Insulin at normal physiological levels does not prolong QTc interval in thorough QT studies performed in healthy volunteers

Food is known to shorten the QTc (QTcI and QTcF) interval and has been proposed as a non‐pharmacological method of confirming assay sensitivity in thorough QT (TQT) studies and early phase studies in medicines research. Intake of food leads to a rise in insulin levels together with the release of C‐peptide in equimolar amounts. However, it has been reported that euglycaemic hyperinsulinemia can prolong the QTc interval, whilst C‐peptide has been reported to shorten the QTc interval. Currently there is limited information on the effects of insulin and C‐peptide on the electrocardiogram (ECG). This study was performed to assess the effect of insulin, glucose and C‐peptide on the QTc interval under the rigorous conditions of a TQT study.

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