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Type 1 Diabetes MellitusPhase 4HALO-117-406NCT03662334

A Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Function in Subjects With Type 1 Diabetes With Recombinant Human Hyaluronidase (rHuPH20)

A Phase 4 study testing Rapid Acting insulin with pre-treatment of rHuPH20 in people with Type 1 Diabetes Mellitus, 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

The goal of this study is to determine if Hylenex recombinant leads to changes in the insulin time-action profiles and glucose responses when preadministered in the setting of continuous subcutaneous insulin infusion (CSII) compared to CSII without Hylenex recombinant (sham injection). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Rapid Acting insulin with pre-treatment of rHuPH20
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
14 participants
Where
1 siteUnited States
Study dates
3 Oct 2013to 27 Feb 2014
Phase
Phase 4
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female participants between the ages 18 and 65 years, inclusive.
  • Females of child-bearing potential must agree to use a standard and effective means of birth control for the duration of the study. Adequate contraceptive measures include oral or injectable contraceptives, sterilization, intra-uterine device (IUD), barrier methods, or abstinence.
  • Participants with type 1 diabetes mellitus treated with insulin (multiple daily injections or continuous subcutaneous insulin infusion [CSII]) diagnosed ≥ 12 months prior to enrollment
  • Body mass index (BMI) 18.0 to 32.0 kilograms per meters squared (kg/m^2)
  • HbA1c (glycated hemoglobin A1c) ≤ 10% based on local laboratory results
  • Fasting C-peptide < 0.6 nanograms per milliliter (ng/mL)
  • Current treatment with insulin <1.2 Units per kg per day (U/kg/day)
  • Participant should be in good general health based on medical history and physical examination, without medical conditions that might prevent the completion of study drug injections and assessments required in this protocol

Who cannot join

  • Inability to comply with study requirements as judged by the Investigator
  • Known or suspected allergy to any component of any of the study drugs in this trial
  • A participant who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
  • As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including a history of arrhythmia or conduction delays on electrocardiogram), hepatic, neurological, renal, genitourinary, or hematological systems
  • As judged by the Investigator, uncontrolled hypertension (diastolic blood pressure ≥ 100 millimeters of mercury [mmHg] and/or systolic blood pressure ≥ 160 mmHg after 5 minutes in the supine position)
  • History of any illness or disease that in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the study drugs to the participant
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  • As judged by the Investigator, clinically significant findings in routine laboratory data. Anemia with hemoglobin less than lower limits of normal at screening is specifically exclusionary
  • Use of drugs that may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia, or drugs not permitted according to Hylenex recombinant package insert
  • Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator
  • Current addiction to alcohol or substances of abuse as determined by the Investigator
  • Blood donation (> 500 mL) within the previous 8 weeks (56 days) prior to Day -1 of Treatment Period 1
  • Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, IUD, oral or injectable contraceptives, or barrier methods)
  • Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study
  • Participation in any other clinical trial and receipt of any investigational drug within 4 weeks of Day -1 of Treatment Period 1
  • Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will interfere with trial participation or evaluation of data
  • Positive for human immunodeficiency virus (HIV), Hepatitis C or Hepatitis B
  • Tobacco and nicotine use within 3 months prior to Day 1 of Treatment Period 1 or use during the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Profil Institute for Clinical Research

    Chula Vista, California, 91911

Other trials in United States

About this study

Official title: A Phase 4, Double Blind, Single Center, Randomized, Cross-Over Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Functionality in Subjects With Type 1 Diabetes Comparing Pretreatment vs. No Pretreatment With Recombinant Human Hyaluronidase (rHuPH20)

The goal of this study is to determine if Hylenex recombinant leads to changes in the insulin time-action profiles and glucose responses when preadministered in the setting of continuous subcutaneous insulin infusion (CSII) compared to CSII without Hylenex recombinant (sham injection).

Read the detailed description

There is a recognized need for more rapid insulin action than is available from current rapid-acting analog products. In addition, current products have inconstant absorption and action profiles over the course of infusion set life. Previous human studies of prandial insulin preparations have used co-mixtures of rHuPH20 (study drug) with insulin delivered to study participants by subcutaneous injection and have demonstrated acceleration of insulin absorption and action. CSII has been used clinically for the treatment of diabetes over the last three decades, and a previous study using a co-mixture of rHuPH20 during CSII showed that the combination resulted in a more consistent and ultrafast profile of insulin absorption and action across infusion set use as compared to rapid analog insulin alone.

Being tested
Rapid Acting insulin with pre-treatment of rHuPH20, Sham injection
Keywords
Diabetes, Type 1 Diabetes Mellitus, Type 1 Diabetes, T1DM, Continuous Subcutaneous Insulin Infusion (CSII), CSII, Insulin pump, Insulin, rHuPH20, Hylenex, recombinant human hyaluronidase (rHuPH20), Recombinant hyaluronidase
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance

What participants receive

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

  • Rapid Acting insulin with pre-treatment of rHuPH20Drug

    Also called Humalog, Hylenex

    Hylenex recombinant will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area.

  • Sham injectionDevice

    Also called placebo

    A sham injection will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area.

Study groups in NCT03662334
Study groupRoleWhat they receive
Hylenex recombinantExperimentalComparing the preadministration of Hylenex recombinant in the setting of continuous subcutaneous insulin infusion (CSII).
Receives: Drug: Rapid Acting insulin with pre-treatment of rHuPH20
Sham InjectionSham comparatorComparing the preadministration of a sham injection in the setting of CSII.
Receives: Device: Sham injection

What is being measured

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

  1. Part 1: Area Under the Curve (AUC) of Glucose Infusion Rate (GIR) From 0-6 Hours

    Measured: 0-6 hours

  2. Part 2: Time to Reduction in Plasma Glucose by 80 Milligrams Per Deciliter (mg/dL) Following CSII Bolus

    Time to reduction is reported as the maximum time it took for any participant receiving each treatment sequence to achieve a reduction in plasma glucose by 80 mg/dL. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.

    Measured: 0-10 hours

  3. Part 3: Time to Achieve Plasma Glucose >90 mg/dL After Release of Hypoglycemic CSII Clamp

    Measured: 0-12 hours

Secondary outcomes (13)

  1. Part 1: Time-action Profile, Assessed by GIR in Euglycemic Participants

    Measured: up to approximately 10 hours

  2. Part 1: Mean Maximum Concentration (Cmax)

    Measured: up to approximately 22 hours

  3. Part 1: Time to Achieve Maximum Concentration (Tmax)

    Measured: up to approximately 22 hours

  4. Part 1: Early Time to 50% Maximum Serum Insulin Concentration (t50%) Max

    Measured: up to approximately 22 hours

  5. Part 1: Time to 50% of Total AUC (AUC0-last)

    Measured: up to approximately 22 hours

  6. Part 1: Fractional and Absolute AUC0-1hr

    Measured: 0 to 1 hour

  7. Part 1: Fractional and Absolute AUC2hr-end

    Measured: 2 to approximately 22 hours

  8. Part 1: Area Under the Curve From Time Zero to the Last Measureable Concentration (AUC0-last)

    Measured: up to approximately 22 hours

  9. Part 1: Mean Residence Time (MRT)

    Measured: up to approximately 22 hours

  10. Part 2: Plasma Glucose Concentration Over Time

    Plasma glucose concentration over time is reported as the maximum concentration for any participant receiving each treatment sequence. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.

    Measured: up to approximately 10 hours

  11. Part 2: Insulin Analog Serum Concentration as a Function of Time Following Bolus Insulin Infusion

    Insulin analog serum concentration is reported as the maximum concentration for any participant receiving each treatment sequence. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.

    Measured: up to approximately 10 hours

  12. Part 3: Plasma Glucose Concentration Over Time

    Measured: up to approximately 12 hours

  13. Part 3: Insulin Analog Serum Concentration as a Function of Time Following Termination of Insulin Infusion

    Measured: up to approximately 12 hours

Timeline

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

  1. First posted7 Sep 2018
  2. Study start3 Oct 2013
  3. Primary completion27 Feb 2014
  4. Study completion27 Feb 2014

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03662334
Sponsor's protocol ID
HALO-117-406
Acronym
HALO-117-406
Status last verified
Jan 2019
First submitted
13 Aug 2018
Last updated
1 Feb 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rapid Acting insulin with pre-treatment of rHuPH20 in people with Type 1 Diabetes Mellitus, 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 8 inclusion and 17 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 1 Feb 2019. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 1 Feb 2019). 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?

Part 1: Area Under the Curve (AUC) of Glucose Infusion Rate (GIR) From 0-6 Hours (time frame: 0-6 hours). The study lists 3 primary outcomes in all. 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 NCT03662334.

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 1 Feb 2019.

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HALO-117-406 Clinical Trial NCT03662334 | AzTrials