Journal article
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
Journal of clinical pharmacology, v 49(11), pp 1353-1362
01 Nov 2009
PMID: 19737980
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
The objective of this study was to establish effects of liraglutide on the QTc interval. In this randomized, placebocontrolled, double-blind crossover study, 51 healthy participants were administered placebo, 0.6, 1.2, and 1.8 mg liraglutide once daily for 7 days each. Electro-cardiograms were recorded periodically over 24 hours at the end of placebo and highest dosing periods. Four different models for QT correction were used: QTci, as the primary endpoint, and QTciL, QTcF, and QTcB as secondary endpoints. 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. Moxifloxacin (400 mg) increased QTc intervals by 10.6 to 12.3 ms at 2 hours. There was no concentration-exposure dependency on QTc interval changes by liraglutide and no QTc thresholds above 500 ms or QTc increases >60 ms. The authors conclude that liraglutide caused no clinically relevant increases in the QTc interval.
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Details
- Title
- 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
- Creators
- Dhruba J. Chatterjee - Novo Nordisk (Denmark)Naum Khutoryansky - Novo Nordisk (Denmark)Milan Zdravkovic - Novo Nordisk (Denmark)Craig R. Sprenger - PRACS Institute, Ltd, Fargo, North DakotaJeffrey S. Litwin - ERT (Germany)
- Publication Details
- Journal of clinical pharmacology, v 49(11), pp 1353-1362
- Publisher
- Wiley
- Number of pages
- 10
- Grant note
- Novo Nordisk
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Engineering Technology
- Web of Science ID
- WOS:000270956500008
- Scopus ID
- 2-s2.0-70350430650
- Other Identifier
- 991019335603204721
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- Collaboration types
- International collaboration
- Web of Science research areas
- Pharmacology & Pharmacy