A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 10773 and Sitagliptin Administered Orally Over 24 Weeks, in Drug naïve Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Diet and Exercise
A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 10773 and Sitagliptin Administered Orally Over 24 Weeks, in Drug naïve Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Diet and Exercise
The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.
Inclusion criteria:
Exclusion criteria:
Mount Pearl, Newfoundland and Labrador, Canada
St. John's, Newfoundland and Labrador, Canada
Saint Ingbert/Oberwürzbach, Germany
Schauenburg, Germany
Tamil Nadu, India
Co. Cork, Ireland
Co. Galway, Ireland
Co. Wexford, Ireland
Offaly, Ireland
Chuo-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Kamakura, Kanagawa, Japan
Minato-ku, Tokyo, Japan
Suita, Osaka, Japan
Ube, Yamaguchi, Japan
Urasoe, Okinawa, Japan
Urasoe, Okinawa, Japan