A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM

Plasma glucose recovery is defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline during the hypoglycemic clamp procedure without administration of rescue intravenous glucose

Plasma glucose changes from baseline at 30 minutes, at 20 minutes, at 15 minutes, and at 10 minutes after trial drug injection or at the time of rescue patient level).

Area under the baseline-adjusted effect curve (AUE) from zero up to the concentration at 30 minutes, AUE 0-30min

Area under the baseline-adjusted effect curve (AUE) from zero up to the concentration at 90 minutes, AUE 0-90min

Change from baseline plasma glucose to maximum plasma glucose measure after dosing, CEmax

Time to maximum change in plasma glucose measure from baseline, TEmax

Area under the concentration-time curve (AUC) from zero up to the concentration at 30 minutes, AUC0-30min

Area under the concentration-time curve (AUC) from zero up to the concentration at 300 minutes, AUC0-300min

Area under the concentration-time curve from zero up to the concentration at infinitely after dosing, AUC0-inf

Measured maximum plasma drug concentration after dosing, Cmax

Sampling time until reaching Cmax, Tmax

Half-life dasiglucagon, t½

Apparent volume of distribution of dasiglucagon, Vz/f

Mean residence time, MRT

Total body clearance, CL/f

The incidence, type and severity of adverse events (AEs)

Number of rescue infusions of IV glucose after trial drug administration

Time to first rescue infusion of IV glucose after trial drug administration

Occurrence of antibodies against dasiglucagon