Rel. BA of Empagliflozin (BI 10773)/Linagliptin FDC Tbl, Comparison With Mono-components, With a Second FDC Tablet and Influence of Food
Completed
Boehringer Ingelheim
Phase 1
2010-08-01
The primary objective of the current study is to investigate the relative bioavailability of
BI 10773 / linagliptin fixed dose combination tablet (formulation A1, Treatment A, Test)
compared to BI 10773 given in free combination with linagliptin (Treatment B, Reference),
both in the fasting state. All 42 subjects entered are planned to be included in this
comparison.
The secondary objective is to investigate the relative bioavailability of BI 10773 /
linagliptin fixed dose combination tablet after administration of a standardised high fat,
high caloric meal (formulation A1, Treatment C, Test) compared to BI 10773 / linagliptin
fixed dose combination in the fasting state (formulation A1,Treatment A, Reference). Of the
42 subjects entered 18 subjects are planned to be included in this comparison.
An additional objective is to investigate the relative bioavailability of a second
formulation of the fixed dose combination tablet of BI 10773 / linagliptin (formulation
A3,Treatment D, Test) compared to BI 10773 / linagliptin fixed dose combination tablet
(formulation A1,Treatment A, Reference). Of the 42 subjects entered 24 subjects are planned
to be included in this comparison.
Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
Completed
Eli Lilly and Company
Phase 3
2011-08-01
This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination
(FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to
support approval by regulatory authorities.
Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
Completed
Boehringer Ingelheim
Phase 3
2011-08-01
This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination
(FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to
support approval by regulatory authorities.
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