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HealthyPhase 1NCT00979875

A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone

A Phase 1 study testing Recombinant human hyaluronidase PH20 (rHuPH20), Insulin lispro and Insulin glulisine in people with Healthy, run by Halozyme Therapeutics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 +… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Recombinant human hyaluronidase PH20 (rHuPH20), Insulin lispro and Insulin glulisine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
Sep 2009to May 2010
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Profil Institute for Clinical Research, Inc.

    Chula Vista, California, 91911

Other trials in United States

About this study

Official title: Phase 1, Randomized, Double-Blind, Pharmacokinetic and Glucodynamic, 6-Way Crossover Study of Subcutaneously Administered Insulin Analogs With Recombinant Human Hyaluronidase (rHuPH20) Compared to Insulin Analogs Alone in Healthy Volunteers

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.

Conditions
Healthy
Being tested
Recombinant human hyaluronidase PH20 (rHuPH20), Insulin lispro, Insulin glulisine, Insulin aspart
Keywords
insulin, recombinant human hyaluronidase, Healthy volunteers
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant human hyaluronidase PH20 (rHuPH20)Drug

    Also called HYLENEX, PH20

  • Insulin lisproDrug

    Also called Humalog, Lispro

  • Insulin glulisineDrug

    Also called Apidra, Glulisine

  • Insulin aspartDrug

    Also called NovoLog, Aspart

Study groups in NCT00979875
Study groupRoleWhat they receive
Lispro+PH20, Lispro, Glulis+PH20, Glulis, Aspart+PH20, AspartExperimentalAll 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.
Receives: Drug: Recombinant human hyaluronidase PH20 (rHuPH20); Drug: Insulin lispro; Drug: Insulin glulisine; Drug: Insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Predose up to 60 minutes postdose

Secondary outcomes (5)

  1. 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.

    Measured: Predose up to 480 minutes postdose

  2. 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.

    Measured: Predose up to 480 minutes postdose

  3. 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.

    Measured: Predose up to 480 minutes postdose

  4. 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.

    Measured: Predose up to 120 minutes postdose

  5. 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.

    Measured: Predose up to 480 minutes postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionFeb 2010
  4. Study completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00979875
Sponsor's protocol ID
HALO-117-104
Status last verified
Jun 2014
First submitted
17 Sep 2009
Last updated
14 Jul 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 23043164

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Recombinant human hyaluronidase PH20 (rHuPH20), Insulin lispro and Insulin glulisine in people with Healthy, run by Halozyme Therapeutics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60) (time frame: Predose up to 60 minutes postdose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00979875, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2014.

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