Trial Outcomes & Findings for Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers (NCT NCT05539872)
NCT ID: NCT05539872
Last Updated: 2026-03-05
Results Overview
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.
COMPLETED
PHASE2/PHASE3
69 participants
Baseline (Time 0) to 12 hours post-dose
2026-03-05
Participant Flow
Participants were randomized to receive all 2 treatments over 2 treatment periods in a crossover design.
Participant milestones
| Measure |
Treatment T - Treatment R
Participants received one of the two treatments during each study visit. Visit 1: Treatment T: Subcutaneous injection of I004 (Insulin Aspart) 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.; Visit 2: Treatment R: Subcutaneous injection of NovoLog (Insulin Aspart) 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.
|
Treatment R - Treatment T
Participants received one of the two treatments during each study visit. Visit 1: Treatment R: Subcutaneous injection of NovoLog (Insulin Aspart) 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.; Visit 2: Treatment T: Subcutaneous injection of I004 (Insulin Aspart) 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.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
35
|
34
|
|
Treatment Period 1
COMPLETED
|
35
|
34
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period 1 (7-21 Days)
STARTED
|
35
|
34
|
|
Washout Period 1 (7-21 Days)
COMPLETED
|
32
|
30
|
|
Washout Period 1 (7-21 Days)
NOT COMPLETED
|
3
|
4
|
|
Treatment Period 2
STARTED
|
32
|
30
|
|
Treatment Period 2
COMPLETED
|
32
|
28
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Treatment T - Treatment R
Participants received one of the two treatments during each study visit. Visit 1: Treatment T: Subcutaneous injection of I004 (Insulin Aspart) 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.; Visit 2: Treatment R: Subcutaneous injection of NovoLog (Insulin Aspart) 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.
|
Treatment R - Treatment T
Participants received one of the two treatments during each study visit. Visit 1: Treatment R: Subcutaneous injection of NovoLog (Insulin Aspart) 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.; Visit 2: Treatment T: Subcutaneous injection of I004 (Insulin Aspart) 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.
|
|---|---|---|
|
Washout Period 1 (7-21 Days)
Adverse Event
|
0
|
1
|
|
Washout Period 1 (7-21 Days)
Lost to Follow-up
|
1
|
0
|
|
Washout Period 1 (7-21 Days)
Withdrawal by Subject
|
2
|
2
|
|
Washout Period 1 (7-21 Days)
Subject Unreachable
|
0
|
1
|
|
Treatment Period 2
Adverse Event
|
0
|
1
|
|
Treatment Period 2
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Intent To Treat Population
n=69 Participants
All participants who were randomized
|
|---|---|
|
Age, Continuous
|
39.6 years
STANDARD_DEVIATION 11.7 • n=41 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
White
|
43 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
13 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Baseline (Time 0) to 12 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=58 Participants
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.
|
NovoLog
n=58 Participants
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.
|
|---|---|---|
|
Maximum Serum Insulin Aspart Concentration, CIAmax
|
2961.8 pg/mL
Geometric Coefficient of Variation 32.9
|
2827.4 pg/mL
Geometric Coefficient of Variation 31.4
|
PRIMARY outcome
Timeframe: 0 to 12 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=58 Participants
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.
|
NovoLog
n=58 Participants
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.
|
|---|---|---|
|
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 12 Hours Post-dose, AUCIA(0-12h)
|
7215.0 pg/mL * hr
Geometric Coefficient of Variation 26.0
|
6976.9 pg/mL * hr
Geometric Coefficient of Variation 25.1
|
PRIMARY outcome
Timeframe: From drug administration to 12 hours post-dosePopulation: 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%.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=55 Participants
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.
|
NovoLog
n=55 Participants
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.
|
|---|---|---|
|
Maximum Glucose Infusion Rate, Gmax
|
10.3 mg/kg/min
Geometric Coefficient of Variation 43.3
|
10.3 mg/kg/min
Geometric Coefficient of Variation 39.8
|
PRIMARY outcome
Timeframe: From drug administration to 12 hours post-dosePopulation: 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%.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=55 Participants
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.
|
NovoLog
n=55 Participants
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.
|
|---|---|---|
|
Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 12 Hours Post-dose, AUCG(0-12h)
|
1906.9 mg/kg
Geometric Coefficient of Variation 37.2
|
1985.7 mg/kg
Geometric Coefficient of Variation 39.8
|
SECONDARY outcome
Timeframe: 0 to infinity (extrapolated; concentrations measured through 12 hours post-dose)Population: 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.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=58 Participants
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.
|
NovoLog
n=58 Participants
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.
|
|---|---|---|
|
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to Infinity, AUCIA(0-∞)
|
7374.9 pg/mL * hr
Geometric Coefficient of Variation 25.5
|
7202.7 pg/mL * hr
Geometric Coefficient of Variation 24.4
|
SECONDARY outcome
Timeframe: 0 to 1 hour post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=58 Participants
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.
|
NovoLog
n=58 Participants
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.
|
|---|---|---|
|
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 1 Hour Post-dose, AUCIA(0-1h)
|
1438.9 pg/mL * hr
Geometric Coefficient of Variation 44.7
|
1496.6 pg/mL * hr
Geometric Coefficient of Variation 44.4
|
SECONDARY outcome
Timeframe: 0 to 2 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=58 Participants
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.
|
NovoLog
n=58 Participants
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.
|
|---|---|---|
|
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 2 Hours Post-dose, AUCIA(0-2h)
|
3886.9 pg/mL * hr
Geometric Coefficient of Variation 32.9
|
3757.0 pg/mL * hr
Geometric Coefficient of Variation 32.9
|
SECONDARY outcome
Timeframe: 0 to 4 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=58 Participants
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.
|
NovoLog
n=58 Participants
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.
|
|---|---|---|
|
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 4 Hours Post-dose, AUCIA(0-4h)
|
6478.7 pg/mL * hr
Geometric Coefficient of Variation 25.9
|
6204.1 pg/mL * hr
Geometric Coefficient of Variation 24.6
|
SECONDARY outcome
Timeframe: 4 to 12 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=58 Participants
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.
|
NovoLog
n=58 Participants
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.
|
|---|---|---|
|
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From 4 to 12 Hours Post-dose, AUCIA(4-12h)
|
567.2 pg/mL * hr
Geometric Coefficient of Variation 112.9
|
619.8 pg/mL * hr
Geometric Coefficient of Variation 119.9
|
SECONDARY outcome
Timeframe: Baseline (Time 0) to 12 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=58 Participants
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.
|
NovoLog
n=58 Participants
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.
|
|---|---|---|
|
Time of Maximum Insulin Aspart Serum Concentration, tIAmax
|
67.5 min
Interval 25.0 to 180.0
|
55.0 min
Interval 25.0 to 150.0
|
SECONDARY outcome
Timeframe: Baseline (Time 0) to 12 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=58 Participants
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.
|
NovoLog
n=58 Participants
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.
|
|---|---|---|
|
Apparent Clearance of Insulin Aspart, CL/F
|
74.2 L/hr
Geometric Coefficient of Variation 25.8
|
76.3 L/hr
Geometric Coefficient of Variation 23.5
|
SECONDARY outcome
Timeframe: Baseline (Time 0) to 12 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=58 Participants
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.
|
NovoLog
n=58 Participants
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.
|
|---|---|---|
|
Apparent Volume of Distribution of Insulin Aspart, Vz/F
|
96.8 L
Geometric Coefficient of Variation 47.3
|
104.1 L
Geometric Coefficient of Variation 48.4
|
SECONDARY outcome
Timeframe: Baseline (Time 0) to 12 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=58 Participants
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.
|
NovoLog
n=58 Participants
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.
|
|---|---|---|
|
Half-life of Insulin Aspart, t1/2
|
53.0 min
Interval 28.0 to 223.8
|
60.8 min
Interval 23.3 to 177.4
|
SECONDARY outcome
Timeframe: Baseline (Time 0) to 12 hours post-dosePopulation: 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.
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
Outcome measures
| Measure |
Insulin Aspart, I004
n=58 Participants
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.
|
NovoLog
n=58 Participants
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.
|
|---|---|---|
|
Maximum Serum Human Insulin Concentration, CHImax
|
559.4 pg/mL
Geometric Coefficient of Variation 53.0
|
563.8 pg/mL
Geometric Coefficient of Variation 62.6
|
SECONDARY outcome
Timeframe: 0 to 12 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=58 Participants
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.
|
NovoLog
n=58 Participants
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.
|
|---|---|---|
|
Area Under the Curve (AUC) of Human Insulin Serum Concentration From Time 0 to 12 Hours Post-dose, AUCHI(0-12h)
|
2662.7 pg/mL * hr
Geometric Coefficient of Variation 54.7
|
2634.8 pg/mL * hr
Geometric Coefficient of Variation 57.8
|
SECONDARY outcome
Timeframe: Baseline (Time 0) to 12 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=58 Participants
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.
|
NovoLog
n=58 Participants
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.
|
|---|---|---|
|
Time of Maximum Human Insulin Serum Concentration, tHImax
|
80.0 min
Interval 0.0 to 720.0
|
105.0 min
Interval 0.0 to 720.0
|
SECONDARY outcome
Timeframe: From drug administration to 12 hours post-dosePopulation: 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%.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=55 Participants
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.
|
NovoLog
n=55 Participants
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.
|
|---|---|---|
|
Area Under the Curve (AUC) for Glucose Infusion Rate Due to Insulin Aspart From Time 0 to 12 Hours Post-dose, AUCGA(0-12h)
|
1308.1 mg/kg
Geometric Coefficient of Variation 42.2
|
1364.8 mg/kg
Geometric Coefficient of Variation 39.3
|
SECONDARY outcome
Timeframe: From drug administration to 12 hours post-dosePopulation: 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%.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=55 Participants
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.
|
NovoLog
n=55 Participants
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.
|
|---|---|---|
|
Maximum Glucose Infusion Rate Due to Insulin Aspart, GAmax
|
8.1 mg/kg/min
Geometric Coefficient of Variation 47.0
|
8.3 mg/kg/min
Geometric Coefficient of Variation 41.4
|
SECONDARY outcome
Timeframe: From drug administration to 12 hours post-dosePopulation: 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%.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=55 Participants
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.
|
NovoLog
n=55 Participants
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.
|
|---|---|---|
|
Area Under the Curve (AUC) for Glucose Infusion Rate (GIR) From Time 0 to the Time of Last Measurable GIR, AUCG(0-last)
|
1906.9 mg/kg
Geometric Coefficient of Variation 37.2
|
1985.7 mg/kg
Geometric Coefficient of Variation 39.8
|
SECONDARY outcome
Timeframe: From drug administration to 1 hour post-dosePopulation: 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%.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=55 Participants
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.
|
NovoLog
n=55 Participants
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.
|
|---|---|---|
|
Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 1 Hour Post-dose, AUCG(0-1h)
|
115.8 mg/kg
Geometric Coefficient of Variation 79.5
|
123.6 mg/kg
Geometric Coefficient of Variation 72.0
|
SECONDARY outcome
Timeframe: From drug administration to 2 hours post-dosePopulation: 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%.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=55 Participants
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.
|
NovoLog
n=55 Participants
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.
|
|---|---|---|
|
Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 2 Hours Post-dose, AUCG(0-2h)
|
481.5 mg/kg
Geometric Coefficient of Variation 51.9
|
501.9 mg/kg
Geometric Coefficient of Variation 56.0
|
SECONDARY outcome
Timeframe: From drug administration to 4 hours post-dosePopulation: 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%.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=55 Participants
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.
|
NovoLog
n=55 Participants
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.
|
|---|---|---|
|
Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 4 Hours Post-dose, AUCG(0-4h)
|
1268.9 mg/kg
Geometric Coefficient of Variation 43.3
|
1305.0 mg/kg
Geometric Coefficient of Variation 44.7
|
SECONDARY outcome
Timeframe: From 4 hours post-dose to 12 hours post-dosePopulation: 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%.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=55 Participants
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.
|
NovoLog
n=55 Participants
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.
|
|---|---|---|
|
Area Under the Curve (AUC) for Glucose Infusion Rate From Time 4 to 12 Hours Post-dose, AUCG(4-12h)
|
555.9 mg/kg
Geometric Coefficient of Variation 64.1
|
589.3 mg/kg
Geometric Coefficient of Variation 68.2
|
SECONDARY outcome
Timeframe: From drug administration to 12 hours post-dosePopulation: 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%.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=55 Participants
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.
|
NovoLog
n=55 Participants
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.
|
|---|---|---|
|
Last Measurable Glucose Infusion Rate, Glast
|
0.1 mg/kg/min
Geometric Coefficient of Variation 3827.7
|
0.0 mg/kg/min
Geometric Coefficient of Variation 2252.0
|
SECONDARY outcome
Timeframe: From drug administration to 12 hours post-dosePopulation: 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%.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=55 Participants
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.
|
NovoLog
n=55 Participants
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.
|
|---|---|---|
|
Time of Maximum Glucose Infusion Rate, tGmax
|
160.0 min
Interval 47.0 to 286.0
|
136.0 min
Interval 43.0 to 265.0
|
SECONDARY outcome
Timeframe: From drug administration to 12 hours post-dosePopulation: 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%.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=55 Participants
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.
|
NovoLog
n=55 Participants
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.
|
|---|---|---|
|
Time of Glucose Infusion Start, tGonset
|
22.0 min
Interval 1.0 to 40.0
|
20.0 min
Interval 1.0 to 50.0
|
SECONDARY outcome
Timeframe: From drug administration to 12 hours post-dosePopulation: 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%.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=55 Participants
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.
|
NovoLog
n=55 Participants
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.
|
|---|---|---|
|
Time of Last Measurable Glucose Infusion Rate, tGlast
|
720.0 min
Interval 334.0 to 720.0
|
712.0 min
Interval 367.0 to 720.0
|
SECONDARY outcome
Timeframe: From drug administration to 12 hours post-dosePopulation: 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%.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=55 Participants
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.
|
NovoLog
n=55 Participants
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.
|
|---|---|---|
|
Time to Half of Maximum Glucose Infusion Rate (Gmax) Before Gmax Is Reached, tG50%Early
|
76.7 min
Interval 31.4 to 254.7
|
71.5 min
Interval 25.2 to 221.4
|
SECONDARY outcome
Timeframe: From drug administration to 12 hours post-dosePopulation: 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%.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=55 Participants
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.
|
NovoLog
n=55 Participants
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.
|
|---|---|---|
|
Time to Half of Maximum Glucose Infusion Rate (Gmax) After Gmax Is Reached, tG50%Late
|
211.9 min
Interval 70.3 to 364.8
|
216.2 min
Interval 66.1 to 361.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (15 minutes pre-dose), 5 minutes, 60 minutes, 180 minutes, and 720 minutes post-dosePopulation: Treated Population: all subjects who have received any amount of the study drug treatment.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=65 Participants
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.
|
NovoLog
n=66 Participants
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.
|
|---|---|---|
|
Systolic Blood Pressure (SBP)
Baseline
|
109 mmHg
Standard Deviation 9
|
109 mmHg
Standard Deviation 10
|
|
Systolic Blood Pressure (SBP)
5 minutes post-dose
|
111 mmHg
Standard Deviation 9
|
109 mmHg
Standard Deviation 11
|
|
Systolic Blood Pressure (SBP)
60 minutes post-dose
|
109 mmHg
Standard Deviation 9
|
108 mmHg
Standard Deviation 10
|
|
Systolic Blood Pressure (SBP)
180 minutes post-dose
|
107 mmHg
Standard Deviation 9
|
107 mmHg
Standard Deviation 9
|
|
Systolic Blood Pressure (SBP)
720 minutes post-dose
|
116 mmHg
Standard Deviation 11
|
113 mmHg
Standard Deviation 11
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (15 minutes pre-dose), 5 minutes, 60 minutes, 180 minutes, and 720 minutes post-dosePopulation: Treated Population: all subjects who have received any amount of the study drug treatment.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=65 Participants
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.
|
NovoLog
n=66 Participants
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.
|
|---|---|---|
|
Diastolic Blood Pressure (DBP)
180 minutes post-dose
|
67 mmHg
Standard Deviation 6
|
67 mmHg
Standard Deviation 5
|
|
Diastolic Blood Pressure (DBP)
720 minutes post-dose
|
71 mmHg
Standard Deviation 6
|
70 mmHg
Standard Deviation 7
|
|
Diastolic Blood Pressure (DBP)
Baseline
|
70 mmHg
Standard Deviation 6
|
70 mmHg
Standard Deviation 6
|
|
Diastolic Blood Pressure (DBP)
5 minutes post-dose
|
70 mmHg
Standard Deviation 6
|
70 mmHg
Standard Deviation 7
|
|
Diastolic Blood Pressure (DBP)
60 minutes post-dose
|
68 mmHg
Standard Deviation 6
|
68 mmHg
Standard Deviation 6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (15 minutes pre-dose), 5 minutes, 60 minutes, 180 minutes, and 720 minutes post-dosePopulation: Treated Population: all subjects who have received any amount of the study drug treatment.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=65 Participants
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.
|
NovoLog
n=66 Participants
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.
|
|---|---|---|
|
Heart Rate (HR)
Baseline
|
62 bpm
Standard Deviation 7
|
64 bpm
Standard Deviation 9
|
|
Heart Rate (HR)
5 minutes post-dose
|
63 bpm
Standard Deviation 9
|
62 bpm
Standard Deviation 8
|
|
Heart Rate (HR)
60 minutes post-dose
|
64 bpm
Standard Deviation 9
|
66 bpm
Standard Deviation 9
|
|
Heart Rate (HR)
180 minutes post-dose
|
67 bpm
Standard Deviation 10
|
66 bpm
Standard Deviation 11
|
|
Heart Rate (HR)
720 minutes post-dose
|
65 bpm
Standard Deviation 9
|
66 bpm
Standard Deviation 9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (15 minutes pre-dose), 5 minutes, 60 minutes, 180 minutes, and 720 minutes post-dosePopulation: Treated Population: all subjects who have received any amount of the study drug treatment.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=65 Participants
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.
|
NovoLog
n=66 Participants
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.
|
|---|---|---|
|
QT Interval
Baseline
|
408 ms
Standard Deviation 21
|
409 ms
Standard Deviation 23
|
|
QT Interval
5 minutes post-dose
|
406 ms
Standard Deviation 20
|
407 ms
Standard Deviation 22
|
|
QT Interval
60 minutes post-dose
|
403 ms
Standard Deviation 23
|
399 ms
Standard Deviation 23
|
|
QT Interval
180 minutes post-dose
|
396 ms
Standard Deviation 22
|
397 ms
Standard Deviation 22
|
|
QT Interval
720 minutes post-dose
|
402 ms
Standard Deviation 21
|
401 ms
Standard Deviation 23
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (15 minutes pre-dose), 5 minutes, 60 minutes, 180 minutes, and 720 minutes post-dosePopulation: Treated Population: all subjects who have received any amount of the study drug treatment.
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.
Outcome measures
| Measure |
Insulin Aspart, I004
n=65 Participants
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.
|
NovoLog
n=66 Participants
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.
|
|---|---|---|
|
Corrected QT (QTc-F) Interval
Baseline
|
409 ms
Standard Deviation 17
|
410 ms
Standard Deviation 18
|
|
Corrected QT (QTc-F) Interval
5 minutes post-dose
|
411 ms
Standard Deviation 17
|
409 ms
Standard Deviation 20
|
|
Corrected QT (QTc-F) Interval
60 minutes post-dose
|
408 ms
Standard Deviation 20
|
406 ms
Standard Deviation 20
|
|
Corrected QT (QTc-F) Interval
180 minutes post-dose
|
407 ms
Standard Deviation 19
|
407 ms
Standard Deviation 19
|
|
Corrected QT (QTc-F) Interval
720 minutes post-dose
|
412 ms
Standard Deviation 19
|
410 ms
Standard Deviation 19
|
Adverse Events
Insulin Aspart, I004
NovoLog
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Insulin Aspart, I004
n=65 participants at risk
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.
|
NovoLog
n=66 participants at risk
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.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.2%
4/65 • Number of events 5 • From signing of consent until follow-up (approximately 10 weeks)
|
1.5%
1/66 • Number of events 1 • From signing of consent until follow-up (approximately 10 weeks)
|
|
Nervous system disorders
Headache
|
6.2%
4/65 • Number of events 4 • From signing of consent until follow-up (approximately 10 weeks)
|
12.1%
8/66 • Number of events 8 • From signing of consent until follow-up (approximately 10 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/65 • From signing of consent until follow-up (approximately 10 weeks)
|
3.0%
2/66 • Number of events 2 • From signing of consent until follow-up (approximately 10 weeks)
|
Additional Information
Amphastar Pharmaceuticals, Inc.
Amphastar Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place