ClinicalTrials.gov record
BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).
ClinicalTrials.gov ID: NCT01131676
Public ClinicalTrials.gov record NCT01131676. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01131676
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 7,064 participants
Conditions and interventions
Conditions
Interventions
- BI 10773 low dose Drug
- Placebo BI 10773 high dose Drug
- BI 10773 high dose Drug
- Placebo BI 10773 low dose Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2010
- Primary completion
- Mar 31, 2015
- Completion
- Mar 31, 2015
- Last update posted
- May 15, 2016
2010 – 2015
United States locations
- U.S. sites
- 170
- U.S. states
- 42
- U.S. cities
- 143
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1245.25.10043 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | — | — |
| 1245.25.10121 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | — | — |
| 1245.25.10037 Boehringer Ingelheim Investigational Site | Huntsville | Alabama | — | — |
| 1245.25.10124 Boehringer Ingelheim Investigational Site | Mobile | Alabama | — | — |
| 1245.25.10015 Boehringer Ingelheim Investigational Site | Little Rock | Alaska | — | — |
| 1245.25.10056 Boehringer Ingelheim Investigational Site | Gilbert | Arizona | — | — |
| 1245.25.10175 Boehringer Ingelheim Investigational Site | Peoria | Arizona | — | — |
| 1245.25.10072 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | — | — |
| 1245.25.10048 Boehringer Ingelheim Investigational Site | Harrisburg | Arkansas | — | — |
| 1245.25.10035 Boehringer Ingelheim Investigational Site | Anaheim | California | — | — |
| 1245.25.10103 Boehringer Ingelheim Investigational Site | Encino | California | — | — |
| 1245.25.10158 Boehringer Ingelheim Investigational Site | Fresno | California | — | — |
| 1245.25.10126 Boehringer Ingelheim Investigational Site | Harbor City | California | — | — |
| 1245.25.10058 Boehringer Ingelheim Investigational Site | Huntington Park | California | — | — |
| 1245.25.10001 Boehringer Ingelheim Investigational Site | Lancaster | California | — | — |
| 1245.25.10102 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1245.25.10047 Boehringer Ingelheim Investigational Site | Los Gatos | California | — | — |
| 1245.25.10118 Boehringer Ingelheim Investigational Site | Palm Springs | California | — | — |
| 1245.25.10061 Boehringer Ingelheim Investigational Site | Riverside | California | — | — |
| 1245.25.10040 Boehringer Ingelheim Investigational Site | San Diego | California | — | — |
| 1245.25.10055 Boehringer Ingelheim Investigational Site | San Diego | California | — | — |
| 1245.25.10193 Boehringer Ingelheim Investigational Site | San Diego | California | — | — |
| 1245.25.10027 Boehringer Ingelheim Investigational Site | Santa Rosa | California | — | — |
| 1245.25.10074 Boehringer Ingelheim Investigational Site | Stockton | California | — | — |
| 1245.25.10083 Boehringer Ingelheim Investigational Site | Valencia | California | — | — |
| 1245.25.10144 Boehringer Ingelheim Investigational Site | Colorado Springs | Colorado | — | — |
| 1245.25.10085 Boehringer Ingelheim Investigational Site | Denver | Colorado | — | — |
| 1245.25.10153 Boehringer Ingelheim Investigational Site | Denver | Colorado | — | — |
| 1245.25.10066 Boehringer Ingelheim Investigational Site | Norwalk | Connecticut | — | — |
| 1245.25.10038 Boehringer Ingelheim Investigational Site | Waterbury | Connecticut | — | — |
| 1245.25.10068 Boehringer Ingelheim Investigational Site | Washington D.C. | District of Columbia | — | — |
| 1245.25.10094 Boehringer Ingelheim Investigational Site | Bradenton | Florida | — | — |
| 1245.25.10190 Boehringer Ingelheim Investigational Site | Brooksville | Florida | — | — |
| 1245.25.10209 Boehringer Ingelheim Investigational Site | Clearwater | Florida | — | — |
| 1245.25.10212 Boehringer Ingelheim Investigational Site | Cooper City | Florida | — | — |
| 1245.25.10200 Boehringer Ingelheim Investigational Site | Delray Beach | Florida | — | — |
| 1245.25.10033 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | — | — |
| 1245.25.10202 Boehringer Ingelheim Investigational Site | Hallandale | Florida | — | — |
| 1245.25.10062 Boehringer Ingelheim Investigational Site | Hialeah | Florida | — | — |
| 1245.25.10063 Boehringer Ingelheim Investigational Site | Hialeah | Florida | — | — |
| 1245.25.10157 Boehringer Ingelheim Investigational Site | Hialeah | Florida | — | — |
| 1245.25.10089 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | — | — |
| 1245.25.10019 Boehringer Ingelheim Investigational Site | Longwood | Florida | — | — |
| 1245.25.10168 Boehringer Ingelheim Investigational Site | Maitland | Florida | — | — |
| 1245.25.10018 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1245.25.10039 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1245.25.10184 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1245.25.10123 Boehringer Ingelheim Investigational Site | Orlando | Florida | — | — |
| 1245.25.10201 Boehringer Ingelheim Investigational Site | Orlando | Florida | — | — |
| 1245.25.10025 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | — | — |
| 1245.25.10042 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | — | — |
| 1245.25.10147 Boehringer Ingelheim Investigational Site | Port Charlotte | Florida | — | — |
| 1245.25.10198 Boehringer Ingelheim Investigational Site | St. Petersburg | Florida | — | — |
| 1245.25.10203 Boehringer Ingelheim Investigational Site | St. Petersburg | Florida | — | — |
| 1245.25.10104 Boehringer Ingelheim Investigational Site | Tampa | Florida | — | — |
| 1245.25.10178 Boehringer Ingelheim Investigational Site | Tampa | Florida | — | — |
| 1245.25.10211 Boehringer Ingelheim Investigational Site | Tampa | Florida | — | — |
| 1245.25.10023 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | — | — |
| 1245.25.10174 Boehringer Ingelheim Investigational Site | Columbus | Georgia | — | — |
| 1245.25.10141 Boehringer Ingelheim Investigational Site | Riverdale | Georgia | — | — |
| 1245.25.10067 Boehringer Ingelheim Investigational Site | Roswell | Georgia | — | — |
| 1245.25.10022 Boehringer Ingelheim Investigational Site | Honolulu | Hawaii | — | — |
| 1245.25.10092 Boehringer Ingelheim Investigational Site | Boise | Idaho | — | — |
| 1245.25.10097 Boehringer Ingelheim Investigational Site | Chicago | Illinois | — | — |
| 1245.25.10116 Boehringer Ingelheim Investigational Site | Evansville | Indiana | — | — |
| 1245.25.10206 Boehringer Ingelheim Investigational Site | Valparaiso | Indiana | — | — |
| 1245.25.10021 Boehringer Ingelheim Investigational Site | Wichita | Kansas | — | — |
| 1245.25.10186 Boehringer Ingelheim Investigational Site | Lexington | Kentucky | — | — |
| 1245.25.10109 Boehringer Ingelheim Investigational Site | Louisville | Kentucky | — | — |
| 1245.25.10006 Boehringer Ingelheim Investigational Site | Madisonville | Kentucky | — | — |
| 1245.25.10005 Boehringer Ingelheim Investigational Site | Paducah | Kentucky | — | — |
| 1245.25.10020 Boehringer Ingelheim Investigational Site | New Orleans | Louisiana | — | — |
| 1245.25.10012 Boehringer Ingelheim Investigational Site | Auburn | Maine | — | — |
| 1245.25.10041 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | — | — |
| 1245.25.10134 Boehringer Ingelheim Investigational Site | Hyattsville | Maryland | — | — |
| 1245.25.10210 Boehringer Ingelheim Investigational Site | Towson | Maryland | — | — |
| 1245.25.10064 Boehringer Ingelheim Investigational Site | Springfield | Massachusetts | — | — |
| 1245.25.10051 Boehringer Ingelheim Investigational Site | Watertown | Massachusetts | — | — |
| 1245.25.10071 Boehringer Ingelheim Investigational Site | Dearborn | Michigan | — | — |
| 1245.25.10013 Boehringer Ingelheim Investigational Site | Flint | Michigan | — | — |
| 1245.25.10107 Boehringer Ingelheim Investigational Site | Petoskey | Michigan | — | — |
| 1245.25.10030 Boehringer Ingelheim Investigational Site | Eagan | Minnesota | — | — |
| 1245.25.10028 Boehringer Ingelheim Investigational Site | Minneapolis | Minnesota | — | — |
| 1245.25.10176 Boehringer Ingelheim Investigational Site | Picayune | Mississippi | — | — |
| 1245.25.10011 Boehringer Ingelheim Investigational Site | Chesterfield | Missouri | — | — |
| 1245.25.10163 Boehringer Ingelheim Investigational Site | Kansas City | Missouri | — | — |
| 1245.25.10148 Boehringer Ingelheim Investigational Site | Great Falls | Montana | — | — |
| 1245.25.10191 Boehringer Ingelheim Investigational Site | Great Falls | Montana | — | — |
| 1245.25.10034 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | — | — |
| 1245.25.10014 Boehringer Ingelheim Investigational Site | Flemington | New Jersey | — | — |
| 1245.25.10145 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | — | — |
| 1245.25.10180 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | — | — |
| 1245.25.10131 Boehringer Ingelheim Investigational Site | Binghamton | New York | — | — |
| 1245.25.10029 Boehringer Ingelheim Investigational Site | Rochester | New York | — | — |
| 1245.25.10142 Boehringer Ingelheim Investigational Site | Smithtown | New York | — | — |
| 1245.25.10096 Boehringer Ingelheim Investigational Site | Staten Island | New York | — | — |
| 1245.25.10196 Boehringer Ingelheim Investigational Site | Burlington | North Carolina | — | — |
| 1245.25.10207 Boehringer Ingelheim Investigational Site | Calabash | North Carolina | — | — |
| 1245.25.10053 Boehringer Ingelheim Investigational Site | Durham | North Carolina | — | — |
| 1245.25.10010 Boehringer Ingelheim Investigational Site | Greenville | North Carolina | — | — |
| 1245.25.10060 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | — | — |
| 1245.25.10086 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | — | — |
| 1245.25.10137 Boehringer Ingelheim Investigational Site | Dayton | Ohio | — | — |
| 1245.25.10138 Boehringer Ingelheim Investigational Site | Delaware | Ohio | — | — |
| 1245.25.10156 Boehringer Ingelheim Investigational Site | Kettering | Ohio | — | — |
| 1245.25.10091 Boehringer Ingelheim Investigational Site | Marion | Ohio | — | — |
| 1245.25.10192 Boehringer Ingelheim Investigational Site | Zanesville | Ohio | — | — |
| 1245.25.10114 Boehringer Ingelheim Investigational Site | Norman | Oklahoma | — | — |
| 1245.25.10082 Boehringer Ingelheim Investigational Site | Eugene | Oregon | — | — |
| 1245.25.10154 Boehringer Ingelheim Investigational Site | Clairton | Pennsylvania | — | — |
| 1245.25.10173 Boehringer Ingelheim Investigational Site | Clairton | Pennsylvania | — | — |
| 1245.25.10052 Boehringer Ingelheim Investigational Site | Feasterville-Trevose | Pennsylvania | — | — |
| 1245.25.10069 Boehringer Ingelheim Investigational Site | Fleetwood | Pennsylvania | — | — |
| 1245.25.10172 Boehringer Ingelheim Investigational Site | Greensburg | Pennsylvania | — | — |
| 1245.25.10050 Boehringer Ingelheim Investigational Site | Indiana | Pennsylvania | — | — |
| 1245.25.10009 Boehringer Ingelheim Investigational Site | Lansdale | Pennsylvania | — | — |
| 1245.25.10214 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | — | — |
| 1245.25.10149 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | — | — |
| 1245.25.10197 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | — | — |
| 1245.25.10159 Boehringer Ingelheim Investigational Site | Scottdale | Pennsylvania | — | — |
| 1245.25.10162 Boehringer Ingelheim Investigational Site | Tipton | Pennsylvania | — | — |
| 1245.25.10146 Boehringer Ingelheim Investigational Site | Uniontown | Pennsylvania | — | — |
| 1245.25.10077 Boehringer Ingelheim Investigational Site | Yardley | Pennsylvania | — | — |
| 1245.25.10070 Boehringer Ingelheim Investigational Site | Anderson | South Carolina | — | — |
| 1245.25.10044 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | — | — |
| 1245.25.10002 Boehringer Ingelheim Investigational Site | Greer | South Carolina | — | — |
| 1245.25.10132 Boehringer Ingelheim Investigational Site | Hodges | South Carolina | — | — |
| 1245.25.10140 Boehringer Ingelheim Investigational Site | Mt. Pleasant | South Carolina | — | — |
| 1245.25.10065 Boehringer Ingelheim Investigational Site | Myrtle Beach | South Carolina | — | — |
| 1245.25.10127 Boehringer Ingelheim Investigational Site | Myrtle Beach | South Carolina | — | — |
| 1245.25.10170 Boehringer Ingelheim Investigational Site | North Myrtle Beach | South Carolina | — | — |
| 1245.25.10129 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina | — | — |
| 1245.25.10171 Boehringer Ingelheim Investigational Site | Union | South Carolina | — | — |
| 1245.25.10054 Boehringer Ingelheim Investigational Site | Bristol | Tennessee | — | — |
| 1245.25.10036 Boehringer Ingelheim Investigational Site | Chattanooga | Tennessee | — | — |
| 1245.25.10057 Boehringer Ingelheim Investigational Site | Chattanooga | Tennessee | — | — |
| 1245.25.10046 Boehringer Ingelheim Investigational Site | Kingsport | Tennessee | — | — |
| 1245.25.10143 Boehringer Ingelheim Investigational Site | Memphis | Tennessee | — | — |
| 1245.25.10075 Boehringer Ingelheim Investigational Site | Corpus Christi | Texas | — | — |
| 1245.25.10007 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1245.25.10026 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1245.25.10100 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1245.25.10165 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1245.25.10169 Boehringer Ingelheim Investigational Site | Fort Worth | Texas | — | — |
| 1245.25.10003 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1245.25.10125 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1245.25.10189 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1245.25.10119 Boehringer Ingelheim Investigational Site | Lubbock | Texas | — | — |
| 1245.25.10078 Boehringer Ingelheim Investigational Site | New Braunfels | Texas | — | — |
| 1245.25.10076 Boehringer Ingelheim Investigational Site | Odessa | Texas | — | — |
| 1245.25.10133 Boehringer Ingelheim Investigational Site | Pearland | Texas | — | — |
| 1245.25.10160 Boehringer Ingelheim Investigational Site | Plano | Texas | — | — |
| 1245.25.10177 Boehringer Ingelheim Investigational Site | Richardson | Texas | — | — |
| 1245.25.10049 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1245.25.10161 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1245.25.10185 Boehringer Ingelheim Investigational Site | Bountiful | Utah | — | — |
| 1245.25.10155 Boehringer Ingelheim Investigational Site | Draper | Utah | — | — |
| 1245.25.10079 Boehringer Ingelheim Investigational Site | Midvale | Utah | — | — |
| 1245.25.10080 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | — | — |
| 1245.25.10087 Boehringer Ingelheim Investigational Site | South Ogden | Utah | — | — |
| 1245.25.10218 Boehringer Ingelheim Investigational Site | Burke | Virginia | — | — |
| 1245.25.10004 Boehringer Ingelheim Investigational Site | Norfolk | Virginia | — | — |
| 1245.25.10111 Boehringer Ingelheim Investigational Site | South Chesterfield | Virginia | — | — |
| 1245.25.10115 Boehringer Ingelheim Investigational Site | Spokane | Washington | — | — |
| 1245.25.10216 Boehringer Ingelheim Investigational Site | Spokane | Washington | — | — |
| 1245.25.10017 Boehringer Ingelheim Investigational Site | Tacoma | Washington | — | — |
| 1245.25.10016 Boehringer Ingelheim Investigational Site | Walla Walla | Washington | — | — |
| 1245.25.10187 Boehringer Ingelheim Investigational Site | Charleston | West Virginia | — | — |
| 1245.25.10182 Boehringer Ingelheim Investigational Site | Morgantown | West Virginia | — | — |
| 1245.25.10098 Boehringer Ingelheim Investigational Site | Madison | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 445 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01131676, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 15, 2016 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01131676 live on ClinicalTrials.gov.