Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients
Enrollment: 660
Study Start Date: March 2009
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Arms:
- Active Comparator: Sitagliptin
- Active Comparator: Metformin
- Experimental: BI 10773 X mg
- Experimental: BI 10773 Y mg