Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Maximum Serum Insulin Aspart Concentration, CIAmax |
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose and until 12 hours after dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart |
From 60 minutes before dose until 12 hours after dose |
|
Primary |
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration from time 0 to 12 hours post-dose, AUCIA(0-12h) |
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose and until 12 hours after dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. AUCIA(0-12h) will be calculated from the concentration curves. |
From 60 minutes before dose until 12 hours after dose |
|
Primary |
Maximum Serum Human Insulin Concentration, CHImax |
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose and until 12 hours after dose. Serum will be isolated for analyzing the concentrations of Human Insulin |
From 60 minutes before dose until 12 hours after dose |
|
Primary |
Area Under the Curve (AUC) of Human Insulin Serum Concentration from time 0 to 12 hours post-dose, AUCHI(0-12h) |
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose and until 12 hours after dose. Serum will be isolated for analyzing the concentrations of Human Insulin. AUCHI(0-12h) will be calculated from the concentration curves. |
From 60 minutes before dose until 12 hours after dose |
|
Primary |
Maximum Glucose Infusion Rate, Gmax |
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. |
From drug administration until 12 hours after dose |
|
Primary |
Area Under the Curve (AUC) for Glucose Infusion Rate from time 0 to 12 hours post-dose, AUCG(0-12h) |
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. AUCG(0-12h) will be calculated from the glucose infusion rate curves. |
From drug administration until 12 hours after dose |
|
Secondary |
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration from time 0 to infinity, AUCIA(0-8) |
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose and until 12 hours after dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. AUCIA(0-8) will be calculated from the concentration curves. |
From 60 minutes before dose until 12 hours after dose |
|
Secondary |
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration from time 0 to 2 hours post-dose, AUCIA(0-2h) |
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose and until 12 hours after dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. AUCIA(0-2h) will be calculated from the concentration curves. |
From 60 minutes before dose until 2 hours after dose |
|
Secondary |
Time of Maximum Insulin Aspart Serum Concentration, tIAmax |
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose and until 12 hours after dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. |
From 60 minutes before dose until 12 hours after dose |
|
Secondary |
Apparent Clearance of Insulin Aspart, CL/F |
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose and until 12 hours after dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. |
From 60 minutes before dose until 12 hours after dose |
|
Secondary |
Apparent Volume of Distribution of Insulin Aspart, Vz/F |
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose and until 12 hours after dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. |
From 60 minutes before dose until 12 hours after dose |
|
Secondary |
Half-life of Insulin Aspart, t1/2 |
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose and until 12 hours after dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. |
From 60 minutes before dose until 12 hours after dose |
|
Secondary |
Time of Maximum Human Insulin Serum Concentration, tHImax |
Pharmacokinetic (PK) blood samples will be collected starting 60 minutes before dose and until 12 hours after dose. Serum will be isolated for analyzing the concentrations of Human Insulin. |
From 60 minutes before dose until 12 hours after dose |
|
Secondary |
Area Under the Curve (AUC) for Glucose Infusion Rate due to Insulin Aspart from time 0 to 12 hours post-dose, AUCGA(0-12h) |
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. AUCGA(0-12h) will be calculated from the glucose infusion rate curves. |
From drug administration until 12 hours after dose |
|
Secondary |
Maximum Glucose Infusion Rate due to Insulin Aspart, GAmax |
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. |
From drug administration until 12 hours after dose |
|
Secondary |
Area Under the Curve (AUC) for Glucose Infusion Rate (GIR) from time 0 to the Time of Last Measureable GIR, AUCG(0-last) |
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. AUCG(0-last) will be calculated from the glucose infusion rate curves. |
From drug administration until 12 hours after dose |
|
Secondary |
Area Under the Curve (AUC) for Glucose Infusion Rate from time 0 to 2 hours post-dose, AUCG(0-2h) |
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. AUCG(0-2h) will be calculated from the glucose infusion rate curves. |
From drug administration until 2 hours after dose |
|
Secondary |
Last Measureable Glucose Infusion Rate, Glast |
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. |
From drug administration until 12 hours after dose |
|
Secondary |
Time of Maximum Glucose Infusion Rate, tGmax |
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. |
From drug administration until 12 hours after dose |
|
Secondary |
Time of Glucose Infusion Start, tGonset |
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. |
From drug administration until 12 hours after dose |
|
Secondary |
Time of Last Measureable Glucose Infusion Rate, tGlast |
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. |
From drug administration until 12 hours after dose |
|
Secondary |
Time to Half of Maximum Glucose Infusion Rate (Gmax) Before Gmax Is Reached, tG50%early |
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. |
From drug administration until 12 hours after dose |
|
Secondary |
Time to Half of Maximum Glucose Infusion Rate (Gmax) After Gmax Is Reached, tG50%late |
Participants will undergo a euglycemic clamp, where blood glucose concentration will be held at a constant target level by adjusting exogenous glucose infusion rate (GIR) following drug administration. GIR will be recorded for the duration of the euglycemic clamp and used to evaluate the Pharmacodynamic (PD) response. |
From drug administration until 12 hours after dose |
|