Quality assessments of clamp test
±
The baseline serum C-peptide level was defined as the arithmetic mean of serum C-peptide concentrations measured at -120, -90, -60, -30, and 0 min before drug administration. The mean of serum C-peptide levels and the changes from baseline in T group and R group were respectively calculated at the following time points: 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 150, 120, 180, 210, 240, 270, 300, 330, 360, 420, and 480 min after drug administration. After administration, the means of serum C-peptide levels (mean ± SD) of subjects in the T group and R group were 126.77 ± 49.619 and 130.17 ± 67.753, respectively. The ratios of the mean serum C-peptide value to baseline in the two groups were 32.6% and 33.2%, respectively. After the subjects were in a stable state, C peptide levels in both groups were lower than 50% of the baseline levels, which verified that the dominant insulin concentration achieved by exogenous intravenous infusion had inhibited the production of endogenous insulin in subjects. The euglycemic clamp platform was stable (Mean concentration-time curves for serum C-peptide (pmol/L) at specified time points (PK concentration set). T, study drug, 300 IU, p.o.; R, reference drug, 0.1 IU/Kg, i.h.Concentration-time curves for serum glucose (mmol/L) at specified time points. T, study drug, 300 IU, p.o.; R, reference drug, 0.1 IU/Kg, i.h.