A Phase III, multicentre, international, randomized, parallel group, double-blind cardiovascular safety study of BI 10733 (10mg and 25mg) administered orally once daily compared to usual care in type 2 diabetes mellitus patients with increased cardiovascular risk.

Inclusion criteria

  • Men or women, age 18 and over with type 2 diabetes with heart disease such as angina, heart attack, stroke or circulation problems etc. 
  • can be on no medications currently or one or more diabetes medications --HbA1c equal to or greater than 7% but less than or equal to 10% if on medication for diabetes currently --HbA1c equal to or greater than 7% but less than or equal to 8% if on no medication for diabetes currently

Institutions involved

Mount Sinai Hospital and worldwide

Investigator involved

Dr. Zinman Funding source: Boehringer Ingelheim

Inclusion criteria

Mount Sinai Hospital Brief abstract of project and relevance: BI 10773 is in a class of drugs called SGLT-2 inhibitors.  They act in the kidney to let sugar spill out in the urine sooner than it normally would.  This action helps lower the blood sugar in the body by getting rid of it leading to better diabetes control.  The purpose of the study is to compare two different doses of BI 10773 (10mg and 25mg) vs placebo (a pill with no action) in addition to usual care in people with type 2 diabetes who have existing cardiovascular problems to demonstrate non-inferiority.  We will be studying 4,000 people worldwide.

Rationale for posting

For recruitment

Ethical approval

Mount Sinai Hospital Research Ethics Board

Project start date

Already underway

Project end date

Approximately 4 years

Contact information

For more information and eligibility requirements, please contact Stella skink@mtsinai.on.ca or Paula pvannostrand@mtsinai.on.ca or call 416-586-8775 or visit our website at http://www.mountsinai.on.ca/care/lscd/research-studies.