Semaglutide and SNAC were measured by means of validated assays using plasma protein precipitation followed by liquid chromatography with tandem mass spectrometry detection as described previously [20]. The lower limit of quantification (LLOQ) was 0.73 nmol/L for semaglutide and 5.0 ng/mL for SNAC.
Safety assessments included AEs, hypoglycaemic episodes, laboratory safety parameters, physical examination, vital signs and ECG. Hypoglycaemic episodes were defined as ‘confirmed’ when they were either ‘severe’ according to the American Diabetes Association definition, i.e. requiring third party assistance [21], or verified by a plasma glucose level of less than 3.1 mmol/L.
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