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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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).
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
Secondary ID [1] 0 0
2009-016178-33
Secondary ID [2] 0 0
1245.25
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
From randomisation to individual end of observation, up to 4.6 years
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
From randomisation to individual end of observation, up to 4.6 years
Secondary outcome [2] 0 0
Percentage of Participants With Silent MI
Timepoint [2] 0 0
From randomisation to individual end of observation, up to 4.6 years
Secondary outcome [3] 0 0
Percentage of Participants With Heart Failure Requiring Hospitalisation (Adjudicated)
Timepoint [3] 0 0
From randomisation to individual end of observation, up to 4.6 years
Secondary outcome [4] 0 0
Percentage of Participants With New Onset Albuminuria
Timepoint [4] 0 0
From randomisation to individual end of observation, up to 4.6 years
Secondary outcome [5] 0 0
Percentage of Participants With New Onset Macroalbuminuria
Timepoint [5] 0 0
From randomisation to individual end of observation, up to 4.6 years
Secondary outcome [6] 0 0
Percentage of Participants With the Composite Microvascular Outcome
Timepoint [6] 0 0
From randomisation to individual end of observation, up to 4.6 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
7064
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
1245.25.61003 Boehringer Ingelheim Investigational Site - Herston
Recruitment hospital [2] 0 0
1245.25.61001 Boehringer Ingelheim Investigational Site - Ashford
Recruitment hospital [3] 0 0
1245.25.61002 Boehringer Ingelheim Investigational Site - Fullarton
Recruitment postcode(s) [1] 0 0
- Herston
Recruitment postcode(s) [2] 0 0
- Ashford
Recruitment postcode(s) [3] 0 0
- Fullarton
Recruitment outside Australia
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Equeurdreville Haineville
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Grenoble
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La Rochelle Cedex 1
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Pessac
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Poitiers
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Tours
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Batumi
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Kutaisi
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Tbilisi
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Greece
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Athens
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Larissa
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Greece
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Nikaia
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Greece
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Thessaloniki
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Hong Kong
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Budapest
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India
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India
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Jalandhar
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India
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Nagpur
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India
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Nashik, Maharashtra
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Pune
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Vijaywada
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Indonesia
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Denpasar, Bali
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Malang
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Yogyakarta
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Israel
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Israel
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Hadera
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Haifa
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Holon
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Israel
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Pisa
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Roma
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Hanyushi, Saitama
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Kishiwadashi. Osaka
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Kita-ku, Nagoyashi, Aichi
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Kumamoto-shi, Kumamoto
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Matsudoshi, Chiba
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Japan
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Mitoshi, Ibaraki
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Nishi-ku, Sapporoshi, Hokkaido
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Nodashi, Chiba
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Shimajiri-gun,Okinawa
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Toyamashi, Toyama
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Japan
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Toyoakeshi, Aichi
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Daejeon
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01131676
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01131676