Empagliflozin for type 2 diabetes mellitus - National Horizon ...

April 2012
effects
(AEs)
Expected
reporting
date
sitagliptin, respectively: frequent
urination, 2.5% vs 1.4% vs 0%; urinary
tract infection, 4.0% vs 2.8% vs 4.2%;
gential infection, 4.0% vs 0% vs 2.8%;
hypoglycaemia, 1.1% vs 0% vs 2.8%.
urination, thirst and nasopharyngitis. Rates of
hypoglycaemia similar between groups. Low
incidence of genital infections and urinary
tract infections.
Previously reported as Oct 2009. Previously reported as Oct 2009.
Trial NCT00881530, 2008-007938-21, 1245.24; adults; empagliflozin vs sitagliptin vs
metformin; phase II extension.
Sponsor Boehringer Ingelheim Pharmaceuticals.
Status Completed but unpublished.
Source of
information
Trial registry 34 .
Location EU, USA and other countries.
Design Randomised, active-controlled.
Participants
and schedule
n=660 (planned); adults; type 2 diabetes; completed trial NCT00789035 or
NCT00749190.
Randomised to empagliflozin 10mg or 25mg, oral once daily; or sitagliptin 100mg, oral
once daily; or metformin, 2,000mg, oral daily.
Follow-up Active treatment period 78 weeks.
Primary Safety; AEs; hypoglycaemic events; use of rescue therapy; vital signs; body weight;
outcomes waist circumference; lipid parameters; clinical laboratory changes.
Secondary HbA1c; % treated to target