Effect of Liraglutide on Heart Frequency in Healthy Volunteers

Phase 1 Completed 64 enrolled Novo Nordisk A/S

RandomizedCrossoverDouble-blindTreatment

Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate if liraglutide effects the QTc interval. Moxifloxacin (Avelox®) is administered as positive control.

Timeline

Start: 2006-07
Primary completion: 2006-11
Completion: 2006-11

Outcome

Met primary endpoint

paper The upper bound of the 1-sided 95% confidence interval for time-matched, baseline-corrected, placebo-subtracted QTc intervals was <10 ms for all 4 correction methods. PMID 19737980 ↗

Publications

Results Chatterjee DJ, Khutoryansky N, Zdravkovic M, Sprenger CR, Litwin JS. Absence of QTc prolongation in a thorough QT study with subcutaneous liraglutide, a once-daily human GLP-1 analog for treatment of type 2 diabetes. J Clin Pharmacol. 2009 Nov;49(11):1353-62. doi: 10.1177/0091270009339189. Epub 2009 Sep 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Liraglutide	Peptide	1.8 mg	Subcutaneous
Comparator	Moxifloxacin	Small molecule	400 mg	—