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BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).

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ClinicalTrials.gov Identifier: NCT01131676
Recruitment Status : Completed
First Posted : May 27, 2010
Results First Posted : May 16, 2016
Last Update Posted : May 16, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: BI 10773 low dose
Drug: Placebo BI 10773 high dose
Drug: BI 10773 high dose
Drug: Placebo BI 10773 low dose

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients randomised to treatments in 1:1:1 ratio.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomisation stratified by:BMI at randomisation(<30/≥30 kg/m2),HbA1c at screening (<8.5%/ ≥8.5%);geographical region(North America including Australia and New Zealand,Latin America,Europe,Africa,Asia);renal function at screening (normal:eGFR ≥90 mL/min, mild impairment:60 mL/min ≤ eGFR ≤89 mL/min, moderate impairment:30 mL/min ≤ eGFR≤59 mL/min).

Reporting Groups
  Description
Placebo Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
Empagliflozin 10 mg Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
Empagliflozin 25 mg Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)

Participant Flow for 2 periods

 Period 1:   Discontinuation From Treatment
    Placebo   Empagliflozin 10 mg   Empagliflozin 25 mg
STARTED   2337 [1]   2347 [1]   2344 [1] 
COMPLETED   1650 [2]   1790 [2]   1800 [2] 
NOT COMPLETED   687   557   544 
Study drug stopped, reason missing                5                3                4 
Not treated                4                2                2 
Lack of Efficacy                11                1                0 
Non compliant with protocol                15                15                12 
Lost to Follow-up                15                9                6 
Refusal to continue, not due to AE                172                118                122 
Other than those specified                162                142                125 
Adverse Event                303                267                273 
[1] Randomised
[2] Not prematurely discontinued from trial medication

Period 2:   Discontinuation From Study (Treated Set)
    Placebo   Empagliflozin 10 mg   Empagliflozin 25 mg
STARTED   2333   2345   2342 
Final Vital Status (VS) Available   2316   2324   2327 
COMPLETED   2266 [1]   2264 [1]   2279 [1] 
NOT COMPLETED   67   81   63 
Consent withdrawn: Final VS available                23                35                25 
Consent withdrawn:Final VS not available                8                6                5 
Site closure: Final VS available                20                21                19 
Site closure:Final VS not available (NA)                5                9                7 
Lost to FU for 3PMACE:Final VS available                7                6                5 
Lost to FU for 3P-MACE:Final VS NA                4                4                2 
[1] Completed the trial or died



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set (TS): Consists of all randomised patients who received at least 1 dose of study medication. Patients were assigned to treatment groups according to the randomisation scheme.

Reporting Groups
  Description
Placebo Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
Empagliflozin 10 mg Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
Empagliflozin 25 mg Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
Total Total of all reporting groups

Baseline Measures
   Placebo   Empagliflozin 10 mg   Empagliflozin 25 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 2333   2345   2342   7020 
Age 
[Units: Years]
Mean (Standard Deviation) 		 63.2  (8.8)   63.0  (8.6)   63.2  (8.6)   63.1  (8.6) 
Gender 
[Units: Participants]
 		       
Female   653   692   659   2004 
Male   1680   1653   1683   5016 


  Outcome Measures

1.  Primary:   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.   [ Time Frame: From randomisation to individual end of observation, up to 4.6 years ]
  Show Outcome Measure 1

2.  Secondary:   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   [ Time Frame: From randomisation to individual end of observation, up to 4.6 years ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants With Silent MI   [ Time Frame: From randomisation to individual end of observation, up to 4.6 years ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants With Heart Failure Requiring Hospitalisation (Adjudicated)   [ Time Frame: From randomisation to individual end of observation, up to 4.6 years ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Participants With New Onset Albuminuria   [ Time Frame: From randomisation to individual end of observation, up to 4.6 years ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants With New Onset Macroalbuminuria   [ Time Frame: From randomisation to individual end of observation, up to 4.6 years ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Participants With the Composite Microvascular Outcome   [ Time Frame: From randomisation to individual end of observation, up to 4.6 years ]
  Show Outcome Measure 7


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
2 sets of duplicates(4 patients(pts)) were counted only once.652 sites were initiated and 611 enrolled.One site transferred all pts to other sites.27 pts randomised and 13 pts screened were excluded from analyses due to serious non-compliance


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
phone: 800-243-0127 ext +1
e-mail: clintriage.rdg@boehringer-ingelheim.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01131676     History of Changes
Other Study ID Numbers: 1245.25
2009-016178-33 ( EudraCT Number: EudraCT )
First Submitted: May 26, 2010
First Posted: May 27, 2010
Results First Submitted: April 7, 2016
Results First Posted: May 16, 2016
Last Update Posted: May 16, 2016