A Phase III Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 10773 Compared to Glimepiride Administered Orally During 104 Weeks With a 104 Week Extension Period in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Metformin Treatment
A Phase III Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 10773 Compared to Glimepiride Administered Orally During 104 Weeks With a 104 Week Extension Period in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Metformin Treatment
This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.
Inclusion criteria:
Exclusion criteria:
Bradednton, Florida, United States
Capital Federal, Argentina
Grand Falls-Windsor, Newfoundland and Labrador, Canada
Mount Pearl, Newfoundland and Labrador, Canada
St. John's, Newfoundland and Labrador, Canada
Uttar Pradesh, India
Kelantan, Malaysia
Selangor Darul Ehsan, Malaysia
Jaro Iloilo City, Philippines
Tagbilaran City, Bohol, Philippines
Lenasia South, South Africa
Burjasot, Spain
Tarrega - Lleida, Spain
Tainan Hsien, Taiwan
Taipei Hsien, Taiwan
Muang District, Thailand
Nakhonratchasima, Thailand
Barnstable, United Kingdom
Chestfield, Whitstable, United Kingdom