
Surabaya
Query!
Country [165]
0
0
Indonesia
Query!
State/province [165]
0
0
Yogyakarta
Query!
Country [166]
0
0
Israel
Query!
State/province [166]
0
0
Afula
Query!
Country [167]
0
0
Israel
Query!
State/province [167]
0
0
Hadera
Query!
Country [168]
0
0
Israel
Query!
State/province [168]
0
0
Haifa
Query!
Country [169]
0
0
Israel
Query!
State/province [169]
0
0
Holon
Query!
Country [170]
0
0
Israel
Query!
State/province [170]
0
0
Nahariya
Query!
Country [171]
0
0
Israel
Query!
State/province [171]
0
0
Safed
Query!
Country [172]
0
0
Israel
Query!
State/province [172]
0
0
Zerifin
Query!
Country [173]
0
0
Italy
Query!
State/province [173]
0
0
Bologna
Query!
Country [174]
0
0
Italy
Query!
State/province [174]
0
0
Campobasso
Query!
Country [175]
0
0
Italy
Query!
State/province [175]
0
0
Catanzaro
Query!
Country [176]
0
0
Italy
Query!
State/province [176]
0
0
Chieti
Query!
Country [177]
0
0
Italy
Query!
State/province [177]
0
0
Ferrara
Query!
Country [178]
0
0
Italy
Query!
State/province [178]
0
0
Firenze
Query!
Country [179]
0
0
Italy
Query!
State/province [179]
0
0
Foggia
Query!
Country [180]
0
0
Italy
Query!
State/province [180]
0
0
Napoli
Query!
Country [181]
0
0
Italy
Query!
State/province [181]
0
0
Padova
Query!
Country [182]
0
0
Italy
Query!
State/province [182]
0
0
Pisa
Query!
Country [183]
0
0
Italy
Query!
State/province [183]
0
0
Roma
Query!
Country [184]
0
0
Italy
Query!
State/province [184]
0
0
Venezia
Query!
Country [185]
0
0
Japan
Query!
State/province [185]
0
0
Chuo-ku, tokyo
Query!
Country [186]
0
0
Japan
Query!
State/province [186]
0
0
Gifushi, Gifu
Query!
Country [187]
0
0
Japan
Query!
State/province [187]
0
0
Hanyushi, Saitama
Query!
Country [188]
0
0
Japan
Query!
State/province [188]
0
0
Kamigyo-ku, Kyotoshi, Kyoto
Query!
Country [189]
0
0
Japan
Query!
State/province [189]
0
0
Kishiwadashi. Osaka
Query!
Country [190]
0
0
Japan
Query!
State/province [190]
0
0
Kita-ku, Nagoyashi, Aichi
Query!
Country [191]
0
0
Japan
Query!
State/province [191]
0
0
Kumamoto-shi, Kumamoto
Query!
Country [192]
0
0
Japan
Query!
State/province [192]
0
0
Matsudoshi, Chiba
Query!
Country [193]
0
0
Japan
Query!
State/province [193]
0
0
Mitoshi, Ibaraki
Query!
Country [194]
0
0
Japan
Query!
State/province [194]
0
0
Nishi-ku, Sapporoshi, Hokkaido
Query!
Country [195]
0
0
Japan
Query!
State/province [195]
0
0
Nodashi, Chiba
Query!
Country [196]
0
0
Japan
Query!
State/province [196]
0
0
Shimajiri-gun,Okinawa
Query!
Country [197]
0
0
Japan
Query!
State/province [197]
0
0
Toyamashi, Toyama
Query!
Country [198]
0
0
Japan
Query!
State/province [198]
0
0
Toyoakeshi, Aichi
Query!
Country [199]
0
0
Korea, Republic of
Query!
State/province [199]
0
0
Busan
Query!
Country [200]
0
0
Korea, Republic of
Query!
State/province [200]
0
0
Daegu
Query!
Country [201]
0
0
Korea, Republic of
Query!
State/province [201]
0
0
Daejeon
Query!
Country [202]
0
0
Korea, Republic of
Query!
State/province [202]
0
0
Daejoen
Query!
Country [203]
0
0
Korea, Republic of
Query!
State/province [203]
0
0
Goyang
Query!
Country [204]
0
0
Korea, Republic of
Query!
State/province [204]
0
0
Gwangju
Query!
Country [205]
0
0
Korea, Republic of
Query!
State/province [205]
0
0
Incheon
Query!
Country [206]
0
0
Korea, Republic of
Query!
State/province [206]
0
0
Pusan
Query!
Country [207]
0
0
Korea, Republic of
Query!
State/province [207]
0
0
Seoul
Query!
Country [208]
0
0
Korea, Republic of
Query!
State/province [208]
0
0
Suwon
Query!
Country [209]
0
0
Korea, Republic of
Query!
State/province [209]
0
0
Wonju
Query!
Country [210]
0
0
Malaysia
Query!
State/province [210]
0
0
Johor Bahru
Query!
Country [211]
0
0
Malaysia
Query!
State/province [211]
0
0
Kedah
Query!
Country [212]
0
0
Malaysia
Query!
State/province [212]
0
0
Kelantan
Query!
Country [213]
0
0
Malaysia
Query!
State/province [213]
0
0
Kota Kinabalu
Query!
Country [214]
0
0
Malaysia
Query!
State/province [214]
0
0
Kuala Lumpur
Query!
Country [215]
0
0
Malaysia
Query!
State/province [215]
0
0
Pahang
Query!
Country [216]
0
0
Malaysia
Query!
State/province [216]
0
0
Selangor Darul Ehsan
Query!
Country [217]
0
0
Malaysia
Query!
State/province [217]
0
0
Selangor
Query!
Country [218]
0
0
Mexico
Query!
State/province [218]
0
0
Colonia Americana
Query!
Country [219]
0
0
Mexico
Query!
State/province [219]
0
0
Distrito Federal
Query!
Country [220]
0
0
Mexico
Query!
State/province [220]
0
0
Ladron de Guevara
Query!
Country [221]
0
0
Mexico
Query!
State/province [221]
0
0
Los Robles
Query!
Country [222]
0
0
Mexico
Query!
State/province [222]
0
0
Monterrey
Query!
Country [223]
0
0
Mexico
Query!
State/province [223]
0
0
Reforma Social
Query!
Country [224]
0
0
Mexico
Query!
State/province [224]
0
0
San Lucas tepetlcalco
Query!
Country [225]
0
0
Netherlands
Query!
State/province [225]
0
0
Amersfoort
Query!
Country [226]
0
0
Netherlands
Query!
State/province [226]
0
0
Apeldoorn
Query!
Country [227]
0
0
Netherlands
Query!
State/province [227]
0
0
Baarle - Nassau
Query!
Country [228]
0
0
Netherlands
Query!
State/province [228]
0
0
Delft
Query!
Country [229]
0
0
Netherlands
Query!
State/province [229]
0
0
Den Helder
Query!
Country [230]
0
0
Netherlands
Query!
State/province [230]
0
0
Geleen
Query!
Country [231]
0
0
Netherlands
Query!
State/province [231]
0
0
Hardenberg
Query!
Country [232]
0
0
Netherlands
Query!
State/province [232]
0
0
Heerlen
Query!
Country [233]
0
0
Netherlands
Query!
State/province [233]
0
0
Hoogeveen
Query!
Country [234]
0
0
Netherlands
Query!
State/province [234]
0
0
Hoogezand
Query!
Country [235]
0
0
Netherlands
Query!
State/province [235]
0
0
Hoogwoud
Query!
Country [236]
0
0
Netherlands
Query!
State/province [236]
0
0
Maastricht
Query!
Country [237]
0
0
Netherlands
Query!
State/province [237]
0
0
Meppel
Query!
Country [238]
0
0
Netherlands
Query!
State/province [238]
0
0
Nijverdal
Query!
Country [239]
0
0
Netherlands
Query!
State/province [239]
0
0
Rotterdam
Query!
Country [240]
0
0
Netherlands
Query!
State/province [240]
0
0
Schiedam
Query!
Country [241]
0
0
Netherlands
Query!
State/province [241]
0
0
Utrecht
Query!
Country [242]
0
0
Netherlands
Query!
State/province [242]
0
0
Wildervank
Query!
Country [243]
0
0
Netherlands
Query!
State/province [243]
0
0
Zutphen
Query!
Country [244]
0
0
New Zealand
Query!
State/province [244]
0
0
Christchurch
Query!
Country [245]
0
0
New Zealand
Query!
State/province [245]
0
0
Grafton / Auckland
Query!
Country [246]
0
0
New Zealand
Query!
State/province [246]
0
0
Wellington
Query!
Country [247]
0
0
Norway
Query!
State/province [247]
0
0
Fornebu
Query!
Country [248]
0
0
Norway
Query!
State/province [248]
0
0
Gjøvik
Query!
Country [249]
0
0
Norway
Query!
State/province [249]
0
0
Kløfta
Query!
Country [250]
0
0
Norway
Query!
State/province [250]
0
0
Kongsvinger
Query!
Country [251]
0
0
Norway
Query!
State/province [251]
0
0
Oslo
Query!
Country [252]
0
0
Norway
Query!
State/province [252]
0
0
Trondheim
Query!
Country [253]
0
0
Norway
Query!
State/province [253]
0
0
Tynset
Query!
Country [254]
0
0
Peru
Query!
State/province [254]
0
0
Arequipa
Query!
Country [255]
0
0
Peru
Query!
State/province [255]
0
0
Bellavista
Query!
Country [256]
0
0
Peru
Query!
State/province [256]
0
0
El Agustino
Query!
Country [257]
0
0
Peru
Query!
State/province [257]
0
0
Ica
Query!
Country [258]
0
0
Peru
Query!
State/province [258]
0
0
Jesus Maria
Query!
Country [259]
0
0
Peru
Query!
State/province [259]
0
0
Lima
Query!
Country [260]
0
0
Peru
Query!
State/province [260]
0
0
Miraflores
Query!
Country [261]
0
0
Philippines
Query!
State/province [261]
0
0
Cavite City
Query!
Country [262]
0
0
Philippines
Query!
State/province [262]
0
0
Cebu
Query!
Country [263]
0
0
Philippines
Query!
State/province [263]
0
0
Davao
Query!
Country [264]
0
0
Philippines
Query!
State/province [264]
0
0
Jaro Iloilo City
Query!
Country [265]
0
0
Philippines
Query!
State/province [265]
0
0
Manila
Query!
Country [266]
0
0
Philippines
Query!
State/province [266]
0
0
Marikina City
Query!
Country [267]
0
0
Philippines
Query!
State/province [267]
0
0
Tarlac
Query!
Country [268]
0
0
Poland
Query!
State/province [268]
0
0
Gdansk
Query!
Country [269]
0
0
Poland
Query!
State/province [269]
0
0
Lodz
Query!
Country [270]
0
0
Poland
Query!
State/province [270]
0
0
Lublin
Query!
Country [271]
0
0
Poland
Query!
State/province [271]
0
0
Oswiecim
Query!
Country [272]
0
0
Poland
Query!
State/province [272]
0
0
Poznan
Query!
Country [273]
0
0
Poland
Query!
State/province [273]
0
0
Pulawy
Query!
Country [274]
0
0
Poland
Query!
State/province [274]
0
0
Ruda Slaska
Query!
Country [275]
0
0
Poland
Query!
State/province [275]
0
0
Torun
Query!
Country [276]
0
0
Portugal
Query!
State/province [276]
0
0
Amadora
Query!
Country [277]
0
0
Portugal
Query!
State/province [277]
0
0
Coimbra
Query!
Country [278]
0
0
Portugal
Query!
State/province [278]
0
0
Faro
Query!
Country [279]
0
0
Portugal
Query!
State/province [279]
0
0
Funchal
Query!
Country [280]
0
0
Portugal
Query!
State/province [280]
0
0
Leiria
Query!
Country [281]
0
0
Portugal
Query!
State/province [281]
0
0
Lisboa
Query!
Country [282]
0
0
Portugal
Query!
State/province [282]
0
0
Porto
Query!
Country [283]
0
0
Portugal
Query!
State/province [283]
0
0
Santiago do Cacém
Query!
Country [284]
0
0
Portugal
Query!
State/province [284]
0
0
Torres Novas
Query!
Country [285]
0
0
Portugal
Query!
State/province [285]
0
0
Viana do Castelo
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Funding & Sponsors
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Name
Boehringer Ingelheim
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Eli Lilly and Company
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Summary
Brief summary
The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.
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Trial website
https://clinicaltrials.gov/study/NCT01131676
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Trial related presentations / publications
Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034. Kahl S, Ofstad AP, Zinman B, Wanner C, Schuler E, Sattar N, Inzucchi SE, Roden M. Effects of empagliflozin on markers of liver steatosis and fibrosis and their relationship to cardiorenal outcomes. Diabetes Obes Metab. 2022 Jun;24(6):1061-1071. doi: 10.1111/dom.14670. Epub 2022 Mar 8. Ruggenenti P, Kraus BJ, Inzucchi SE, Zinman B, Hantel S, Mattheus M, von Eynatten M, Remuzzi G, Koitka-Weber A, Wanner C. Nephrotic-range proteinuria in type 2 diabetes: Effects of empagliflozin on kidney disease progression and clinical outcomes. EClinicalMedicine. 2021 Dec 24;43:101240. doi: 10.1016/j.eclinm.2021.101240. eCollection 2022 Jan. Reifsnider OS, Kansal AR, Wanner C, Pfarr E, Koitka-Weber A, Brand SB, Stargardter M, Wang C, Kuti E, Ustyugova A. Cost-Effectiveness of Empagliflozin in Patients With Diabetic Kidney Disease in the United States: Findings Based on the EMPA-REG OUTCOME Trial. Am J Kidney Dis. 2022 Jun;79(6):796-806. doi: 10.1053/j.ajkd.2021.09.014. Epub 2021 Nov 6. Ferreira JP, Inzucchi SE, Mattheus M, Meinicke T, Steubl D, Wanner C, Zinman B. Empagliflozin and uric acid metabolism in diabetes: A post hoc analysis of the EMPA-REG OUTCOME trial. Diabetes Obes Metab. 2022 Jan;24(1):135-141. doi: 10.1111/dom.14559. Epub 2021 Oct 4. Vaduganathan M, Inzucchi SE, Sattar N, Fitchett DH, Ofstad AP, Brueckmann M, George JT, Verma S, Mattheus M, Wanner C, Zinman B, Butler J. Effects of empagliflozin on insulin initiation or intensification in patients with type 2 diabetes and cardiovascular disease: Findings from the EMPA-REG OUTCOME trial. Diabetes Obes Metab. 2021 Dec;23(12):2775-2784. doi: 10.1111/dom.14535. Epub 2021 Oct 7. Sharma A, Ofstad AP, Ahmad T, Zinman B, Zwiener I, Fitchett D, Wanner C, George JT, Hantel S, Desai N, Mentz RJ. Patient Phenotypes and SGLT-2 Inhibition in Type 2 Diabetes: Insights From the EMPA-REG OUTCOME Trial. JACC Heart Fail. 2021 Aug;9(8):568-577. doi: 10.1016/j.jchf.2021.03.003. Cherney DZI, Dagogo-Jack S, McGuire DK, Cosentino F, Pratley R, Shih WJ, Frederich R, Maldonado M, Liu J, Wang S, Cannon CP; VERTIS CV Investigators. Kidney outcomes using a sustained >/=40% decline in eGFR: A meta-analysis of SGLT2 inhibitor trials. Clin Cardiol. 2021 Aug;44(8):1139-1143. doi: 10.1002/clc.23665. Epub 2021 Jun 15. Ferreira JP, Kraus BJ, Zwiener I, Lauer S, Zinman B, Fitchett DH, Koitka-Weber A, George JT, Ofstad AP, Wanner C, Zannad F. Cardio/Kidney Composite End Points: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial. J Am Heart Assoc. 2021 Apr 6;10(7):e020053. doi: 10.1161/JAHA.120.020053. Epub 2021 Mar 23. Ferreira JP, Verma S, Fitchett D, Ofstad AP, Lauer S, Zwiener I, George J, Wanner C, Zinman B, Inzucchi SE. Metabolic syndrome in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a post hoc analyses of the EMPA-REG OUTCOME trial. Cardiovasc Diabetol. 2020 Nov 26;19(1):200. doi: 10.1186/s12933-020-01174-6. McGuire DK, Zinman B, Inzucchi SE, Wanner C, Fitchett D, Anker SD, Pocock S, Kaspers S, George JT, von Eynatten M, Johansen OE, Jamal W, Mattheus M, Elsasser U, Hantel S, Lund SS. Effects of empagliflozin on first and recurrent clinical events in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a secondary analysis of the EMPA-REG OUTCOME trial. Lancet Diabetes Endocrinol. 2020 Dec;8(12):949-959. doi: 10.1016/S2213-8587(20)30344-2. Ceriello A, Ofstad AP, Zwiener I, Kaspers S, George J, Nicolucci A. Empagliflozin reduced long-term HbA1c variability and cardiovascular death: insights from the EMPA-REG OUTCOME trial. Cardiovasc Diabetol. 2020 Oct 13;19(1):176. doi: 10.1186/s12933-020-01147-9. Neeland IJ, Eliasson B, Kasai T, Marx N, Zinman B, Inzucchi SE, Wanner C, Zwiener I, Wojeck BS, Yaggi HK, Johansen OE; EMPA-REG OUTCOME Investigators. The Impact of Empagliflozin on Obstructive Sleep Apnea and Cardiovascular and Renal Outcomes: An Exploratory Analysis of the EMPA-REG OUTCOME Trial. Diabetes Care. 2020 Dec;43(12):3007-3015. doi: 10.2337/dc20-1096. Epub 2020 Oct 1. Levin A, Perkovic V, Wheeler DC, Hantel S, George JT, von Eynatten M, Koitka-Weber A, Wanner C; EMPA-REG OUTCOME Investigators. Empagliflozin and Cardiovascular and Kidney Outcomes across KDIGO Risk Categories: Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled, Multinational Trial. Clin J Am Soc Nephrol. 2020 Oct 7;15(10):1433-1444. doi: 10.2215/CJN.14901219. Epub 2020 Sep 29. Waijer SW, Xie D, Inzucchi SE, Zinman B, Koitka-Weber A, Mattheus M, von Eynatten M, Inker LA, Wanner C, Heerspink HJL. Short-Term Changes in Albuminuria and Risk of Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial. J Am Heart Assoc. 2020 Sep 15;9(18):e016976. doi: 10.1161/JAHA.120.016976. Epub 2020 Sep 6. Bohm M, Fitchett D, Ofstad AP, Brueckmann M, Kaspers S, George JT, Zwiener I, Zinman B, Wanner C, Marx N, Mancia G, Anker SD, Mahfoud F. Heart failure and renal outcomes according to baseline and achieved blood pressure in patients with type 2 diabetes: results from EMPA-REG OUTCOME. J Hypertens. 2020 Sep;38(9):1829-1840. doi: 10.1097/HJH.0000000000002492. Inzucchi SE, Khunti K, Fitchett DH, Wanner C, Mattheus M, George JT, Ofstad AP, Zinman B. Cardiovascular Benefit of Empagliflozin Across the Spectrum of Cardiovascular Risk Factor Control in the EMPA-REG OUTCOME Trial. J Clin Endocrinol Metab. 2020 Sep 1;105(9):3025-35. doi: 10.1210/clinem/dgaa321. Ferreira JP, Fitchett D, Ofstad AP, Kraus BJ, Wanner C, Zwiener I, Zinman B, Lauer S, George JT, Rossignol P, Zannad F. Empagliflozin for Patients With Presumed Resistant Hypertension: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial. Am J Hypertens. 2020 Dec 31;33(12):1092-1101. doi: 10.1093/ajh/hpaa073. Perkovic V, Koitka-Weber A, Cooper ME, Schernthaner G, Pfarr E, Woerle HJ, von Eynatten M, Wanner C. Choice of endpoint in kidney outcome trials: considerations from the EMPA-REG OUTCOME(R) trial. Nephrol Dial Transplant. 2020 Dec 4;35(12):2103-2111. doi: 10.1093/ndt/gfz179. Kansal A, Reifsnider OS, Proskorovsky I, Zheng Y, Pfarr E, George JT, Kandaswamy P, Ruffolo A. Cost-effectiveness analysis of empagliflozin treatment in people with Type 2 diabetes and established cardiovascular disease in the EMPA-REG OUTCOME trial. Diabet Med. 2019 Nov;36(11):1494-1502. doi: 10.1111/dme.14076. Epub 2019 Jul 23. Butler J, Zannad F, Fitchett D, Zinman B, Koitka-Weber A, von Eynatten M, Zwiener I, George J, Brueckmann M, Cheung AK, Wanner C. Empagliflozin Improves Kidney Outcomes in Patients With or Without Heart Failure. Circ Heart Fail. 2019 Jun;12(6):e005875. doi: 10.1161/CIRCHEARTFAILURE.118.005875. Epub 2019 Jun 5. Verma S, Wanner C, Zwiener I, Ofstad AP, George JT, Fitchett D, Zinman B; EMPA-REG OUTCOME Investigators. Influence of Microvascular Disease on Cardiovascular Events in Type 2 Diabetes. J Am Coll Cardiol. 2019 Jun 4;73(21):2780-2782. doi: 10.1016/j.jacc.2019.03.002. Epub 2019 Mar 15. No abstract available. Januzzi J, Ferreira JP, Bohm M, Kaul S, Wanner C, Brueckmann M, Petrie MC, Ofstad AP, Zeller C, George J, Fitchett D, Zannad F. Empagliflozin reduces the risk of a broad spectrum of heart failure outcomes regardless of heart failure status at baseline. Eur J Heart Fail. 2019 Mar;21(3):386-388. doi: 10.1002/ejhf.1419. Epub 2019 Feb 14. No abstract available. Fitchett D, Inzucchi SE, Cannon CP, McGuire DK, Scirica BM, Johansen OE, Sambevski S, Kaspers S, Pfarr E, George JT, Zinman B. Empagliflozin Reduced Mortality and Hospitalization for Heart Failure Across the Spectrum of Cardiovascular Risk in the EMPA-REG OUTCOME Trial. Circulation. 2019 Mar 12;139(11):1384-1395. doi: 10.1161/CIRCULATIONAHA.118.037778. Verma S, Mazer CD, Fitchett D, Inzucchi SE, Pfarr E, George JT, Zinman B. Empagliflozin reduces cardiovascular events, mortality and renal events in participants with type 2 diabetes after coronary artery bypass graft surgery: subanalysis of the EMPA-REG OUTCOME(R) randomised trial. Diabetologia. 2018 Aug;61(8):1712-1723. doi: 10.1007/s00125-018-4644-9. Epub 2018 May 19. Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Eligibility varies among the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials: implications for the general type 2 diabetes US population. Am J Manag Care. 2018 Apr;24(8 Suppl):S138-S145. Inzucchi SE, Zinman B, Fitchett D, Wanner C, Ferrannini E, Schumacher M, Schmoor C, Ohneberg K, Johansen OE, George JT, Hantel S, Bluhmki E, Lachin JM. How Does Empagliflozin Reduce Cardiovascular Mortality? Insights From a Mediation Analysis of the EMPA-REG OUTCOME Trial. Diabetes Care. 2018 Feb;41(2):356-363. doi: 10.2337/dc17-1096. Epub 2017 Dec 4. Wanner C, Lachin JM, Inzucchi SE, Fitchett D, Mattheus M, George J, Woerle HJ, Broedl UC, von Eynatten M, Zinman B; EMPA-REG OUTCOME Investigators. Empagliflozin and Clinical Outcomes in Patients With Type 2 Diabetes Mellitus, Established Cardiovascular Disease, and Chronic Kidney Disease. Circulation. 2018 Jan 9;137(2):119-129. doi: 10.1161/CIRCULATIONAHA.117.028268. Epub 2017 Sep 13. Cherney DZI, Zinman B, Inzucchi SE, Koitka-Weber A, Mattheus M, von Eynatten M, Wanner C. Effects of empagliflozin on the urinary albumin-to-creatinine ratio in patients with type 2 diabetes and established cardiovascular disease: an exploratory analysis from the EMPA-REG OUTCOME randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2017 Aug;5(8):610-621. doi: 10.1016/S2213-8587(17)30182-1. Epub 2017 Jun 27. Zinman B, Inzucchi SE, Lachin JM, Wanner C, Fitchett D, Kohler S, Mattheus M, Woerle HJ, Broedl UC, Johansen OE, Albers GW, Diener HC; EMPA-REG OUTCOME Investigators (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients). Empagliflozin and Cerebrovascular Events in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk. Stroke. 2017 May;48(5):1218-1225. doi: 10.1161/STROKEAHA.116.015756. Epub 2017 Apr 6. Wanner C, Inzucchi SE, Lachin JM, Fitchett D, von Eynatten M, Mattheus M, Johansen OE, Woerle HJ, Broedl UC, Zinman B; EMPA-REG OUTCOME Investigators. Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):323-34. doi: 10.1056/NEJMoa1515920. Epub 2016 Jun 14. Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17. Zinman B, Inzucchi SE, Lachin JM, Wanner C, Ferrari R, Fitchett D, Bluhmki E, Hantel S, Kempthorne-Rawson J, Newman J, Johansen OE, Woerle HJ, Broedl UC. Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME). Cardiovasc Diabetol. 2014 Jun 19;13:102. doi: 10.1186/1475-2840-13-102.
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Public notes
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Contacts
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Boehringer Ingelheim
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Boehringer Ingelheim
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Results are available at
https://clinicaltrials.gov/study/NCT01131676
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