A Phase 2/3 interventional study of I004 and NovoLog in Pharmacokinetics and Pharmacodynamics, sponsored by Amphastar Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Amphastar Pharmaceuticals, Inc. · Phase 2/3, Interventional, and Treatment
This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamics (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
Amphastar Pharmaceuticals, Inc. is the lead sponsor of 21 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who were dosed with I004
Drug: I004
Participants who were dosed with NovoLog
Drug: 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.
Also known as: Insulin Aspart, a rapid-acting human insulin analogue
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.
Also known as: Insulin Aspart, a rapid-acting human insulin analogue
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.
Time frame: Baseline (Time 0) to 12 hours post-dose
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.
Time frame: 0 to 12 hours post-dose
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.
Time frame: From drug administration to 12 hours post-dose
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.
Time frame: From drug administration to 12 hours post-dose
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.
Time frame: 0 to infinity (extrapolated; concentrations measured through 12 hours post-dose)
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.
Time frame: 0 to 1 hour post-dose
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.
Time frame: 0 to 2 hours post-dose
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.
Time frame: 0 to 4 hours post-dose
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.
Time frame: 4 to 12 hours post-dose
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.
Time frame: Baseline (Time 0) to 12 hours post-dose
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.
Time frame: Baseline (Time 0) to 12 hours post-dose
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.
Time frame: Baseline (Time 0) to 12 hours post-dose
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.
Time frame: Baseline (Time 0) to 12 hours post-dose
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
Time frame: Baseline (Time 0) to 12 hours post-dose
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.
Time frame: 0 to 12 hours post-dose
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.
Time frame: Baseline (Time 0) to 12 hours post-dose
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.
Time frame: From drug administration to 12 hours post-dose
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.
Time frame: From drug administration to 12 hours post-dose
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.
Time frame: From drug administration to 12 hours post-dose
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.
Time frame: From drug administration to 1 hour post-dose
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.
Time frame: From drug administration to 2 hours post-dose
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.
Time frame: From drug administration to 4 hours post-dose
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.
Time frame: From 4 hours post-dose to 12 hours post-dose
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.
Time frame: From drug administration to 12 hours post-dose
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.
Time frame: From drug administration to 12 hours post-dose
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.
Time frame: From drug administration to 12 hours post-dose
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.
Time frame: From drug administration to 12 hours post-dose
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.
Time frame: From drug administration to 12 hours post-dose
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.
Time frame: From drug administration to 12 hours post-dose
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.
Time frame: Baseline (15 minutes pre-dose), 5 minutes, 60 minutes, 180 minutes, and 720 minutes post-dose
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.
Time frame: Baseline (15 minutes pre-dose), 5 minutes, 60 minutes, 180 minutes, and 720 minutes post-dose
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.
Time frame: Baseline (15 minutes pre-dose), 5 minutes, 60 minutes, 180 minutes, and 720 minutes post-dose
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.
Time frame: Baseline (15 minutes pre-dose), 5 minutes, 60 minutes, 180 minutes, and 720 minutes post-dose
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.
Time frame: Baseline (15 minutes pre-dose), 5 minutes, 60 minutes, 180 minutes, and 720 minutes post-dose
| Milestone | Treatment T - Treatment R | Treatment R - Treatment T |
|---|---|---|
| Started | 35 | 34 |
| Completed | 35 | 34 |
| Not completed | 0 | 0 |
| Milestone | Treatment T - Treatment R | Treatment R - Treatment T |
|---|---|---|
| Started | 35 | 34 |
| Completed | 32 | 30 |
| Not completed | 3 | 4 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Subject unreachable | 0 | 1 |
| Milestone | Treatment T - Treatment R | Treatment R - Treatment T |
|---|---|---|
| Started | 32 | 30 |
| Completed | 32 | 28 |
| Not completed | 0 | 2 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| pg/mL | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Maximum Serum Insulin Aspart Concentration, CIAmax | 2961.8 ± 32.9 | 2827.4 ± 31.4 |
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.
| pg/mL * hr | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 12 Hours Post-dose, AUCIA(0-12h) | 7215.0 ± 26.0 | 6976.9 ± 25.1 |
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.
| mg/kg/min | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Maximum Glucose Infusion Rate, Gmax | 10.3 ± 43.3 | 10.3 ± 39.8 |
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.
| mg/kg | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 12 Hours Post-dose, AUCG(0-12h) | 1906.9 ± 37.2 | 1985.7 ± 39.8 |
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.
| pg/mL * hr | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to Infinity, AUCIA(0-∞) | 7374.9 ± 25.5 | 7202.7 ± 24.4 |
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.
| pg/mL * hr | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 1 Hour Post-dose, AUCIA(0-1h) | 1438.9 ± 44.7 | 1496.6 ± 44.4 |
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.
| pg/mL * hr | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 2 Hours Post-dose, AUCIA(0-2h) | 3886.9 ± 32.9 | 3757.0 ± 32.9 |
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.
| pg/mL * hr | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to 4 Hours Post-dose, AUCIA(0-4h) | 6478.7 ± 25.9 | 6204.1 ± 24.6 |
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.
| pg/mL * hr | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From 4 to 12 Hours Post-dose, AUCIA(4-12h) | 567.2 ± 112.9 | 619.8 ± 119.9 |
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.
| min | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Time of Maximum Insulin Aspart Serum Concentration, tIAmax | 67.5 (25.0 to 180.0) | 55.0 (25.0 to 150.0) |
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.
| L/hr | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Apparent Clearance of Insulin Aspart, CL/F | 74.2 ± 25.8 | 76.3 ± 23.5 |
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.
| L | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Apparent Volume of Distribution of Insulin Aspart, Vz/F | 96.8 ± 47.3 | 104.1 ± 48.4 |
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.
| min | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Half-life of Insulin Aspart, t1/2 | 53.0 (28.0 to 223.8) | 60.8 (23.3 to 177.4) |
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
| pg/mL | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Maximum Serum Human Insulin Concentration, CHImax | 559.4 ± 53.0 | 563.8 ± 62.6 |
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.
| pg/mL * hr | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Area Under the Curve (AUC) of Human Insulin Serum Concentration From Time 0 to 12 Hours Post-dose, AUCHI(0-12h) | 2662.7 ± 54.7 | 2634.8 ± 57.8 |
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.
| min | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Time of Maximum Human Insulin Serum Concentration, tHImax | 80.0 (0.0 to 720.0) | 105.0 (0.0 to 720.0) |
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.
| mg/kg | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| 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 ± 42.2 | 1364.8 ± 39.3 |
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.
| mg/kg/min | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Maximum Glucose Infusion Rate Due to Insulin Aspart, GAmax | 8.1 ± 47.0 | 8.3 ± 41.4 |
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.
| mg/kg | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| 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 ± 37.2 | 1985.7 ± 39.8 |
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.
| mg/kg | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 1 Hour Post-dose, AUCG(0-1h) | 115.8 ± 79.5 | 123.6 ± 72.0 |
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.
| mg/kg | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 2 Hours Post-dose, AUCG(0-2h) | 481.5 ± 51.9 | 501.9 ± 56.0 |
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.
| mg/kg | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Area Under the Curve (AUC) for Glucose Infusion Rate From Time 0 to 4 Hours Post-dose, AUCG(0-4h) | 1268.9 ± 43.3 | 1305.0 ± 44.7 |
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.
| mg/kg | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Area Under the Curve (AUC) for Glucose Infusion Rate From Time 4 to 12 Hours Post-dose, AUCG(4-12h) | 555.9 ± 64.1 | 589.3 ± 68.2 |
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.
| mg/kg/min | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Last Measurable Glucose Infusion Rate, Glast | 0.1 ± 3827.7 | 0.0 ± 2252.0 |
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.
| min | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Time of Maximum Glucose Infusion Rate, tGmax | 160.0 (47.0 to 286.0) | 136.0 (43.0 to 265.0) |
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.
| min | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Time of Glucose Infusion Start, tGonset | 22.0 (1.0 to 40.0) | 20.0 (1.0 to 50.0) |
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.
| min | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Time of Last Measurable Glucose Infusion Rate, tGlast | 720.0 (334.0 to 720.0) | 712.0 (367.0 to 720.0) |
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.
| min | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Time to Half of Maximum Glucose Infusion Rate (Gmax) Before Gmax Is Reached, tG50%Early | 76.7 (31.4 to 254.7) | 71.5 (25.2 to 221.4) |
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.
| min | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Time to Half of Maximum Glucose Infusion Rate (Gmax) After Gmax Is Reached, tG50%Late | 211.9 (70.3 to 364.8) | 216.2 (66.1 to 361.1) |
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.
| mmHg | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Baseline | 109 ± 9 | 109 ± 10 |
| 5 minutes post-dose | 111 ± 9 | 109 ± 11 |
| 60 minutes post-dose | 109 ± 9 | 108 ± 10 |
| 180 minutes post-dose | 107 ± 9 | 107 ± 9 |
| 720 minutes post-dose | 116 ± 11 | 113 ± 11 |
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.
| mmHg | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Baseline | 70 ± 6 | 70 ± 6 |
| 5 minutes post-dose | 70 ± 6 | 70 ± 7 |
| 60 minutes post-dose | 68 ± 6 | 68 ± 6 |
| 180 minutes post-dose | 67 ± 6 | 67 ± 5 |
| 720 minutes post-dose | 71 ± 6 | 70 ± 7 |
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.
| bpm | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Baseline | 62 ± 7 | 64 ± 9 |
| 5 minutes post-dose | 63 ± 9 | 62 ± 8 |
| 60 minutes post-dose | 64 ± 9 | 66 ± 9 |
| 180 minutes post-dose | 67 ± 10 | 66 ± 11 |
| 720 minutes post-dose | 65 ± 9 | 66 ± 9 |
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.
| ms | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Baseline | 408 ± 21 | 409 ± 23 |
| 5 minutes post-dose | 406 ± 20 | 407 ± 22 |
| 60 minutes post-dose | 403 ± 23 | 399 ± 23 |
| 180 minutes post-dose | 396 ± 22 | 397 ± 22 |
| 720 minutes post-dose | 402 ± 21 | 401 ± 23 |
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.
| ms | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| Baseline | 409 ± 17 | 410 ± 18 |
| 5 minutes post-dose | 411 ± 17 | 409 ± 20 |
| 60 minutes post-dose | 408 ± 20 | 406 ± 20 |
| 180 minutes post-dose | 407 ± 19 | 407 ± 19 |
| 720 minutes post-dose | 412 ± 19 | 410 ± 19 |
Collected over From signing of consent until follow-up (approximately 10 weeks). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Insulin Aspart, I004 | 0/65 (0%) | 0/65 (0%) | 7/65 (10.8%) |
| NovoLog | 0/66 (0%) | 0/66 (0%) | 10/66 (15.2%) |
| Event | Insulin Aspart, I004 | NovoLog |
|---|---|---|
| HeadacheNervous system disorders | 4/65 | 8/66 |
| HypoglycaemiaMetabolism and nutrition disorders | 4/65 | 1/66 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/65 | 2/66 |
| Age, Continuous(years) | Intent To Treat Population |
|---|---|
| Mean | 39.6 ± 11.7 |
| Sex: Female, Male(Participants) | Intent To Treat Population |
|---|---|
| Female | 26 |
| Male | 43 |
| Race/Ethnicity, Customized(Participants) | Intent To Treat Population |
|---|---|
| White | 43 |
| Black or African-American | 13 |
| Asian | 9 |
| Native Hawaiian or Other Pacific Islander | 1 |
| American Indian or Alaska Native | 0 |
| Other | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Access to patient level data and supporting clinical documents may be requested by qualified researchers. Requests will be reviewed on the basis of scientific merit. Patient data will be de-identified to protect the privacy of trial patients in line with applicable laws and regulations.
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Studies of the drug tested here: Insulin Aspart
Amphastar Pharmaceuticals, Inc.