| Primary | Maximum Serum Insulin Aspart Concentration, CIAmax | Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. | Per Protocol Population for PK Analysis, defined as all participants who have received both study drugs during the study and are evaluable for both treatments. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg/mL | | Baseline (Time 0) to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0002961.8± 32.9
- OG0012827.4± 31.4
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Geometric Mean Ratio | 104.7 | | | 2-Sided | 90 | 100.0 | 109.7 | | | | | Equivalence | The geometric mean ratio and confidence intervals of the primary analyses should meet FDA bioequivalence requirements: the 90% confidence interval is within 80.00 - 125.00%. | |
|
| 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 from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. AUCIA(0-12h) will be calculated from the concentration curves. Only AUC from 0 to 12 hours (AUCIA(0-12h)) is reported. | Per Protocol Population for PK Analysis, defined as all participants who have received both study drugs during the study and are evaluable for both treatments. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg/mL * hr | | 0 to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
| |
| 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. | Per Protocol Population for PD Analysis, defined as all participants who meet all of the following four (4) criteria for both treatments: 1) correct dose and administration; 2) more than 90% per minute GIR records are available; 3) clamp precision is less than 12%; and 4) clamp deviation from target (DFT) is less than 12%. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg/kg/min | | From drug administration to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
| |
| 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. Because GIR is recorded in mg/kg/min, the area under the GIR-time curve has units mg/kg. | Per Protocol Population for PD Analysis, defined as all participants who meet all of the following four (4) criteria for both treatments: 1) correct dose and administration; 2) more than 90% per minute GIR records are available; 3) clamp precision is less than 12%; and 4) clamp deviation from target (DFT) is less than 12%. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg/kg | | From drug administration to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
|
| Secondary | Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to Infinity, AUCIA(0-∞) | Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. AUCIA(0-∞) will be calculated from the concentration curves. AUCIA(0-∞) is derived using standard extrapolation beyond the last measurable concentration. | Per Protocol Population for PK Analysis, defined as all participants who have received both study drugs during the study and are evaluable for both treatments. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg/mL * hr | | 0 to infinity (extrapolated; concentrations measured through 12 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
| |
| Secondary | Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 1 Hour Post-dose, AUCIA(0-1h) | Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. AUCIA(0-1h) will be calculated from the concentration curves. Only AUC from 0 to 1 hour (AUCIA(0-1h)) is reported. | Per Protocol Population for PK Analysis, defined as all participants who have received both study drugs during the study and are evaluable for both treatments. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg/mL * hr | | 0 to 1 hour post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
| |
| 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 from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. AUCIA(0-2h) will be calculated from the concentration curves. Only AUC from 0 to 2 hours (AUCIA(0-2h)) is reported. | Per Protocol Population for PK Analysis, defined as all participants who have received both study drugs during the study and are evaluable for both treatments. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg/mL * hr | | 0 to 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
| |
| Secondary | Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 4 Hours Post-dose, AUCIA(0-4h) | Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. AUCIA(0-4h) will be calculated from the concentration curves. Only AUC from 0 to 4 hours (AUCIA(0-4h)) is reported. | Per Protocol Population for PK Analysis, defined as all participants who have received both study drugs during the study and are evaluable for both treatments. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg/mL * hr | | 0 to 4 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
| |
| Secondary | Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From 4 to 12 Hours Post-dose, AUCIA(4-12h) | Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. AUCIA(4-12h) will be calculated from the concentration curves. Only AUC from 4 to 12 hours (AUCIA(4-12h)) is reported. | Per Protocol Population for PK Analysis, defined as all participants who have received both study drugs during the study and are evaluable for both treatments. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg/mL * hr | | 4 to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
| |
| Secondary | Time of Maximum Insulin Aspart Serum Concentration, tIAmax | Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. | Per Protocol Population for PK Analysis, defined as all participants who have received both study drugs during the study and are evaluable for both treatments. | Posted | | Median | Full Range | min | | Baseline (Time 0) to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
| |
| Secondary | Apparent Clearance of Insulin Aspart, CL/F | Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. | Per Protocol Population for PK Analysis, defined as all participants who have received both study drugs during the study and are evaluable for both treatments. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/hr | | Baseline (Time 0) to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
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| Secondary | Apparent Volume of Distribution of Insulin Aspart, Vz/F | Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. | Per Protocol Population for PK Analysis, defined as all participants who have received both study drugs during the study and are evaluable for both treatments. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L | | Baseline (Time 0) to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
| |
| Secondary | Half-life of Insulin Aspart, t1/2 | Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Insulin Aspart. | Per Protocol Population for PK Analysis, defined as all participants who have received both study drugs during the study and are evaluable for both treatments. | Posted | | Median | Full Range | min | | Baseline (Time 0) to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
| |
| Secondary | Maximum Serum Human Insulin Concentration, CHImax | Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Human Insulin | Per Protocol Population for PK Analysis, defined as all participants who have received both study drugs during the study and are evaluable for both treatments. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg/mL | | Baseline (Time 0) to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
| |
| Secondary | 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 from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Human Insulin. AUCHI(0-12h) will be calculated from the concentration curves. Only AUC from 0 to 12 hours (AUCHI(0-12h)) is reported. | Per Protocol Population for PK Analysis, defined as all participants who have received both study drugs during the study and are evaluable for both treatments. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg/mL * hr | | 0 to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
| |
| Secondary | Time of Maximum Human Insulin Serum Concentration, tHImax | Pharmacokinetic (PK) blood samples will be collected from 60 minutes before dose through 12 hours post-dose. Serum will be isolated for analyzing the concentrations of Human Insulin. | Per Protocol Population for PK Analysis, defined as all participants who have received both study drugs during the study and are evaluable for both treatments. | Posted | | Median | Full Range | min | | Baseline (Time 0) to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
| |
| 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. Because GIR is recorded in mg/kg/min, the area under the GIR-time curve has units mg/kg. | Per Protocol Population for PD Analysis, defined as all participants who meet all of the following four (4) criteria for both treatments: 1) correct dose and administration; 2) more than 90% per minute GIR records are available; 3) clamp precision is less than 12%; and 4) clamp deviation from target (DFT) is less than 12%. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg/kg | | From drug administration to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
|
| 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. | Per Protocol Population for PD Analysis, defined as all participants who meet all of the following four (4) criteria for both treatments: 1) correct dose and administration; 2) more than 90% per minute GIR records are available; 3) clamp precision is less than 12%; and 4) clamp deviation from target (DFT) is less than 12%. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg/kg/min | | From drug administration to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
|
| Secondary | Area Under the Curve (AUC) for Glucose Infusion Rate (GIR) From Time 0 to the Time of Last Measurable 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. Because GIR is recorded in mg/kg/min, the area under the GIR-time curve has units mg/kg. | Per Protocol Population for PD Analysis, defined as all participants who meet all of the following four (4) criteria for both treatments: 1) correct dose and administration; 2) more than 90% per minute GIR records are available; 3) clamp precision is less than 12%; and 4) clamp deviation from target (DFT) is less than 12%. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg/kg | | From drug administration to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
|
| Secondary | Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 1 Hour Post-dose, AUCG(0-1h) | 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(0-1h) will be calculated from the glucose infusion rate curves. Because GIR is recorded in mg/kg/min, the area under the GIR-time curve has units mg/kg. | Per Protocol Population for PD Analysis, defined as all participants who meet all of the following four (4) criteria for both treatments: 1) correct dose and administration; 2) more than 90% per minute GIR records are available; 3) clamp precision is less than 12%; and 4) clamp deviation from target (DFT) is less than 12%. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg/kg | | From drug administration to 1 hour post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
|
| 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. Because GIR is recorded in mg/kg/min, the area under the GIR-time curve has units mg/kg. | Per Protocol Population for PD Analysis, defined as all participants who meet all of the following four (4) criteria for both treatments: 1) correct dose and administration; 2) more than 90% per minute GIR records are available; 3) clamp precision is less than 12%; and 4) clamp deviation from target (DFT) is less than 12%. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg/kg | | From drug administration to 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
|
| Secondary | Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 4 Hours Post-dose, AUCG(0-4h) | 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(0-4h) will be calculated from the glucose infusion rate curves. Because GIR is recorded in mg/kg/min, the area under the GIR-time curve has units mg/kg. | Per Protocol Population for PD Analysis, defined as all participants who meet all of the following four (4) criteria for both treatments: 1) correct dose and administration; 2) more than 90% per minute GIR records are available; 3) clamp precision is less than 12%; and 4) clamp deviation from target (DFT) is less than 12%. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg/kg | | From drug administration to 4 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
|
| Secondary | Area Under the Curve (AUC) for Glucose Infusion Rate From Time 4 to 12 Hours Post-dose, AUCG(4-12h) | 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(4-12h) will be calculated from the glucose infusion rate curves. Because GIR is recorded in mg/kg/min, the area under the GIR-time curve has units mg/kg. | Per Protocol Population for PD Analysis, defined as all participants who meet all of the following four (4) criteria for both treatments: 1) correct dose and administration; 2) more than 90% per minute GIR records are available; 3) clamp precision is less than 12%; and 4) clamp deviation from target (DFT) is less than 12%. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg/kg | | From 4 hours post-dose to 12 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
|
| Secondary | Last Measurable 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. | Per Protocol Population for PD Analysis, defined as all participants who meet all of the following four (4) criteria for both treatments: 1) correct dose and administration; 2) more than 90% per minute GIR records are available; 3) clamp precision is less than 12%; and 4) clamp deviation from target (DFT) is less than 12%. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg/kg/min | | From drug administration to 12 hours post-dose | | | | ID | Title | Description |
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| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
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| 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. | Per Protocol Population for PD Analysis, defined as all participants who meet all of the following four (4) criteria for both treatments: 1) correct dose and administration; 2) more than 90% per minute GIR records are available; 3) clamp precision is less than 12%; and 4) clamp deviation from target (DFT) is less than 12%. | Posted | | Median | Full Range | min | | From drug administration to 12 hours post-dose | | | | ID | Title | Description |
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| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
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| 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. | Per Protocol Population for PD Analysis, defined as all participants who meet all of the following four (4) criteria for both treatments: 1) correct dose and administration; 2) more than 90% per minute GIR records are available; 3) clamp precision is less than 12%; and 4) clamp deviation from target (DFT) is less than 12%. | Posted | | Median | Full Range | min | | From drug administration to 12 hours post-dose | | | | ID | Title | Description |
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| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
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| Secondary | Time of Last Measurable 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. | Per Protocol Population for PD Analysis, defined as all participants who meet all of the following four (4) criteria for both treatments: 1) correct dose and administration; 2) more than 90% per minute GIR records are available; 3) clamp precision is less than 12%; and 4) clamp deviation from target (DFT) is less than 12%. | Posted | | Median | Full Range | min | | From drug administration to 12 hours post-dose | | | | ID | Title | Description |
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| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
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| 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. | Per Protocol Population for PD Analysis, defined as all participants who meet all of the following four (4) criteria for both treatments: 1) correct dose and administration; 2) more than 90% per minute GIR records are available; 3) clamp precision is less than 12%; and 4) clamp deviation from target (DFT) is less than 12%. | Posted | | Median | Full Range | min | | From drug administration to 12 hours post-dose | | | | ID | Title | Description |
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| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
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| 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. | Per Protocol Population for PD Analysis, defined as all participants who meet all of the following four (4) criteria for both treatments: 1) correct dose and administration; 2) more than 90% per minute GIR records are available; 3) clamp precision is less than 12%; and 4) clamp deviation from target (DFT) is less than 12%. | Posted | | Median | Full Range | min | | From drug administration to 12 hours post-dose | | | | ID | Title | Description |
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| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
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| Other Pre-specified | Systolic Blood Pressure (SBP) | Participant vital signs were measured in a supine position, after a 5-minute resting period, before drug administration (baseline) and at specified time points after dosing. | Treated Population: all subjects who have received any amount of the study drug treatment. | Posted | | Mean | Standard Deviation | mmHg | | Baseline (15 minutes pre-dose), 5 minutes, 60 minutes, 180 minutes, and 720 minutes post-dose | | | | ID | Title | Description |
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| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
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| Other Pre-specified | Diastolic Blood Pressure (DBP) | Participant vital signs were measured in a supine position, after a 5-minute resting period, before drug administration (baseline) and at specified time points after dosing. | Treated Population: all subjects who have received any amount of the study drug treatment. | Posted | | Mean | Standard Deviation | mmHg | | Baseline (15 minutes pre-dose), 5 minutes, 60 minutes, 180 minutes, and 720 minutes post-dose | | | | ID | Title | Description |
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| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
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| Other Pre-specified | Heart Rate (HR) | Participant vital signs were measured in a supine position, after a 5-minute resting period, before drug administration (baseline) and at specified time points after dosing. | Treated Population: all subjects who have received any amount of the study drug treatment. | Posted | | Mean | Standard Deviation | bpm | | Baseline (15 minutes pre-dose), 5 minutes, 60 minutes, 180 minutes, and 720 minutes post-dose | | | | ID | Title | Description |
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| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
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| Other Pre-specified | QT Interval | A standard 12-lead electrocardiogram (ECG) was recorded in a supine position, after a 5 minute resting period, before drug administration (baseline) and at specified time points after dosing. | Treated Population: all subjects who have received any amount of the study drug treatment. | Posted | | Mean | Standard Deviation | ms | | Baseline (15 minutes pre-dose), 5 minutes, 60 minutes, 180 minutes, and 720 minutes post-dose | | | | ID | Title | Description |
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| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
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| Other Pre-specified | Corrected QT (QTc-F) Interval | A standard 12-lead electrocardiogram (ECG) was recorded in a supine position, after a 5 minute resting period, before drug administration (baseline) and at specified time points after dosing. QT interval was corrected using the Fridericia correction. | Treated Population: all subjects who have received any amount of the study drug treatment. | Posted | | Mean | Standard Deviation | ms | | Baseline (15 minutes pre-dose), 5 minutes, 60 minutes, 180 minutes, and 720 minutes post-dose | | | | ID | Title | Description |
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| OG000 | Insulin Aspart, I004 | Participants who were dosed with I004 I004: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. | | OG001 | NovoLog | Participants who were dosed with NovoLog NovoLog: Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition. |
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