Healthy
Conditions
Keywords
insulin, recombinant human hyaluronidase, Healthy volunteers
Brief summary
This is a single-center, Phase 1, randomized, double-blind, 6-way crossover study to determine insulin pharmacokinetics, insulin glucodynamics, safety, and tolerability of subcutaneously administered dose(s) of insulin lispro + recombinant human hyaluronidase PH20 (rHuPH20), insulin lispro alone, insulin glulisine + rHuPH20, insulin glulisine alone, insulin aspart + rHuPH20, and insulin aspart alone.
Interventions
DRUGInsulin lispro
DRUGInsulin glulisine
DRUGInsulin aspart
Sponsors
Halozyme Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy participants between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities). * Body mass index (BMI) between 18-27 kilograms per meter squared (kg/m\^2), inclusive. * Total body weight \>65 kilograms (kg) (143 pounds \[lb\]) for men and \>46 kg (101 lb) for women. * Decision making capacity and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including adequate venous access. * Vital signs (blood pressure \[BP\], pulse rate, body temperature) within normal range or, if out of range, assessed by the Principal Investigator as not clinically significant. * Fasting blood glucose level \<100 milligrams per deciliter (mg/dL) at screening. * A negative serum pregnancy test (if female of childbearing potential). * Female participants of childbearing potential must agree to practice effective birth control or abstinence currently and agree to continue to do so for the duration of their time on study. * Signed, written institutional review board (IRB)-approved informed consent.
Exclusion criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, oncologic, or neurologic (to include history of seizures) disease; hypoglycemic episodes; intercurrent illness (such as influenza); or allergic disease (including severe drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Clinical significance to be determined by the Principal Investigator. * As judged by the investigator, clinically significant findings in routine laboratory data. (Anemia with hematocrit less than 33% at screening is specifically exclusionary.) * Known history of diabetes mellitus (type 1 or type 2) or gestational diabetes. * Known allergy to hyaluronidase or any other ingredient in the study drug. * Positive human immunodeficiency virus (HIV) 1, hepatitis B, or hepatitis C antibody test. * History or evidence of alcohol or drug abuse. * History or evidence of use of any tobacco- or nicotine-containing product within 6 months prior to screening and a screening qualitative urine nicotine test. * Use of drugs that may interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action or glucose utilization. * Blood donation or high volume phlebotomy, for example, \>100 milliliters (mL), within 56 days before dosing. * Participation in a study of any investigational drug or device 30 days before enrollment in this study. * The participant is unfit for the study in the opinion of the investigator. * Women who are pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60) | Predose up to 60 minutes postdose | Area under the concentration (AUC)-time curve was derived as the area under the serum insulin concentration profile from 0 to 60 minutes. Blood samples were taken 30, 20, and 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and at 20, 25, 30, 45, and 60 mins after each injection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Serum Insulin Concentration (Tmax) | Predose up to 480 minutes postdose | Tmax was determined as the timepoint where the maximum of all valid concentration measurements for each measurement series was observed. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection. |
| Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max]) | Predose up to 480 minutes postdose | Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection. |
| Time to Maximum Glucose Infusion Rate (tGIR[Max]) | Predose up to 480 minutes postdose | Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection. |
| Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | Predose up to 120 minutes postdose | Percentage of total area under the concentration (AUC)-time curve at 15, 30, 60, 120 minutes after injection was measured. Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); and at 90 and 120 mins after each injection. |
| Time to Percentage of Total Insulin Exposure | Predose up to 480 minutes postdose | Time to 10% and 50% of total insulin exposure was measured. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C). Each intervention was separated by a 3- to 14-day washout.
Intervention A: Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20) and a single, SC injection of 95 U/mL Lispro alone 3 to 14 days apart.
Intervention B: Participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Glulis alone 3 to 14 days apart.
Intervention C: Participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Aspart alone 3 to 14 days apart. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 33.7 years STANDARD_DEVIATION 8.96 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 14 | 2 / 14 | 2 / 14 | 3 / 14 | 2 / 14 | 2 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 |
Outcome results
Primary
Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60)
Area under the concentration (AUC)-time curve was derived as the area under the serum insulin concentration profile from 0 to 60 minutes. Blood samples were taken 30, 20, and 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and at 20, 25, 30, 45, and 60 mins after each injection.
Time frame: Predose up to 60 minutes postdose
Population: Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable AUC0-60 data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glulisine Alone | Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60) | 11667.14 minutes*nanomolars (min*nM) | Standard Deviation 4085 |
| Glulisine + rHuPH20 | Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60) | 23807.14 minutes*nanomolars (min*nM) | Standard Deviation 6657.73 |
| Lispro Alone | Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60) | 10687.14 minutes*nanomolars (min*nM) | Standard Deviation 5532.49 |
| Lispro + rHuPH20 | Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60) | 27850.00 minutes*nanomolars (min*nM) | Standard Deviation 9684.94 |
| Aspart Alone | Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60) | 8065.00 minutes*nanomolars (min*nM) | Standard Deviation 3138.37 |
| Aspart + rHuPH20 | Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60) | 20778.57 minutes*nanomolars (min*nM) | Standard Deviation 6383.05 |
p-value: <0.000190% CI: [1.7, 2.55]Mixed Models Analysis
p-value: <0.000190% CI: [3.88, 7.12]Mixed Models Analysis
p-value: <0.000190% CI: [3.05, 5.6]Mixed Models Analysis
Secondary
Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t)
Percentage of total area under the concentration (AUC)-time curve at 15, 30, 60, 120 minutes after injection was measured. Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); and at 90 and 120 mins after each injection.
Time frame: Predose up to 120 minutes postdose
Population: Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20) , Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable AUC0-t data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Glulisine Alone | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-15 | 2.02 percentage of total AUC | Standard Deviation 1.1 |
| Glulisine Alone | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-30 | 7.09 percentage of total AUC | Standard Deviation 3.4 |
| Glulisine Alone | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-60 | 20.68 percentage of total AUC | Standard Deviation 8.07 |
| Glulisine Alone | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-120 | 50.35 percentage of total AUC | Standard Deviation 12.69 |
| Glulisine + rHuPH20 | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-60 | 39.45 percentage of total AUC | Standard Deviation 10.64 |
| Glulisine + rHuPH20 | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-30 | 15.82 percentage of total AUC | Standard Deviation 5.56 |
| Glulisine + rHuPH20 | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-15 | 5.29 percentage of total AUC | Standard Deviation 2.06 |
| Glulisine + rHuPH20 | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-120 | 71.70 percentage of total AUC | Standard Deviation 11.07 |
| Lispro Alone | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-120 | 50.14 percentage of total AUC | Standard Deviation 12.1 |
| Lispro Alone | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-60 | 18.72 percentage of total AUC | Standard Deviation 7.74 |
| Lispro Alone | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-30 | 3.88 percentage of total AUC | Standard Deviation 2.71 |
| Lispro Alone | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-15 | 0.68 percentage of total AUC | Standard Deviation 0.65 |
| Lispro + rHuPH20 | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-15 | 2.38 percentage of total AUC | Standard Deviation 1.24 |
| Lispro + rHuPH20 | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-120 | 77.00 percentage of total AUC | Standard Deviation 7.54 |
| Lispro + rHuPH20 | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-30 | 13.81 percentage of total AUC | Standard Deviation 5.37 |
| Lispro + rHuPH20 | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-60 | 42.88 percentage of total AUC | Standard Deviation 8.89 |
| Aspart Alone | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-60 | 16.85 percentage of total AUC | Standard Deviation 6.54 |
| Aspart Alone | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-120 | 47.97 percentage of total AUC | Standard Deviation 12.32 |
| Aspart Alone | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-30 | 3.54 percentage of total AUC | Standard Deviation 1.9 |
| Aspart Alone | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-15 | 0.56 percentage of total AUC | Standard Deviation 0.3 |
| Aspart + rHuPH20 | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-30 | 13.66 percentage of total AUC | Standard Deviation 7.05 |
| Aspart + rHuPH20 | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-60 | 41.51 percentage of total AUC | Standard Deviation 12.06 |
| Aspart + rHuPH20 | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-120 | 77.37 percentage of total AUC | Standard Deviation 8.8 |
| Aspart + rHuPH20 | Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) | AUC0-15 | 2.92 percentage of total AUC | Standard Deviation 2.28 |
Secondary
Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])
Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.
Time frame: Predose up to 480 minutes postdose
Population: Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable t(50%max) data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Glulisine Alone | Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max]) | early t(50%max) | 21.06 minutes | Standard Deviation 9.6 |
| Glulisine Alone | Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max]) | late t(50%max) | 195.43 minutes | Standard Deviation 48.63 |
| Glulisine + rHuPH20 | Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max]) | early t(50%max) | 10.16 minutes | Standard Deviation 4.9 |
| Glulisine + rHuPH20 | Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max]) | late t(50%max) | 118.92 minutes | Standard Deviation 33.57 |
| Lispro Alone | Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max]) | early t(50%max) | 30.69 minutes | Standard Deviation 12.58 |
| Lispro Alone | Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max]) | late t(50%max) | 176.79 minutes | Standard Deviation 30 |
| Lispro + rHuPH20 | Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max]) | early t(50%max) | 18.96 minutes | Standard Deviation 5.27 |
| Lispro + rHuPH20 | Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max]) | late t(50%max) | 89.59 minutes | Standard Deviation 21.38 |
| Aspart Alone | Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max]) | early t(50%max) | 31.93 minutes | Standard Deviation 8.15 |
| Aspart Alone | Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max]) | late t(50%max) | 193.50 minutes | Standard Deviation 45.94 |
| Aspart + rHuPH20 | Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max]) | early t(50%max) | 17.98 minutes | Standard Deviation 5.22 |
| Aspart + rHuPH20 | Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max]) | late t(50%max) | 102.82 minutes | Standard Deviation 24.74 |
Secondary
Time to Maximum Glucose Infusion Rate (tGIR[Max])
Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.
Time frame: Predose up to 480 minutes postdose
Population: Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable tGIR(max) data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glulisine Alone | Time to Maximum Glucose Infusion Rate (tGIR[Max]) | 141.93 minutes | Standard Deviation 71.18 |
| Glulisine + rHuPH20 | Time to Maximum Glucose Infusion Rate (tGIR[Max]) | 113.36 minutes | Standard Deviation 69.85 |
| Lispro Alone | Time to Maximum Glucose Infusion Rate (tGIR[Max]) | 160.14 minutes | Standard Deviation 71.36 |
| Lispro + rHuPH20 | Time to Maximum Glucose Infusion Rate (tGIR[Max]) | 103.57 minutes | Standard Deviation 58.83 |
| Aspart Alone | Time to Maximum Glucose Infusion Rate (tGIR[Max]) | 158.79 minutes | Standard Deviation 52.34 |
| Aspart + rHuPH20 | Time to Maximum Glucose Infusion Rate (tGIR[Max]) | 96.93 minutes | Standard Deviation 56.65 |
Secondary
Time to Maximum Serum Insulin Concentration (Tmax)
Tmax was determined as the timepoint where the maximum of all valid concentration measurements for each measurement series was observed. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.
Time frame: Predose up to 480 minutes postdose
Population: Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable tmax data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glulisine Alone | Time to Maximum Serum Insulin Concentration (Tmax) | 80.36 minutes | Standard Deviation 25.38 |
| Glulisine + rHuPH20 | Time to Maximum Serum Insulin Concentration (Tmax) | 41.43 minutes | Standard Deviation 12.47 |
| Lispro Alone | Time to Maximum Serum Insulin Concentration (Tmax) | 67.50 minutes | Standard Deviation 32.09 |
| Lispro + rHuPH20 | Time to Maximum Serum Insulin Concentration (Tmax) | 41.07 minutes | Standard Deviation 17.56 |
| Aspart Alone | Time to Maximum Serum Insulin Concentration (Tmax) | 85.71 minutes | Standard Deviation 35.99 |
| Aspart + rHuPH20 | Time to Maximum Serum Insulin Concentration (Tmax) | 43.57 minutes | Standard Deviation 12.92 |
p-value: <0.000190% CI: [-53.31, -24.55]ANOVA
p-value: 0.003290% CI: [-40.81, -12.05]ANOVA
p-value: <0.000190% CI: [-56.53, -27.76]ANOVA
Secondary
Time to Percentage of Total Insulin Exposure
Time to 10% and 50% of total insulin exposure was measured. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.
Time frame: Predose up to 480 minutes postdose
Population: Participants who received at least one dose of Lispro alone, Lispro + rHuPH20, Glulisine alone, Glulisine + recombinant human hyaluronidase PH20 (rHuPH20), Aspart alone, or Aspart + rHuPH20 with evaluable total insulin exposure data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Glulisine Alone | Time to Percentage of Total Insulin Exposure | Time to 10% of total insulin exposure | 39.59 minutes | Standard Deviation 9.95 |
| Glulisine Alone | Time to Percentage of Total Insulin Exposure | Time to 50% of total insulin exposure | 123.65 minutes | Standard Deviation 27.48 |
| Glulisine + rHuPH20 | Time to Percentage of Total Insulin Exposure | Time to 10% of total insulin exposure | 23.39 minutes | Standard Deviation 6.38 |
| Glulisine + rHuPH20 | Time to Percentage of Total Insulin Exposure | Time to 50% of total insulin exposure | 78.64 minutes | Standard Deviation 18.82 |
| Lispro Alone | Time to Percentage of Total Insulin Exposure | Time to 10% of total insulin exposure | 46.56 minutes | Standard Deviation 11.89 |
| Lispro Alone | Time to Percentage of Total Insulin Exposure | Time to 50% of total insulin exposure | 123.39 minutes | Standard Deviation 27.87 |
| Lispro + rHuPH20 | Time to Percentage of Total Insulin Exposure | Time to 10% of total insulin exposure | 26.35 minutes | Standard Deviation 5.6 |
| Lispro + rHuPH20 | Time to Percentage of Total Insulin Exposure | Time to 50% of total insulin exposure | 70.97 minutes | Standard Deviation 12.61 |
| Aspart Alone | Time to Percentage of Total Insulin Exposure | Time to 10% of total insulin exposure | 48.42 minutes | Standard Deviation 9.96 |
| Aspart Alone | Time to Percentage of Total Insulin Exposure | Time to 50% of total insulin exposure | 130.86 minutes | Standard Deviation 30.04 |
| Aspart + rHuPH20 | Time to Percentage of Total Insulin Exposure | Time to 10% of total insulin exposure | 26.99 minutes | Standard Deviation 6.57 |
| Aspart + rHuPH20 | Time to Percentage of Total Insulin Exposure | Time to 50% of total insulin exposure | 72.53 minutes | Standard Deviation 14.86 |