Cascade 8

BI 10773 Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients

Cascade 8 [NCT01131676]

Description: 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.

Drug: BI 10773; Drug: placebo

Primary Investigator: Kereiakes

Drug/Device Information
Non inferiority trial of add on BI 10773 vs placebo in time to first cardiovascular event
BI 10773 is SGLT-2
Up to 4 year event trial
Major Inclusion and Exclusion
Type 2 DM with an cardiovascular risk
If drug naïve HbA1C must be ≥ 7 and ≤ 8
If currently on treatment HbA1C must be ≥ 7 and ≤ 10
Fasting blood sugar must be > 240 during study screen visits x 2