Table 1 Demographics of subjects and index to estimate the quality of euglycemic clamps.

From: Similar pharmacokinetics and pharmacodynamics of a new biosimilar and reference insulin aspart in healthy Chinese males

 

RD10046

N = 30

NovoRapid

N = 30

P

Demographics of subjects

Age (year)a

24.7 ± 2.89

24.7 ± 2.89

–

Weight (kg)a

63.5 ± 5.87

63.6 ± 5.84

0.97

BMI (kg/m2)a

21.6 ± 1.40

21.6 ± 1.43

0.95

Quality control index

Target of BG (mmol/L)a

4.33 ± 0.31

4.35 ± 0.27

0.93

‘Clamped’ BG (mmol/L)a

4.36 ± 0.26

4.34 ± 0.23

0.70

Basal C-peptide (pmol/L)a

300 ± 83.7

288 ± 71.0

0.52

Postdosing C-peptide (pmol/L)a

206 ± 63.3

200 ± 63.0

0.64

C-peptide suppression after injection (%)a

30.2 ± 14.7

30.7 ± 13.3

0.89

CVBG (%)a

4.13 ± 0.99

4.03 ± 0.82

0.68

MARD at target BG level (%)a,b

3.56 ± 1.00

3.38 ± 0.75

0.43

  1. BMI body mass index, CVBG coefficient of variation of blood glucose, BG blood glucose, MARD mean absolute relative difference.
  2. aMean ± SD.
  3. bMARD at the target BG level (%): 100 ×|(clamped BG − target BG)/target BG|.
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