AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3NCT01131676

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

A Phase 3 study testing BI 10773 low dose and BI 10773 high dose in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 615 sites in 42 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
BI 10773 low dose and BI 10773 high dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
7,064 participants
Where
615 sitesin 42 countries
Study dates
Jul 2010to Apr 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of type 2 diabetes mellitus prior to informed consent
  • 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.
  • Glycosylated haemoglobin (HbA1c) of >= 7.0% and <=10% for patients on background therapy or HbA1c >= 7.0% and <= 9.0% for drug naive patients
  • Age >= 18 years
  • Body Mass index <= 45 at Visit 1
  • Signed and dated informed consent
  • High cardiovascular risk

Who cannot join

  • 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)
  • 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.
  • Planned cardiac surgery or angioplasty within 3 months
  • 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.
  • Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
  • Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
Show all 17Show fewer
  • Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
  • Contraindications to background therapy according to the local label
  • 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
  • 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
  • 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
  • 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
  • Participation in another trial with an investigational drug within 30 days prior to informed consent
  • Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
  • Acute coronary syndrome, stroke or TIA within 2 months prior to informed consent

Trial locations and contacts

615 sites in 42 countries.

615 sites in 42 countries

United States170 sites

  • 1245.25.10145 Boehringer Ingelheim Investigational Site

    Albuquerque, New Mexico

  • 1245.25.10180 Boehringer Ingelheim Investigational Site

    Albuquerque, New Mexico

  • 1245.25.10035 Boehringer Ingelheim Investigational Site

    Anaheim, California

  • 1245.25.10070 Boehringer Ingelheim Investigational Site

    Anderson, South Carolina

  • 1245.25.10023 Boehringer Ingelheim Investigational Site

    Atlanta, Georgia

  • 1245.25.10012 Boehringer Ingelheim Investigational Site

    Auburn, Maine

  • 1245.25.10041 Boehringer Ingelheim Investigational Site

    Baltimore, Maryland

  • 1245.25.10131 Boehringer Ingelheim Investigational Site

    Binghamton, New York

  • 1245.25.10043 Boehringer Ingelheim Investigational Site

    Birmingham, Alabama

  • 1245.25.10121 Boehringer Ingelheim Investigational Site

    Birmingham, Alabama

  • 1245.25.10092 Boehringer Ingelheim Investigational Site

    Boise, Idaho

  • 1245.25.10185 Boehringer Ingelheim Investigational Site

    Bountiful, Utah

  • 1245.25.10094 Boehringer Ingelheim Investigational Site

    Bradenton, Florida

  • 1245.25.10054 Boehringer Ingelheim Investigational Site

    Bristol, Tennessee

  • 1245.25.10190 Boehringer Ingelheim Investigational Site

    Brooksville, Florida

  • 1245.25.10218 Boehringer Ingelheim Investigational Site

    Burke, Virginia

  • 1245.25.10196 Boehringer Ingelheim Investigational Site

    Burlington, North Carolina

  • 1245.25.10207 Boehringer Ingelheim Investigational Site

    Calabash, North Carolina

  • 1245.25.10044 Boehringer Ingelheim Investigational Site

    Charleston, South Carolina

  • 1245.25.10187 Boehringer Ingelheim Investigational Site

    Charleston, West Virginia

  • 1245.25.10036 Boehringer Ingelheim Investigational Site

    Chattanooga, Tennessee

  • 1245.25.10057 Boehringer Ingelheim Investigational Site

    Chattanooga, Tennessee

  • 1245.25.10011 Boehringer Ingelheim Investigational Site

    Chesterfield, Missouri

  • 1245.25.10097 Boehringer Ingelheim Investigational Site

    Chicago, Illinois

  • 1245.25.10060 Boehringer Ingelheim Investigational Site

    Cincinnati, Ohio

  • 1245.25.10086 Boehringer Ingelheim Investigational Site

    Cincinnati, Ohio

  • 1245.25.10154 Boehringer Ingelheim Investigational Site

    Clairton, Pennsylvania

  • 1245.25.10173 Boehringer Ingelheim Investigational Site

    Clairton, Pennsylvania

  • 1245.25.10209 Boehringer Ingelheim Investigational Site

    Clearwater, Florida

  • 1245.25.10144 Boehringer Ingelheim Investigational Site

    Colorado Springs, Colorado

  • 1245.25.10174 Boehringer Ingelheim Investigational Site

    Columbus, Georgia

  • 1245.25.10212 Boehringer Ingelheim Investigational Site

    Cooper City, Florida

  • 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

  • 1245.25.10137 Boehringer Ingelheim Investigational Site

    Dayton, Ohio

  • 1245.25.10071 Boehringer Ingelheim Investigational Site

    Dearborn, Michigan

  • 1245.25.10138 Boehringer Ingelheim Investigational Site

    Delaware, Ohio

  • 1245.25.10200 Boehringer Ingelheim Investigational Site

    Delray Beach, Florida

  • 1245.25.10085 Boehringer Ingelheim Investigational Site

    Denver, Colorado

  • 1245.25.10153 Boehringer Ingelheim Investigational Site

    Denver, Colorado

  • 1245.25.10155 Boehringer Ingelheim Investigational Site

    Draper, Utah

  • 1245.25.10053 Boehringer Ingelheim Investigational Site

    Durham, North Carolina

  • 1245.25.10030 Boehringer Ingelheim Investigational Site

    Eagan, Minnesota

  • 1245.25.10103 Boehringer Ingelheim Investigational Site

    Encino, California

  • 1245.25.10082 Boehringer Ingelheim Investigational Site

    Eugene, Oregon

  • 1245.25.10116 Boehringer Ingelheim Investigational Site

    Evansville, Indiana

  • 1245.25.10052 Boehringer Ingelheim Investigational Site

    Feasterville-Trevose, Pennsylvania

  • 1245.25.10069 Boehringer Ingelheim Investigational Site

    Fleetwood, Pennsylvania

  • 1245.25.10014 Boehringer Ingelheim Investigational Site

    Flemington, New Jersey

  • 1245.25.10013 Boehringer Ingelheim Investigational Site

    Flint, Michigan

  • 1245.25.10033 Boehringer Ingelheim Investigational Site

    Fort Lauderdale, Florida

  • 1245.25.10169 Boehringer Ingelheim Investigational Site

    Fort Worth, Texas

  • 1245.25.10158 Boehringer Ingelheim Investigational Site

    Fresno, California

  • 1245.25.10056 Boehringer Ingelheim Investigational Site

    Gilbert, Arizona

  • 1245.25.10148 Boehringer Ingelheim Investigational Site

    Great Falls, Montana

  • 1245.25.10191 Boehringer Ingelheim Investigational Site

    Great Falls, Montana

  • 1245.25.10172 Boehringer Ingelheim Investigational Site

    Greensburg, Pennsylvania

  • 1245.25.10010 Boehringer Ingelheim Investigational Site

    Greenville, North Carolina

  • 1245.25.10002 Boehringer Ingelheim Investigational Site

    Greer, South Carolina

  • 1245.25.10202 Boehringer Ingelheim Investigational Site

    Hallandale, Florida

  • 1245.25.10126 Boehringer Ingelheim Investigational Site

    Harbor City, California

  • 1245.25.10048 Boehringer Ingelheim Investigational Site

    Harrisburg, Arkansas

  • 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

  • 1245.25.10132 Boehringer Ingelheim Investigational Site

    Hodges, South Carolina

  • 1245.25.10022 Boehringer Ingelheim Investigational Site

    Honolulu, Hawaii

  • 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

  • 1245.25.10058 Boehringer Ingelheim Investigational Site

    Huntington Park, California

  • 1245.25.10037 Boehringer Ingelheim Investigational Site

    Huntsville, Alabama

  • 1245.25.10134 Boehringer Ingelheim Investigational Site

    Hyattsville, Maryland

  • 1245.25.10050 Boehringer Ingelheim Investigational Site

    Indiana, Pennsylvania

  • 1245.25.10089 Boehringer Ingelheim Investigational Site

    Jacksonville, Florida

  • 1245.25.10163 Boehringer Ingelheim Investigational Site

    Kansas City, Missouri

  • 1245.25.10156 Boehringer Ingelheim Investigational Site

    Kettering, Ohio

  • 1245.25.10046 Boehringer Ingelheim Investigational Site

    Kingsport, Tennessee

  • 1245.25.10001 Boehringer Ingelheim Investigational Site

    Lancaster, California

  • 1245.25.10009 Boehringer Ingelheim Investigational Site

    Lansdale, Pennsylvania

  • 1245.25.10186 Boehringer Ingelheim Investigational Site

    Lexington, Kentucky

  • 1245.25.10015 Boehringer Ingelheim Investigational Site

    Little Rock, Alaska

  • 1245.25.10019 Boehringer Ingelheim Investigational Site

    Longwood, Florida

  • 1245.25.10102 Boehringer Ingelheim Investigational Site

    Los Angeles, California

  • 1245.25.10047 Boehringer Ingelheim Investigational Site

    Los Gatos, California

  • 1245.25.10109 Boehringer Ingelheim Investigational Site

    Louisville, Kentucky

  • 1245.25.10119 Boehringer Ingelheim Investigational Site

    Lubbock, Texas

  • 1245.25.10098 Boehringer Ingelheim Investigational Site

    Madison, Wisconsin

  • 1245.25.10006 Boehringer Ingelheim Investigational Site

    Madisonville, Kentucky

  • 1245.25.10168 Boehringer Ingelheim Investigational Site

    Maitland, Florida

  • 1245.25.10091 Boehringer Ingelheim Investigational Site

    Marion, Ohio

  • 1245.25.10143 Boehringer Ingelheim Investigational Site

    Memphis, Tennessee

  • 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

  • 1245.25.10079 Boehringer Ingelheim Investigational Site

    Midvale, Utah

  • 1245.25.10028 Boehringer Ingelheim Investigational Site

    Minneapolis, Minnesota

  • 1245.25.10124 Boehringer Ingelheim Investigational Site

    Mobile, Alabama

  • 1245.25.10182 Boehringer Ingelheim Investigational Site

    Morgantown, West Virginia

  • 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

  • 1245.25.10078 Boehringer Ingelheim Investigational Site

    New Braunfels, Texas

  • 1245.25.10020 Boehringer Ingelheim Investigational Site

    New Orleans, Louisiana

  • 1245.25.10004 Boehringer Ingelheim Investigational Site

    Norfolk, Virginia

  • 1245.25.10114 Boehringer Ingelheim Investigational Site

    Norman, Oklahoma

  • 1245.25.10170 Boehringer Ingelheim Investigational Site

    North Myrtle Beach, South Carolina

  • 1245.25.10066 Boehringer Ingelheim Investigational Site

    Norwalk, Connecticut

  • 1245.25.10076 Boehringer Ingelheim Investigational Site

    Odessa, Texas

  • 1245.25.10034 Boehringer Ingelheim Investigational Site

    Omaha, Nebraska

  • 1245.25.10123 Boehringer Ingelheim Investigational Site

    Orlando, Florida

  • 1245.25.10201 Boehringer Ingelheim Investigational Site

    Orlando, Florida

  • 1245.25.10005 Boehringer Ingelheim Investigational Site

    Paducah, Kentucky

  • 1245.25.10118 Boehringer Ingelheim Investigational Site

    Palm Springs, California

  • 1245.25.10133 Boehringer Ingelheim Investigational Site

    Pearland, Texas

  • 1245.25.10025 Boehringer Ingelheim Investigational Site

    Pembroke Pines, Florida

  • 1245.25.10042 Boehringer Ingelheim Investigational Site

    Pembroke Pines, Florida

  • 1245.25.10175 Boehringer Ingelheim Investigational Site

    Peoria, Arizona

  • 1245.25.10107 Boehringer Ingelheim Investigational Site

    Petoskey, Michigan

  • 1245.25.10214 Boehringer Ingelheim Investigational Site

    Philadelphia, Pennsylvania

  • 1245.25.10072 Boehringer Ingelheim Investigational Site

    Phoenix, Arizona

  • 1245.25.10176 Boehringer Ingelheim Investigational Site

    Picayune, Mississippi

  • 1245.25.10149 Boehringer Ingelheim Investigational Site

    Pittsburgh, Pennsylvania

  • 1245.25.10197 Boehringer Ingelheim Investigational Site

    Pittsburgh, Pennsylvania

  • 1245.25.10160 Boehringer Ingelheim Investigational Site

    Plano, Texas

  • 1245.25.10147 Boehringer Ingelheim Investigational Site

    Port Charlotte, Florida

  • 1245.25.10177 Boehringer Ingelheim Investigational Site

    Richardson, Texas

  • 1245.25.10141 Boehringer Ingelheim Investigational Site

    Riverdale, Georgia

  • 1245.25.10061 Boehringer Ingelheim Investigational Site

    Riverside, California

  • 1245.25.10029 Boehringer Ingelheim Investigational Site

    Rochester, New York

  • 1245.25.10067 Boehringer Ingelheim Investigational Site

    Roswell, Georgia

  • 1245.25.10080 Boehringer Ingelheim Investigational Site

    Salt Lake City, Utah

  • 1245.25.10049 Boehringer Ingelheim Investigational Site

    San Antonio, Texas

  • 1245.25.10161 Boehringer Ingelheim Investigational Site

    San Antonio, Texas

  • 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

  • 1245.25.10159 Boehringer Ingelheim Investigational Site

    Scottdale, Pennsylvania

  • 1245.25.10142 Boehringer Ingelheim Investigational Site

    Smithtown, New York

  • 1245.25.10111 Boehringer Ingelheim Investigational Site

    South Chesterfield, Virginia

  • 1245.25.10087 Boehringer Ingelheim Investigational Site

    South Ogden, Utah

  • 1245.25.10129 Boehringer Ingelheim Investigational Site

    Spartanburg, South Carolina

  • 1245.25.10115 Boehringer Ingelheim Investigational Site

    Spokane, Washington

  • 1245.25.10216 Boehringer Ingelheim Investigational Site

    Spokane, Washington

  • 1245.25.10064 Boehringer Ingelheim Investigational Site

    Springfield, Massachusetts

  • 1245.25.10198 Boehringer Ingelheim Investigational Site

    St. Petersburg, Florida

  • 1245.25.10203 Boehringer Ingelheim Investigational Site

    St. Petersburg, Florida

  • 1245.25.10096 Boehringer Ingelheim Investigational Site

    Staten Island, New York

  • 1245.25.10074 Boehringer Ingelheim Investigational Site

    Stockton, California

  • 1245.25.10017 Boehringer Ingelheim Investigational Site

    Tacoma, Washington

  • 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

  • 1245.25.10162 Boehringer Ingelheim Investigational Site

    Tipton, Pennsylvania

  • 1245.25.10210 Boehringer Ingelheim Investigational Site

    Towson, Maryland

  • 1245.25.10171 Boehringer Ingelheim Investigational Site

    Union, South Carolina

  • 1245.25.10146 Boehringer Ingelheim Investigational Site

    Uniontown, Pennsylvania

  • 1245.25.10083 Boehringer Ingelheim Investigational Site

    Valencia, California

  • 1245.25.10206 Boehringer Ingelheim Investigational Site

    Valparaiso, Indiana

  • 1245.25.10016 Boehringer Ingelheim Investigational Site

    Walla Walla, Washington

  • 1245.25.10068 Boehringer Ingelheim Investigational Site

    Washington D.C., District of Columbia

  • 1245.25.10038 Boehringer Ingelheim Investigational Site

    Waterbury, Connecticut

  • 1245.25.10051 Boehringer Ingelheim Investigational Site

    Watertown, Massachusetts

  • 1245.25.10021 Boehringer Ingelheim Investigational Site

    Wichita, Kansas

  • 1245.25.10077 Boehringer Ingelheim Investigational Site

    Yardley, Pennsylvania

  • 1245.25.10192 Boehringer Ingelheim Investigational Site

    Zanesville, Ohio

Other trials in United States

Brazil25 sites

  • 1245.25.55014 Boehringer Ingelheim Investigational Site

    Belém

  • 1245.25.55019 Boehringer Ingelheim Investigational Site

    Belo Horizonte

  • 1245.25.55007 Boehringer Ingelheim Investigational Site

    Boqueirão

  • 1245.25.55015 Boehringer Ingelheim Investigational Site

    Brasília

  • 1245.25.55027 Boehringer Ingelheim Investigational Site

    Campinas

  • 1245.25.55028 Boehringer Ingelheim Investigational Site

    Campinas

  • 1245.25.55025 Boehringer Ingelheim Investigational Site

    Curitiba

  • 1245.25.55026 Boehringer Ingelheim Investigational Site

    Fortaleza

  • 1245.25.55009 Boehringer Ingelheim Investigational Site

    Goiânia

  • 1245.25.55002 Boehringer Ingelheim Investigational Site

    Higienópolis

  • 1245.25.55017 Boehringer Ingelheim Investigational Site

    Marília

  • 1245.25.55022 Boehringer Ingelheim Investigational Site

    Maringá

  • 1245.25.55008 Boehringer Ingelheim Investigational Site

    Porto Alegre

  • 1245.25.55016 Boehringer Ingelheim Investigational Site

    Porto Alegre

  • 1245.25.55020 Boehringer Ingelheim Investigational Site

    Porto Alegre

  • 1245.25.55012 Boehringer Ingelheim Investigational Site

    Ribeirão Preto

  • 1245.25.55013 Boehringer Ingelheim Investigational Site

    São José do Rio Preto

  • 1245.25.55004 Boehringer Ingelheim Investigational Site

    São Paulo

  • 1245.25.55010 Boehringer Ingelheim Investigational Site

    São Paulo

  • 1245.25.55018 Boehringer Ingelheim Investigational Site

    São Paulo

  • 1245.25.55023 Boehringer Ingelheim Investigational Site

    São Paulo

  • 1245.25.55006 Boehringer Ingelheim Investigational Site

    Vila Albuquerque

  • 1245.25.55003 Boehringer Ingelheim Investigational Site

    Vila Clementino

  • 1245.25.55005 Boehringer Ingelheim Investigational Site

    Vila Leopoldina

  • 1245.25.55001 Boehringer Ingelheim Investigational Site

    Villa Clementino

Other trials in Brazil

Russia25 sites

  • 1245.25.70019 Boehringer Ingelheim Investigational Site

    Barnaul

  • 1245.25.70015 Boehringer Ingelheim Investigational Site

    Kemerovo

  • 1245.25.70020 Boehringer Ingelheim Investigational Site

    Kemerovo

  • 1245.25.70003 Boehringer Ingelheim Investigational Site

    Moscow

  • 1245.25.70009 Boehringer Ingelheim Investigational Site

    Moscow

  • 1245.25.70011 Boehringer Ingelheim Investigational Site

    Moscow

  • 1245.25.70016 Boehringer Ingelheim Investigational Site

    Moscow

  • 1245.25.70021 Boehringer Ingelheim Investigational Site

    Moscow

  • 1245.25.70022 Boehringer Ingelheim Investigational Site

    Moscow

  • 1245.25.70014 Boehringer Ingelheim Investigational Site

    Novosibirsk

  • 1245.25.70018 Boehringer Ingelheim Investigational Site

    Novosibirsk

  • 1245.25.70024 Boehringer Ingelheim Investigational Site

    Novosibirsk

  • 1245.25.70028 Boehringer Ingelheim Investigational Site

    Novosibirsk

  • 1245.25.70001 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 1245.25.70004 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 1245.25.70005 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 1245.25.70006 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 1245.25.70013 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 1245.25.70017 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 1245.25.70023 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 1245.25.70025 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 1245.25.70026 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 1245.25.70027 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 1245.25.70002 Boehringer Ingelheim Investigational Site

    Vsevolozhsk

  • 1245.25.70029 Boehringer Ingelheim Investigational Site

    Yaroslavl

Other trials in Russia

Spain23 sites

  • 1245.25.34025 Boehringer Ingelheim Investigational Site

    Alcorcon (Madrid)

  • 1245.25.34048 Boehringer Ingelheim Investigational Site

    Alicante

  • 1245.25.34050 Boehringer Ingelheim Investigational Site

    Alzira

  • 1245.25.34039 Boehringer Ingelheim Investigational Site

    Ávila

  • 1245.25.34040 Boehringer Ingelheim Investigational Site

    Badía Del Vallès - Barcelona

  • 1245.25.34029 Boehringer Ingelheim Investigational Site

    Barcelona

  • 1245.25.34030 Boehringer Ingelheim Investigational Site

    Barcelona

  • 1245.25.34049 Boehringer Ingelheim Investigational Site

    Barcelona

  • 1245.25.34031 Boehringer Ingelheim Investigational Site

    Granada

  • 1245.25.34024 Boehringer Ingelheim Investigational Site

    Leganes (Madrid)

  • 1245.25.34013 Boehringer Ingelheim Investigational Site

    Madrid

  • 1245.25.34023 Boehringer Ingelheim Investigational Site

    Madrid

  • 1245.25.34026 Boehringer Ingelheim Investigational Site

    Madrid

  • 1245.25.34028 Boehringer Ingelheim Investigational Site

    Madrid

  • 1245.25.34033 Boehringer Ingelheim Investigational Site

    Madrid

  • 1245.25.34036 Boehringer Ingelheim Investigational Site

    Madrid

  • 1245.25.34038 Boehringer Ingelheim Investigational Site

    Madrid

  • 1245.25.34022 Boehringer Ingelheim Investigational Site

    Mahadahonda (Madrid)

  • 1245.25.34047 Boehringer Ingelheim Investigational Site

    Palma de Mallorca

  • 1245.25.34034 Boehringer Ingelheim Investigational Site

    Sabadell (Barcelona)

  • 1245.25.34027 Boehringer Ingelheim Investigational Site

    Salamanca

  • 1245.25.34037 Boehringer Ingelheim Investigational Site

    Santa Cruz de Tenerife

  • 1245.25.34046 Boehringer Ingelheim Investigational Site

    Segovia

Other trials in Spain

South Africa21 sites

  • 1245.25.76007 Boehringer Ingelheim Investigational Site

    Alberton

  • 1245.25.76002 Boehringer Ingelheim Investigational Site

    Bellville

  • 1245.25.76009 Boehringer Ingelheim Investigational Site

    Bloemfontein

  • 1245.25.76014 Boehringer Ingelheim Investigational Site

    Cape Town

  • 1245.25.76020 Boehringer Ingelheim Investigational Site

    Cape Town

  • 1245.25.76022 Boehringer Ingelheim Investigational Site

    Chatsworth Unit 10

  • 1245.25.76013 Boehringer Ingelheim Investigational Site

    Durban

  • 1245.25.76016 Boehringer Ingelheim Investigational Site

    Durban

  • 1245.25.76019 Boehringer Ingelheim Investigational Site

    Durban

  • 1245.25.76003 Boehringer Ingelheim Investigational Site

    Goodwood

  • 1245.25.76001 Boehringer Ingelheim Investigational Site

    Houghton Estate

  • 1245.25.76021 Boehringer Ingelheim Investigational Site

    Kempton Park

  • 1245.25.76017 Boehringer Ingelheim Investigational Site

    Krugersdorp

  • 1245.25.76004 Boehringer Ingelheim Investigational Site

    Newtown

  • 1245.25.76006 Boehringer Ingelheim Investigational Site

    Paarl

  • 1245.25.76005 Boehringer Ingelheim Investigational Site

    Parow

  • 1245.25.76018 Boehringer Ingelheim Investigational Site

    Port Elizabeth

  • 1245.25.76015 Boehringer Ingelheim Investigational Site

    Somerset West

  • 1245.25.76012 Boehringer Ingelheim Investigational Site

    Sydenham

  • 1245.25.76008 Boehringer Ingelheim Investigational Site

    Tongaat

  • 1245.25.76023 Boehringer Ingelheim Investigational Site

    Worcester

Other trials in South Africa

Netherlands20 sites

  • 1245.25.31015 Boehringer Ingelheim Investigational Site

    Amersfoort

  • 1245.25.31013 Boehringer Ingelheim Investigational Site

    Apeldoorn

  • 1245.25.31036 Boehringer Ingelheim Investigational Site

    Baarle-Nassau

  • 1245.25.31032 Boehringer Ingelheim Investigational Site

    Delft

  • 1245.25.31026 Boehringer Ingelheim Investigational Site

    Den Helder

  • 1245.25.31012 Boehringer Ingelheim Investigational Site

    Geleen

  • 1245.25.31017 Boehringer Ingelheim Investigational Site

    Hardenberg

  • 1245.25.31035 Boehringer Ingelheim Investigational Site

    Heerlen

  • 1245.25.31011 Boehringer Ingelheim Investigational Site

    Hoogeveen

  • 1245.25.31029 Boehringer Ingelheim Investigational Site

    Hoogezand

  • 1245.25.31023 Boehringer Ingelheim Investigational Site

    Hoogwoud

  • 1245.25.31009 Boehringer Ingelheim Investigational Site

    Maastricht

  • 1245.25.31031 Boehringer Ingelheim Investigational Site

    Meppel

  • 1245.25.31024 Boehringer Ingelheim Investigational Site

    Nijverdal

  • 1245.25.31014 Boehringer Ingelheim Investigational Site

    Rotterdam

  • 1245.25.31033 Boehringer Ingelheim Investigational Site

    Rotterdam

  • 1245.25.31030 Boehringer Ingelheim Investigational Site

    Schiedam

  • 1245.25.31002 Boehringer Ingelheim Investigational Site

    Utrecht

  • 1245.25.31028 Boehringer Ingelheim Investigational Site

    Wildervank

  • 1245.25.31034 Boehringer Ingelheim Investigational Site

    Zutphen

Other trials in Netherlands

India18 sites

  • 1245.25.91307 Boehringer Ingelheim Investigational Site

    Ahmedabad

  • 1245.25.91302 Boehringer Ingelheim Investigational Site

    Bangalore

  • 1245.25.91317 Boehringer Ingelheim Investigational Site

    Bangalore

  • 1245.25.91319 Boehringer Ingelheim Investigational Site

    Bangalore

  • 1245.25.91320 Boehringer Ingelheim Investigational Site

    Bangalore

  • 1245.25.91303 Boehringer Ingelheim Investigational Site

    Chennai

  • 1245.25.91311 Boehringer Ingelheim Investigational Site

    Hyderabad

  • 1245.25.91318 Boehringer Ingelheim Investigational Site

    Indore

  • 1245.25.91305 Boehringer Ingelheim Investigational Site

    Jaipur

  • 1245.25.91309 Boehringer Ingelheim Investigational Site

    Jalandhar

  • 1245.25.91315 Boehringer Ingelheim Investigational Site

    Kochi

  • 1245.25.91313 Boehringer Ingelheim Investigational Site

    Nagpur

  • 1245.25.91324 Boehringer Ingelheim Investigational Site

    Nagpur

  • 1245.25.91301 Boehringer Ingelheim Investigational Site

    Nashik, Maharashtra

  • 1245.25.91308 Boehringer Ingelheim Investigational Site

    Pune

  • 1245.25.91316 Boehringer Ingelheim Investigational Site

    Secunderabad

  • 1245.25.91321 Boehringer Ingelheim Investigational Site

    Varanasi

  • 1245.25.91314 Boehringer Ingelheim Investigational Site

    Vijaywada

Other trials in India

South Korea17 sites

  • 1245.25.82030 Boehringer Ingelheim Investigational Site

    Busan

  • 1245.25.82018 Boehringer Ingelheim Investigational Site

    Daegu

  • 1245.25.82021 Boehringer Ingelheim Investigational Site

    Daejeon

  • 1245.25.82031 Boehringer Ingelheim Investigational Site

    Daejoen

  • 1245.25.82027 Boehringer Ingelheim Investigational Site

    Goyang

  • 1245.25.82022 Boehringer Ingelheim Investigational Site

    Gwangju

  • 1245.25.82029 Boehringer Ingelheim Investigational Site

    Incheon

  • 1245.25.82017 Boehringer Ingelheim Investigational Site

    Pusan

  • 1245.25.82015 Boehringer Ingelheim Investigational Site

    Seoul

  • 1245.25.82016 Boehringer Ingelheim Investigational Site

    Seoul

  • 1245.25.82019 Boehringer Ingelheim Investigational Site

    Seoul

  • 1245.25.82020 Boehringer Ingelheim Investigational Site

    Seoul

  • 1245.25.82023 Boehringer Ingelheim Investigational Site

    Seoul

  • 1245.25.82024 Boehringer Ingelheim Investigational Site

    Seoul

  • 1245.25.82025 Boehringer Ingelheim Investigational Site

    Seoul

  • 1245.25.82026 Boehringer Ingelheim Investigational Site

    Suwon

  • 1245.25.82028 Boehringer Ingelheim Investigational Site

    Wŏnju

Other trials in South Korea

Belgium16 sites

  • 1245.25.32010 Boehringer Ingelheim Investigational Site

    Bonheiden

  • 1245.25.32008 Boehringer Ingelheim Investigational Site

    Brussels

  • 1245.25.32011 Boehringer Ingelheim Investigational Site

    Brussels

  • 1245.25.32030 Boehringer Ingelheim Investigational Site

    Brussels

  • 1245.25.32003 Boehringer Ingelheim Investigational Site

    De Pinte

  • 1245.25.32002 Boehringer Ingelheim Investigational Site

    Edegem

  • 1245.25.32004 Boehringer Ingelheim Investigational Site

    Genk

  • 1245.25.32029 Boehringer Ingelheim Investigational Site

    Halen

  • 1245.25.32009 Boehringer Ingelheim Investigational Site

    Hasselt

  • 1245.25.32007 Boehringer Ingelheim Investigational Site

    Huy

  • 1245.25.32013 Boehringer Ingelheim Investigational Site

    La Louvière

  • 1245.25.32012 Boehringer Ingelheim Investigational Site

    Leuven

  • 1245.25.32001 Boehringer Ingelheim Investigational Site

    Liège

  • 1245.25.32028 Boehringer Ingelheim Investigational Site

    Liège

  • 1245.25.32005 Boehringer Ingelheim Investigational Site

    Massemen-Wetteren

  • 1245.25.32014 Boehringer Ingelheim Investigational Site

    Oostham

Other trials in Belgium

France16 sites

  • 1245.25.33022 Boehringer Ingelheim Investigational Site

    Amiens

  • 1245.25.33033 Boehringer Ingelheim Investigational Site

    Angers

  • 1245.25.33034 Boehringer Ingelheim Investigational Site

    Angers

  • 1245.25.33030 Boehringer Ingelheim Investigational Site

    Bourg Des Cptes

  • 1245.25.33023 Boehringer Ingelheim Investigational Site

    Corbeil-Essonnes

  • 1245.25.33024 Boehringer Ingelheim Investigational Site

    Derval

  • 1245.25.33029 Boehringer Ingelheim Investigational Site

    Equeurdreville Haineville

  • 1245.25.33027 Boehringer Ingelheim Investigational Site

    Fleury-sur-Orne

  • 1245.25.33021 Boehringer Ingelheim Investigational Site

    Grenoble

  • 1245.25.33003 Boehringer Ingelheim Investigational Site

    La Rochelle

  • 1245.25.33032 Boehringer Ingelheim Investigational Site

    Le Creusot

  • 1245.25.33004 Boehringer Ingelheim Investigational Site

    Narbonne

  • 1245.25.33047 Boehringer Ingelheim Investigational Site

    Pessac

  • 1245.25.33046 Boehringer Ingelheim Investigational Site

    Poitiers

  • 1245.25.33025 Boehringer Ingelheim Investigational Site

    Saint Priez En Jarez

  • 1245.25.33035 Boehringer Ingelheim Investigational Site

    Tours

Other trials in France

Italy15 sites

  • 1245.25.39007 Boehringer Ingelheim Investigational Site

    Bologna

  • 1245.25.39002 Boehringer Ingelheim Investigational Site

    Campobasso

  • 1245.25.39008 Boehringer Ingelheim Investigational Site

    Catanzaro

  • 1245.25.39010 Boehringer Ingelheim Investigational Site

    Chieti

  • 1245.25.39024 Boehringer Ingelheim Investigational Site

    Ferrara

  • 1245.25.39009 Boehringer Ingelheim Investigational Site

    Florence

  • 1245.25.39005 Boehringer Ingelheim Investigational Site

    Foggia

  • 1245.25.39004 Boehringer Ingelheim Investigational Site

    Naples

  • 1245.25.39006 Boehringer Ingelheim Investigational Site

    Padova

  • 1245.25.39001 Boehringer Ingelheim Investigational Site

    Pisa

  • 1245.25.39003 Boehringer Ingelheim Investigational Site

    Roma

  • 1245.25.39011 Boehringer Ingelheim Investigational Site

    Roma

  • 1245.25.39012 Boehringer Ingelheim Investigational Site

    Roma

  • 1245.25.39014 Boehringer Ingelheim Investigational Site

    Roma

  • 1245.25.39013 Boehringer Ingelheim Investigational Site

    Venezia

Other trials in Italy

Japan14 sites

  • 1245.25.81008 Boehringer Ingelheim Investigational Site

    Chuo-ku, Tokyo

  • 1245.25.81010 Boehringer Ingelheim Investigational Site

    Gifushi, Gifu

  • 1245.25.81002 Boehringer Ingelheim Investigational Site

    Hanyushi, Saitama

  • 1245.25.81013 Boehringer Ingelheim Investigational Site

    Kamigyo-ku, Kyotoshi, Kyoto

  • 1245.25.81003 Boehringer Ingelheim Investigational Site

    Kishiwadashi. Osaka

  • 1245.25.81012 Boehringer Ingelheim Investigational Site

    Kita-ku, Nagoyashi, Aichi

  • 1245.25.81014 Boehringer Ingelheim Investigational Site

    Kumamoto-shi, Kumamoto

  • 1245.25.81001 Boehringer Ingelheim Investigational Site

    Matsudoshi, Chiba

  • 1245.25.81006 Boehringer Ingelheim Investigational Site

    Mitoshi, Ibaraki

  • 1245.25.81005 Boehringer Ingelheim Investigational Site

    Nishi-ku, Sapporoshi, Hokkaido

  • 1245.25.81007 Boehringer Ingelheim Investigational Site

    Nodashi, Chiba

  • 1245.25.81004 Boehringer Ingelheim Investigational Site

    Shimajiri-gun,Okinawa

  • 1245.25.81009 Boehringer Ingelheim Investigational Site

    Toyamashi, Toyama

  • 1245.25.81015 Boehringer Ingelheim Investigational Site

    Toyoakeshi, Aichi

Other trials in Japan

Portugal14 sites

  • 1245.25.35006 Boehringer Ingelheim Investigational Site

    Amadora

  • 1245.25.35004 Boehringer Ingelheim Investigational Site

    Coimbra

  • 1245.25.35018 Boehringer Ingelheim Investigational Site

    Faro

  • 1245.25.35021 Boehringer Ingelheim Investigational Site

    Funchal

  • 1245.25.35008 Boehringer Ingelheim Investigational Site

    Leiria

  • 1245.25.35001 Boehringer Ingelheim Investigational Site

    Lisbon

  • 1245.25.35002 Boehringer Ingelheim Investigational Site

    Lisbon

  • 1245.25.35015 Boehringer Ingelheim Investigational Site

    Lisbon

  • 1245.25.35017 Boehringer Ingelheim Investigational Site

    Lisbon

  • 1245.25.35011 Boehringer Ingelheim Investigational Site

    Porto

  • 1245.25.35005 Boehringer Ingelheim Investigational Site

    Santiago do Cacém

  • 1245.25.35020 Boehringer Ingelheim Investigational Site

    Torres Novas

  • 1245.25.35014 Boehringer Ingelheim Investigational Site

    Viana do Castelo

  • 1245.25.35019 Boehringer Ingelheim Investigational Site

    Vila Nova de Gaia

Other trials in Portugal

Canada13 sites

  • 1245.25.20045 Boehringer Ingelheim Investigational Site

    Brampton, Ontario

  • 1245.25.20042 Boehringer Ingelheim Investigational Site

    Burlington, Ontario

  • 1245.25.20050 Boehringer Ingelheim Investigational Site

    Gatineau, Quebec

  • 1245.25.20026 Boehringer Ingelheim Investigational Site

    Halifax, Nova Scotia

  • 1245.25.20043 Boehringer Ingelheim Investigational Site

    Longueuil, Quebec

  • 1245.25.20046 Boehringer Ingelheim Investigational Site

    Longueuil, Quebec

  • 1245.25.20009 Boehringer Ingelheim Investigational Site

    Newmarket, Ontario

  • 1245.25.20044 Boehringer Ingelheim Investigational Site

    Niagara Falls, Ontario

  • 1245.25.20013 Boehringer Ingelheim Investigational Site

    Ottawa, Ontario

  • 1245.25.20041 Boehringer Ingelheim Investigational Site

    Saskatoon, Saskatchewan

  • 1245.25.20049 Boehringer Ingelheim Investigational Site

    Toronto, Ontario

  • 1245.25.20047 Boehringer Ingelheim Investigational Site

    Vancouver, British Columbia

  • 1245.25.20048 Boehringer Ingelheim Investigational Site

    Winnipeg, Manitoba

Other trials in Canada

United Kingdom12 sites

  • 1245.25.44045 Boehringer Ingelheim Investigational Site

    Airdrie

  • 1245.25.44020 Boehringer Ingelheim Investigational Site

    Ashford

  • 1245.25.44013 Boehringer Ingelheim Investigational Site

    Blackpool

  • 1245.25.44014 Boehringer Ingelheim Investigational Site

    Bolton

  • 1245.25.44021 Boehringer Ingelheim Investigational Site

    Bradford on Avon

  • 1245.25.44002 Boehringer Ingelheim Investigational Site

    Dumfries

  • 1245.25.44009 Boehringer Ingelheim Investigational Site

    Dundee

  • 1245.25.44005 Boehringer Ingelheim Investigational Site

    Edinburgh

  • 1245.25.44004 Boehringer Ingelheim Investigational Site

    Fowey

  • 1245.25.44001 Boehringer Ingelheim Investigational Site

    Frome

  • 1245.25.44003 Boehringer Ingelheim Investigational Site

    Inverness

  • 1245.25.44044 Boehringer Ingelheim Investigational Site

    Wishaw

Other trials in United Kingdom

Argentina11 sites

  • 1245.25.54012 Boehringer Ingelheim Investigational Site

    Buenos Aires

  • 1245.25.54001 Boehringer Ingelheim Investigational Site

    Capital Federal

  • 1245.25.54006 Boehringer Ingelheim Investigational Site

    Capital Federal

  • 1245.25.54013 Boehringer Ingelheim Investigational Site

    Capital Federal

  • 1245.25.54002 Boehringer Ingelheim Investigational Site

    Córdoba

  • 1245.25.54003 Boehringer Ingelheim Investigational Site

    Córdoba

  • 1245.25.54010 Boehringer Ingelheim Investigational Site

    Córdoba

  • 1245.25.54011 Boehringer Ingelheim Investigational Site

    Córdoba

  • 1245.25.54005 Boehringer Ingelheim Investigational Site

    Parque Velez Sarfield

  • 1245.25.54008 Boehringer Ingelheim Investigational Site

    Rosario

  • 1245.25.54009 Boehringer Ingelheim Investigational Site

    Rosario

Other trials in Argentina

Peru11 sites

  • 1245.25.51001 Boehringer Ingelheim Investigational Site

    Arequipa

  • 1245.25.51008 Boehringer Ingelheim Investigational Site

    Arequipa

  • 1245.25.51002 Boehringer Ingelheim Investigational Site

    Bellavista

  • 1245.25.51004 Boehringer Ingelheim Investigational Site

    El Agustino

  • 1245.25.51006 Boehringer Ingelheim Investigational Site

    Ica

  • 1245.25.51003 Boehringer Ingelheim Investigational Site

    Jesus Maria

  • 1245.25.51007 Boehringer Ingelheim Investigational Site

    Lima

  • 1245.25.51009 Boehringer Ingelheim Investigational Site

    Lima

  • 1245.25.51010 Boehringer Ingelheim Investigational Site

    Lima

  • 1245.25.51011 Boehringer Ingelheim Investigational Site

    Lima

  • 1245.25.51005 Boehringer Ingelheim Investigational Site

    Miraflores

Other trials in Peru

Poland11 sites

  • 1245.25.48013 Boehringer Ingelheim Investigational Site

    Gdansk

  • 1245.25.48004 Boehringer Ingelheim Investigational Site

    Lodz

  • 1245.25.48009 Boehringer Ingelheim Investigational Site

    Lodz

  • 1245.25.48010 Boehringer Ingelheim Investigational Site

    Lodz

  • 1245.25.48001 Boehringer Ingelheim Investigational Site

    Lublin

  • 1245.25.48014 Boehringer Ingelheim Investigational Site

    Oświęcim

  • 1245.25.48002 Boehringer Ingelheim Investigational Site

    Poznan

  • 1245.25.48008 Boehringer Ingelheim Investigational Site

    Puławy

  • 1245.25.48007 Boehringer Ingelheim Investigational Site

    Ruda Śląska

  • 1245.25.48005 Boehringer Ingelheim Investigational Site

    Torun

  • 1245.25.48011 Boehringer Ingelheim Investigational Site

    Torun

Other trials in Poland

Austria10 sites

  • 1245.25.43008 Boehringer Ingelheim Investigational Site

    Feldkirch

  • 1245.25.43006 Boehringer Ingelheim Investigational Site

    Graz

  • 1245.25.43016 Boehringer Ingelheim Investigational Site

    Innsbruck

  • 1245.25.43005 Boehringer Ingelheim Investigational Site

    Salzburg

  • 1245.25.43015 Boehringer Ingelheim Investigational Site

    St. Stefan

  • 1245.25.43001 Boehringer Ingelheim Investigational Site

    Vienna

  • 1245.25.43007 Boehringer Ingelheim Investigational Site

    Vienna

  • 1245.25.43009 Boehringer Ingelheim Investigational Site

    Vienna

  • 1245.25.43010 Boehringer Ingelheim Investigational Site

    Vienna

  • 1245.25.43013 Boehringer Ingelheim Investigational Site

    Vienna

Other trials in Austria

Malaysia10 sites

  • 1245.25.60019 Boehringer Ingelheim Investigational Site

    Johor Bahru

  • 1245.25.60020 Boehringer Ingelheim Investigational Site

    Kedah

  • 1245.25.60013 Boehringer Ingelheim Investigational Site

    Kelantan

  • 1245.25.60015 Boehringer Ingelheim Investigational Site

    Kota Kinabalu

  • 1245.25.60012 Boehringer Ingelheim Investigational Site

    Kuala Lumpur

  • 1245.25.60017 Boehringer Ingelheim Investigational Site

    Kuala Lumpur

  • 1245.25.60004 Boehringer Ingelheim Investigational Site

    Kuala Pahang

  • 1245.25.60016 Boehringer Ingelheim Investigational Site

    Kuala Selangor

  • 1245.25.60021 Boehringer Ingelheim Investigational Site

    Kuala Selangor

  • 1245.25.60018 Boehringer Ingelheim Investigational Site

    Selangor Darul Ehsan

Other trials in Malaysia

Philippines10 sites

  • 1245.25.63016 Boehringer Ingelheim Investigational Site

    Cavite City

  • 1245.25.63002 Boehringer Ingelheim Investigational Site

    Cebu

  • 1245.25.63003 Boehringer Ingelheim Investigational Site

    Davao City

  • 1245.25.63020 Boehringer Ingelheim Investigational Site

    Jaro Iloilo City

  • 1245.25.63001 Boehringer Ingelheim Investigational Site

    Manila

  • 1245.25.63004 Boehringer Ingelheim Investigational Site

    Manila

  • 1245.25.63018 Boehringer Ingelheim Investigational Site

    Manila

  • 1245.25.63009 Boehringer Ingelheim Investigational Site

    Marikina City

  • 1245.25.63021 Boehringer Ingelheim Investigational Site

    Marikina City

  • 1245.25.63019 Boehringer Ingelheim Investigational Site

    Tarlac City

Other trials in Philippines

Taiwan10 sites

  • 1245.25.88022 Boehringer Ingelheim Investigational Site

    Hualien City

  • 1245.25.88010 Boehringer Ingelheim Investigational Site

    Kaohsiung City

  • 1245.25.88019 Boehringer Ingelheim Investigational Site

    Kaohsiung City

  • 1245.25.88009 Boehringer Ingelheim Investigational Site

    Taichung

  • 1245.25.88020 Boehringer Ingelheim Investigational Site

    Taichung

  • 1245.25.88018 Boehringer Ingelheim Investigational Site

    Tainan

  • 1245.25.88015 Boehringer Ingelheim Investigational Site

    Taipei

  • 1245.25.88016 Boehringer Ingelheim Investigational Site

    Taipei

  • 1245.25.88023 Boehringer Ingelheim Investigational Site

    Tamsui, Taipei County

  • 1245.25.88017 Boehringer Ingelheim Investigational Site

    Taoyuan

Other trials in Taiwan

Romania9 sites

  • 1245.25.40008 Boehringer Ingelheim Investigational Site

    Alba Iulia

  • 1245.25.40011 Boehringer Ingelheim Investigational Site

    Baia Mare Maramures

  • 1245.25.40003 Boehringer Ingelheim Investigational Site

    Bucharest

  • 1245.25.40007 Boehringer Ingelheim Investigational Site

    Bucharest

  • 1245.25.40005 Boehringer Ingelheim Investigational Site

    Constanța

  • 1245.25.40002 Boehringer Ingelheim Investigational Site

    Craiova

  • 1245.25.40006 Boehringer Ingelheim Investigational Site

    Craiova

  • 1245.25.40009 Boehringer Ingelheim Investigational Site

    Oradea

  • 1245.25.40010 Boehringer Ingelheim Investigational Site

    Târgu Mureş

Other trials in Romania

Georgia8 sites

  • 1245.25.99001 Boehringer Ingelheim Investigational Site

    Batumi

  • 1245.25.99003 Boehringer Ingelheim Investigational Site

    Kutaisi

  • 1245.25.99002 Boehringer Ingelheim Investigational Site

    Tbilisi

  • 1245.25.99004 Boehringer Ingelheim Investigational Site

    Tbilisi

  • 1245.25.99005 Boehringer Ingelheim Investigational Site

    Tbilisi

  • 1245.25.99006 Boehringer Ingelheim Investigational Site

    Tbilisi

  • 1245.25.99007 Boehringer Ingelheim Investigational Site

    Tbilisi

  • 1245.25.99008 Boehringer Ingelheim Investigational Site

    Tbilisi

Other trials in Georgia

Greece8 sites

  • 1245.25.30002 Boehringer Ingelheim Investigational Site

    Athens

  • 1245.25.30003 Boehringer Ingelheim Investigational Site

    Athens

  • 1245.25.30004 Boehringer Ingelheim Investigational Site

    Athens

  • 1245.25.30007 Boehringer Ingelheim Investigational Site

    Athens

  • 1245.25.30005 Boehringer Ingelheim Investigational Site

    Larissa

  • 1245.25.30001 Boehringer Ingelheim Investigational Site

    Nikaia

  • 1245.25.30006 Boehringer Ingelheim Investigational Site

    Thessaloniki

  • 1245.25.30008 Boehringer Ingelheim Investigational Site

    Thessaloniki

Other trials in Greece

Hungary8 sites

  • 1245.25.36002 Boehringer Ingelheim Investigational Site

    Budapest

  • 1245.25.36004 Boehringer Ingelheim Investigational Site

    Budapest

  • 1245.25.36008 Boehringer Ingelheim Investigational Site

    Budapest

  • 1245.25.36006 Boehringer Ingelheim Investigational Site

    Dunaújváros

  • 1245.25.36001 Boehringer Ingelheim Investigational Site

    Gyula

  • 1245.25.36010 Boehringer Ingelheim Investigational Site

    Kisvárda

  • 1245.25.36003 Boehringer Ingelheim Investigational Site

    Szekszárd

  • 1245.25.36011 Boehringer Ingelheim Investigational Site

    Szikszó

Other trials in Hungary

Indonesia8 sites

  • 1245.25.62006 Boehringer Ingelheim Investigational Site

    Denpasar

  • 1245.25.62009 Boehringer Ingelheim Investigational Site

    Depok

  • 1245.25.62002 Boehringer Ingelheim Investigational Site

    Jakarta

  • 1245.25.62008 Boehringer Ingelheim Investigational Site

    Jakarta

  • 1245.25.62010 Boehringer Ingelheim Investigational Site

    Jakarta

  • 1245.25.62004 Boehringer Ingelheim Investigational Site

    Malang

  • 1245.25.62003 Boehringer Ingelheim Investigational Site

    Surabaya

  • 1245.25.62001 Boehringer Ingelheim Investigational Site

    Yogyakarta

Other trials in Indonesia

Norway8 sites

  • 1245.25.47002 Boehringer Ingelheim Investigational Site

    Fornebu

  • 1245.25.47004 Boehringer Ingelheim Investigational Site

    Gjøvik

  • 1245.25.47009 Boehringer Ingelheim Investigational Site

    Kløfta

  • 1245.25.47008 Boehringer Ingelheim Investigational Site

    Kongsvinger

  • 1245.25.47001 Boehringer Ingelheim Investigational Site

    Oslo

  • 1245.25.47006 Boehringer Ingelheim Investigational Site

    Oslo

  • 1245.25.47007 Boehringer Ingelheim Investigational Site

    Trondheim

  • 1245.25.47005 Boehringer Ingelheim Investigational Site

    Tynset

Other trials in Norway

Colombia7 sites

  • 1245.25.57010 Boehringer Ingelheim Investigational Site

    Armenia

  • 1245.25.57004 Boehringer Ingelheim Investigational Site

    Barranquilla

  • 1245.25.57001 Boehringer Ingelheim Investigational Site

    Bogotá

  • 1245.25.57003 Boehringer Ingelheim Investigational Site

    Bogotá

  • 1245.25.57011 Boehringer Ingelheim Investigational Site

    Bogotá

  • 1245.25.57006 Boehringer Ingelheim Investigational Site

    Floridablanca

  • 1245.25.57009 Boehringer Ingelheim Investigational Site

    Medellín

Other trials in Colombia

Israel7 sites

  • 1245.25.97003 Boehringer Ingelheim Investigational Site

    Afula

  • 1245.25.97006 Boehringer Ingelheim Investigational Site

    Hadera

  • 1245.25.97008 Boehringer Ingelheim Investigational Site

    Haifa

  • 1245.25.97009 Boehringer Ingelheim Investigational Site

    Holon

  • 1245.25.97005 Boehringer Ingelheim Investigational Site

    Nahariya

  • 1245.25.97001 Boehringer Ingelheim Investigational Site

    Safed

  • 1245.25.97002 Boehringer Ingelheim Investigational Site

    Tsrifin

Other trials in Israel

Mexico7 sites

  • 1245.25.52009 Boehringer Ingelheim Investigational Site

    Colonia Americana

  • 1245.25.52007 Boehringer Ingelheim Investigational Site

    Distrito Federal

  • 1245.25.52013 Boehringer Ingelheim Investigational Site

    Ladrón de Guevara

  • 1245.25.52010 Boehringer Ingelheim Investigational Site

    Los Robles

  • 1245.25.52001 Boehringer Ingelheim Investigational Site

    Monterrey

  • 1245.25.52011 Boehringer Ingelheim Investigational Site

    Reforma Social

  • 1245.25.52012 Boehringer Ingelheim Investigational Site

    San Lucas Tepetlcalco

Other trials in Mexico

Ukraine7 sites

  • 1245.25.75001 Boehringer Ingelheim Investigational Site

    Kharkiv

  • 1245.25.75008 Boehringer Ingelheim Investigational Site

    Kharkiv

  • 1245.25.75009 Boehringer Ingelheim Investigational Site

    Kharkiv

  • 1245.25.75011 Boehringer Ingelheim Investigational Site

    Kharkiv

  • 1245.25.75007 Boehringer Ingelheim Investigational Site

    Kiev

  • 1245.25.75012 Boehringer Ingelheim Investigational Site

    Kiev

  • 1245.25.75010 Boehringer Ingelheim Investigational Site

    Odesa

Other trials in Ukraine

Croatia6 sites

  • 1245.25.71005 Boehringer Ingelheim Investigational Site

    Karlovac

  • 1245.25.71001 Boehringer Ingelheim Investigational Site

    Krapinske Toplice

  • 1245.25.71006 Boehringer Ingelheim Investigational Site

    Osijek

  • 1245.25.71003 Boehringer Ingelheim Investigational Site

    Rijeka

  • 1245.25.71002 Boehringer Ingelheim Investigational Site

    Zagreb

  • 1245.25.71004 Boehringer Ingelheim Investigational Site

    Zagreb

Other trials in Croatia

Denmark6 sites

  • 1245.25.45007 Boehringer Ingelheim Investigational Site

    Elsinore

  • 1245.25.45006 Boehringer Ingelheim Investigational Site

    Frederiksberg

  • 1245.25.45003 Boehringer Ingelheim Investigational Site

    Gentofte Municipality

  • 1245.25.45002 Boehringer Ingelheim Investigational Site

    København NV

  • 1245.25.45004 Boehringer Ingelheim Investigational Site

    Randers NØ

  • 1245.25.45005 Boehringer Ingelheim Investigational Site

    Slagelse

Other trials in Denmark

Sri Lanka6 sites

  • 1245.25.94002 Boehringer Ingelheim Investigational Site

    Colombo

  • 1245.25.94005 Boehringer Ingelheim Investigational Site

    Kalubowila

  • 1245.25.94004 Boehringer Ingelheim Investigational Site

    Kandy

  • 1245.25.94006 Boehringer Ingelheim Investigational Site

    Kandy

  • 1245.25.94001 Boehringer Ingelheim Investigational Site

    Nugegoda

  • 1245.25.94003 Boehringer Ingelheim Investigational Site

    Ragama

Other trials in Sri Lanka

Thailand6 sites

  • 1245.25.66006 Boehringer Ingelheim Investigational Site

    Bangkok

  • 1245.25.66007 Boehringer Ingelheim Investigational Site

    Bangkok

  • 1245.25.66009 Boehringer Ingelheim Investigational Site

    Chiang Mai

  • 1245.25.66004 Boehringer Ingelheim Investigational Site

    Muang District

  • 1245.25.66010 Boehringer Ingelheim Investigational Site

    Nakhonratchasima

  • 1245.25.66011 Boehringer Ingelheim Investigational Site

    Pathum Tani

Other trials in Thailand

Estonia5 sites

  • 1245.25.37002 Boehringer Ingelheim Investigational Site

    Tallinn

  • 1245.25.37003 Boehringer Ingelheim Investigational Site

    Tallinn

  • 1245.25.37005 Boehringer Ingelheim Investigational Site

    Tallinn

  • 1245.25.37001 Boehringer Ingelheim Investigational Site

    Tartu

  • 1245.25.37004 Boehringer Ingelheim Investigational Site

    Tartu

Other trials in Estonia

Czechia4 sites

  • 1245.25.42020 Boehringer Ingelheim Investigational Site

    Brno

  • 1245.25.42018 Boehringer Ingelheim Investigational Site

    Jindřichův Hradec

  • 1245.25.42015 Boehringer Ingelheim Investigational Site

    Prague

  • 1245.25.42019 Boehringer Ingelheim Investigational Site

    Ústí nad Labem

Other trials in Czechia

Hong Kong4 sites

  • 1245.25.85201 Boehringer Ingelheim Investigational Site

    Hong Kong

  • 1245.25.85205 Boehringer Ingelheim Investigational Site

    Hong Kong

  • 1245.25.85207 Boehringer Ingelheim Investigational Site

    Hong Kong

  • 1245.25.85208 Boehringer Ingelheim Investigational Site

    Hong Kong

Other trials in Hong Kong

Australia3 sites

  • 1245.25.61001 Boehringer Ingelheim Investigational Site

    Ashford, South Australia

  • 1245.25.61002 Boehringer Ingelheim Investigational Site

    Fullarton, South Australia

  • 1245.25.61003 Boehringer Ingelheim Investigational Site

    Herston, Queensland

Other trials in Australia

New Zealand3 sites

  • 1245.25.64004 Boehringer Ingelheim Investigational Site

    Christchurch

  • 1245.25.64001 Boehringer Ingelheim Investigational Site

    Grafton / Auckland

  • 1245.25.64003 Boehringer Ingelheim Investigational Site

    Wellington

Other trials in New Zealand

Singapore3 sites

  • 1245.25.65001 Boehringer Ingelheim Investigational Site

    Singapore

  • 1245.25.65003 Boehringer Ingelheim Investigational Site

    Singapore

  • 1245.25.65004 Boehringer Ingelheim Investigational Site

    Singapore

Other trials in Singapore

About this study

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

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.

Being tested
BI 10773 low dose, Placebo BI 10773 high dose, BI 10773 high dose, Placebo BI 10773 low dose
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 10773 low doseDrug

    BI 10773 tablets once daily

  • Placebo BI 10773 high doseDrug

    Placebo tablets identical to BI 10773

  • BI 10773 high doseDrug

    BI 10773 tablets once daily

  • Placebo BI 10773 low doseDrug

    Placebo tablets identical to BI 10773

  • Placebo BI 10773 low doseDrug

    Placebo tablets identical to BI 10773

  • Placebo BI 10773 high doseDrug

    Placebo tablets identical to BI 10773

Study groups in NCT01131676
Study groupRoleWhat they receive
BI 10773 low doseExperimentalBI 10773 tablets once daily
Receives: Drug: BI 10773 low dose; Drug: Placebo BI 10773 high dose
BI 10773 high doseExperimentalBI 10773 tablets once daily
Receives: Drug: BI 10773 high dose; Drug: Placebo BI 10773 low dose
PlaceboPlacebo comparatorPlacebo tablets matching BI 10773
Receives: Drug: Placebo BI 10773 high dose; Drug: Placebo BI 10773 low dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 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.

    Measured: From randomisation to individual end of observation, up to 4.6 years

Secondary outcomes (6)

  1. 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

    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.

    Measured: From randomisation to individual end of observation, up to 4.6 years

  2. Percentage of Participants With Silent MI

    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.

    Measured: From randomisation to individual end of observation, up to 4.6 years

  3. Percentage of Participants With Heart Failure Requiring Hospitalisation (Adjudicated)

    Heart failure requiring hospitalisation (adjudicated). Percentage of patients with the event are presented.

    Measured: From randomisation to individual end of observation, up to 4.6 years

  4. Percentage of Participants With New Onset Albuminuria

    New onset albuminuria defined as urine albumin / creatinine ratio (UACR) ≥30 mg/g.

    Percentage of patients with the event are presented.

    Measured: From randomisation to individual end of observation, up to 4.6 years

  5. Percentage of Participants With New Onset Macroalbuminuria

    New onset macroalbuminuria defined as UACR >300 mg/g. Percentage of patients with the event are presented.

    Measured: From randomisation to individual end of observation, up to 4.6 years

  6. Percentage of Participants With the Composite Microvascular Outcome

    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.

    Measured: From randomisation to individual end of observation, up to 4.6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
7,064 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01131676
Sponsor's protocol ID
1245.25
Other IDs
2009-016178-33, 2009
Status last verified
Apr 2016
First submitted
26 May 2010
Last updated
16 May 2016

Publications

  • Heerspink HJL, Collier WH, Chaudhari J, Miao S, Tighiouart H, Appel GB, Caravaca-Fontan F, Floege J, Hannedouche T, Imai E, Jafar TH, Lewis JB, Li PKT, Locatelli F, Maes BD, Neuen BL, Perkovic V, Perrone RD, Remuzzi G, Schena FP, Wanner C, Greene T, Inker LA. A meta-analysis of albuminuria as a surrogate endpoint for kidney failure. Nat Med. 2026 Jan;32(1):281-287. doi: 10.1038/s41591-025-04057-z. Epub 2025 Nov 6.

    PubMed 41198855

  • Odutayo A, Zinman B, Wanner C, Zwiener I, Lund SS, Hantel S, Fitchett D, Udell JA; EMPA-REG OUTCOME Trial Investigators. Effect of Qualifying Atherosclerotic Cardiovascular Disease Diagnosis Proximity on Cardiovascular Risk and Benefit of Empagliflozin in the EMPA-REG OUTCOME Trial. CJC Open. 2024 Feb 9;6(7):868-875. doi: 10.1016/j.cjco.2024.01.013. eCollection 2024 Jul.

    PubMed 39026628

  • Fitchett D, Zinman B, Inzucchi SE, Wanner C, Anker SD, Pocock S, Mattheus M, Vedin O, Lund SS. Effect of empagliflozin on total myocardial infarction events by type and additional coronary outcomes: insights from the randomized EMPA-REG OUTCOME trial. Cardiovasc Diabetol. 2024 Jul 11;23(1):248. doi: 10.1186/s12933-024-02328-6.

    PubMed 38992713

  • Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

    PubMed 38770818

  • Hadjadj S, Cooper ME, Steubl D, Petrini M, Hantel S, Mattheus M, Wanner C, Thomas MC. Empagliflozin and Rapid Kidney Function Decline Incidence in Type 2 Diabetes: An Exploratory Analysis From the EMPA-REG OUTCOME Trial. Kidney Med. 2023 Dec 18;6(3):100783. doi: 10.1016/j.xkme.2023.100783. eCollection 2024 Mar.

    PubMed 38419787

  • Balasubramanian P, Kernan WN, Sheth KN, Ofstad AP, Rosenstock J, Wanner C, Zinman B, Mattheus M, Marx N, Inzucchi SE. Baseline Cardiovascular Risk Factor Control in Patients With Type 2 Diabetes and Coronary Disease Versus Stroke: Secondary Analysis of Cardiovascular Outcome Trials. Stroke. 2023 Aug;54(8):2013-2021. doi: 10.1161/STROKEAHA.122.042053. Epub 2023 Jul 14.

    PubMed 37449424

  • Dar MS, Wanner C, Marx N, Ofstad AP, Mattheus M, Kaspers S, Beg SA. Cardiovascular outcomes trial data from EMPA-REG OUTCOME, CAROLINA and CARMELINA: Assessment of a novel staging system for type 2 diabetes. Diabetes Obes Metab. 2023 May;25(5):1372-1384. doi: 10.1111/dom.14989. Epub 2023 Mar 6.

    PubMed 36700391

  • 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.

    PubMed 35472672

  • 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.

    PubMed 35166009

  • 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.

    PubMed 35005582

  • 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.

    PubMed 34752913

  • 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.

    PubMed 34558768

  • 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.

    PubMed 34463409

  • 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.

    PubMed 34325887

  • 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.

    PubMed 34129237

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI 10773 low dose and BI 10773 high dose in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 615 sites in 42 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 615 sites in United States, Brazil, Russia, Spain, South Africa and 37 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01131676, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in