Assessment of the Effect of Empagliflozin (BI 10773) as Single Dose on the QT Interval in Healthy Female and Male Subjects

NCT01195675 ↗

Phase 1 Completed 30 enrolled Boehringer Ingelheim

RandomizedCrossoverDouble-blindTreatment

Summary

The objective of this study is to demonstrate that BI 10773 does not prolong the QT(c) interval more than placebo

Timeline

Start: 2010-08
Primary completion: 2010-11
Completion: —

Outcome

Met primary endpoint

paper 0.6 (90% CI: -0.7, 1.9) ms and -0.2 (-1.4, 0.9) ms for empagliflozin 25 mg and 200 mg, respectively, below the ICH E14 defined threshold PMID 23617452 ↗

Publications

Ring A, Brand T, Macha S, Breithaupt-Groegler K, Simons G, Walter B, Woerle HJ, Broedl UC. The sodium glucose cotransporter 2 inhibitor empagliflozin does not prolong QT interval in a thorough QT (TQT) study. Cardiovasc Diabetol. 2013 Apr 24;12:70. doi: 10.1186/1475-2840-12-70.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Empagliflozin	Small molecule	25 mg	Oral
Subject	Empagliflozin	Small molecule	200 mg	Oral
Comparator	Moxifloxacin	Small molecule	400 mg	Oral

Indications

No indication recorded.