Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lispro+PH20, Lispro, Glulis+PH20, Glulis, Aspart+PH20, Aspart | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant human hyaluronidase PH20 (rHuPH20) | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Predose up to 60 minutes postdose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marcus Hompesch, M.D. | Profil Institute for Clinical Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institute for Clinical Research, Inc. | Chula Vista | California | 91911 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23043164 | Derived | Morrow L, Muchmore DB, Hompesch M, Ludington EA, Vaughn DE. Comparative pharmacokinetics and insulin action for three rapid-acting insulin analogs injected subcutaneously with and without hyaluronidase. Diabetes Care. 2013 Feb;36(2):273-5. doi: 10.2337/dc12-0808. Epub 2012 Oct 5. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lispro+PH20, Lispro, Glulis, Glulis+PH20, Aspart, Aspart+PH20 | 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). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone. After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 µg/mL PH20. After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Intervention 1 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Insulin lispro | Drug |
|
|
| Insulin glulisine | Drug |
|
|
| Insulin aspart | Drug |
|
|
| Predose up to 480 minutes postdose |
| 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. | Predose up to 480 minutes postdose |
| 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. | Predose up to 480 minutes postdose |
| 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. | Predose up to 120 minutes postdose |
| 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. | Predose up to 480 minutes postdose |
| FG001 | Glulis+PH20, Glulis, Lispro+PH20, Lispro, Aspart+PH20, Aspart | Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Glulisine (Glulis) + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis alone. After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone. After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone. |
| FG002 | Lispro, Lispro+PH20, Aspart, Aspart+PH20, Glulis, Glulis+PH20 | Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20. After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 µg/mL PH20. |
| FG003 | Glulis, Glulis+PH20, Aspart+PH20, Aspart, Lispro+PH20, Lispro | Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone. After a 3- to 14-day washout, participants received a single, subcutaneous (SC) injection of 95 U/mL Lispro + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone. |
| FG004 | Aspart+PH20, Aspart, Glulis+PH20, Glulis, Lispro, Lispro+PH20 | Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone. After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20. Then, 3 to 14 days later, participants received and a single, SC injection of 95 U/mL Glulisine alone. After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20. |
| FG005 | Aspart, Aspart+PH20, Lispro, Lispro+PH20, Glulis+PH20, Glulis | Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20. After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis alone. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Washout 1 (3 to 14 Days) |
|
| Intervention 2 |
|
| Washout 2 (3 to 14 Days) |
|
| Intervention 3 |
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | minutes*nanomolars (min*nM) | Predose up to 60 minutes postdose |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | minutes | Predose up to 480 minutes postdose |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | minutes | Predose up to 480 minutes postdose |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | minutes | Predose up to 480 minutes postdose |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of total AUC | Predose up to 120 minutes postdose |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | minutes | Predose up to 480 minutes postdose |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glulisine Alone | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone. | 0 | 14 | 1 | 14 | ||
| EG001 | Glulisine + rHuPH20 | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20). | 0 | 14 | 2 | 14 | ||
| EG002 | Lispro Alone | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone. | 0 | 14 | 2 | 14 | ||
| EG003 | Lispro + rHuPH20 | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20). | 0 | 14 | 3 | 14 | ||
| EG004 | Aspart Alone | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone. | 0 | 14 | 2 | 14 | ||
| EG005 | Aspart + rHuPH20 | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20). | 0 | 14 | 2 | 14 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion site anaesthesia | General disorders | MedDRA (11.0) | Systematic Assessment | The Organ System includes "administration site conditions." |
|
| Infusion site pain | General disorders | MedDRA (11.0) | Systematic Assessment | The Organ System includes "administration site conditions." |
|
| Infusion site abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Endocrinology Clinical Development | Halozyme Therapeutics, Inc. | (858) 794-8889 |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| C479079 | insulin glulisine |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Unknown or Not Reported |
|
|
| Mixed Models Analysis |
Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed. |
| <0.0001 |
Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing. |
| Geometric Least Squares Means Ratio |
| 5.26 |
| 2-Sided |
| 90 |
| 3.88 |
| 7.12 |
| No |
| Superiority or Other |
| Mixed Models Analysis | Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed. | <0.0001 | Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing. | Geometric Least Squares Means Ratio | 4.14 | 2-Sided | 90 | 3.05 | 5.60 | No | Superiority or Other |
| OG003 | Lispro + rHuPH20 | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20). |
| OG004 | Aspart Alone | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone. |
| OG005 | Aspart + rHuPH20 | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20). |
|
|
|
| OG003 | Lispro + rHuPH20 | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20). |
| OG004 | Aspart Alone | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone. |
| OG005 | Aspart + rHuPH20 | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20). |
|
|
| OG003 |
| Lispro + rHuPH20 |
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20). |
| OG004 | Aspart Alone | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone. |
| OG005 | Aspart + rHuPH20 | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20). |
|
|
| OG003 | Lispro + rHuPH20 | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20). |
| OG004 | Aspart Alone | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone. |
| OG005 | Aspart + rHuPH20 | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20). |
|
|
| OG003 | Lispro + rHuPH20 | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20). |
| OG004 | Aspart Alone | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone. |
| OG005 | Aspart + rHuPH20 | Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20). |
|
|