Phase 1 Completed N=30 Randomized Double-blind Treatment

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

Healthy

Source: ClinicalTrials.gov NCT01195675 ↗

Enrolled (actual)

Serious AEs

0.9%

Results posted

Jul 2014

Primary outcomePrimary: Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing — 3.68; 4.27 ms

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing	3.68; 4.27	—
PRIMARY Empa 200mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing	3.67; 3.44	—
SECONDARY Empa 25 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing	0.71; 1.37	—
SECONDARY Empa 200 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing	0.68; 0.53	—
SECONDARY Mean QTcN Change From Baseline Between 2 and 4 Hours After Dosing	3.53; 15.96	<0.0001 sig
SECONDARY Empa 25mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings	-4.46; -2.30	—
SECONDARY Empa 200mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings	3.05; 4.64	—

Eligibility Criteria

Inclusion criteria

healthy female and male subjects

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01195675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.