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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

From Novo Nordisk, Inc, Princeton, New Jersey (Dr Chatterjee, Dr Khutoryansky); Novo Nordisk A/S, Bagsvaerd, Denmark (Dr Zdravkovic); PRACS Institute, Ltd, Fargo, North Dakota (Dr Sprenger); and eResearchTechnology, Inc, Philadelphia, Pennsylvania (Dr Litwin).

The objective of this study was to establish effects of liraglutide on the QTc interval. In this randomized, placebo-controlled, 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. Electrocardiograms 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.

Key Words: Liraglutide • GLP-1 • QTc interval • drug safety

Address for reprints: Dhruba J. Chatterjee, PhD, Director, Clinical Research, Novo Nordisk, Inc, 100 College Road W., Princeton, NJ 08540; e-mail: dcee{at}novonordisk.com.

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