Parameter, mean (SD)* | During URTI | Post-URTI | Comparison (during URTI−post-URTI) | p Value |
---|---|---|---|---|
FDKP AUC0–240 min, ng min/mL | 23 315 (12 586) | 26 763 (14 782) | ||
FDKP ratio AUC0–240 min during URTI: AUC0–240 min post-URTI | NA | NA | 1.1 (0.63)†,‡ | 0.4462 |
FDKP tmax, min | 15.8 (26.2)† | 15.5 (14.8)† | −0.3 (31.98)† | 0.9725 |
FDKP t½, min | 163.2 (35.5)† | 174.8 (79.0)† | −15.4 (62.6)† | 0.3105 |
Plasma glucose Cmax, mg/dL | 212.0 (65.6) | 198.8 (69.7) | −13.2 (75.6)§ | NA |
Baseline-corrected plasma glucose Cmax, mg/dL | 81.0 (57.2) | 69.7 (69.9) | −11.3 (72.7)§ | NA |
Plasma glucose Cmin, mg/dL | 116.7 (41.7) | 111.1 (41.2) | −5.7 (57.8)§ | NA |
Baseline-corrected plasma glucose Cmin, mg/dL | 5.9 (14.6) | 1.9 (7.9) | −4.0 (12.5)§ | NA |
Serum insulin ratio AUC0–240 min during URTI: AUC0–240 min post-URTI | NA | NA | 0.9 (0.37)‡ | 0.1754 |
Serum insulin tmax, min | 25.5 (44.42) | 21.3 (25.12) | −4.3 (52.12) | 0.7194 |
AUC was normalized for these participants to the lower of the two doses; the ratio was performed on the log-transformed normalized AUC.
*Across the study, insulin doses were individualized and ranged from 15 to 90 units; therefore, calculating mean FDKP and insulin AUC or mean insulin and C-peptide concentrations or PK parameters is not meaningful.
†n=19.
‡For five participants, doses between the two arms were different.
§Since differences were small and the variation was large, statistical analysis was limited.
AUC, area under the concentration; AUC0–240 min, area under the concentration–time curve from 0 to 240 min; FDKP, fumaryl diketopiperazine; NA, not applicable; PK, pharmacokinetic; URTI, upper respiratory tract infection.