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Diabetes Mellitus, Type 1Phase 2NCT01194245

Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus

A Phase 2 study testing Insulin lispro, recombinant human hyaluronidase PH20 and Insulin aspart in people with Diabetes Mellitus, Type 1, run by Halozyme Therapeutics at 19 sites 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 purpose of the study is to compare Humalog (Insulin lispro)-recombinant human hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for the treatment of Type 1 Diabetes Mellitus (T1DM) in basal-bolus therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Insulin lispro, recombinant human hyaluronidase PH20 and Insulin aspart
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
19 sitesUnited States
Study dates
Aug 2010to Aug 2011
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females aged ≥18 years
  • Type 1 Diabetes Mellitus (T1DM) treated with insulin for ≥12 months
  • Body mass index (BMI) 18.0 to 40.0 kilograms per square meter (kg/m^2).
  • Hemoglobin A1C (HbA1C) level 6.7% to 8.2%, inclusive
  • Fasting C-peptide <0.6 nanograms per milliliter (ng/mL)
  • Willingness to use twice daily (BID) insulin glargine as basal insulin for the duration of the study
  • Willingness to avoid use of an insulin infusion pump or unblinded continuous glucose monitoring (CGM) during the study

Who cannot join

  • Known or suspected allergy to any component of any of the study drugs
  • Use of pramlintide within 30 days of Screening
  • Use of drugs during the study or within 30 days of Screening (such as corticosteroids or antimetabolites) that could interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia
  • Recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the Investigator

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Barbara Davis Center for Childhood Diabetes

    Aurora, Colorado, 80045

  • Mercury Street Medical

    Butte, Montana, 59701

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • AMCR Institute, Inc.

    Escondido, California, 92026

  • Desert Endocrinology

    Henderson, Nevada, 89052

  • Center for Diabetes and Endocrine Care

    Hollywood, Florida, 33021

  • Medstar Research Institute

    Hyattsville, Maryland, 20782

  • Rocky Mountain Diabetes and Osteoporosis Center

    Idaho Falls, Idaho, 83404

  • Scripps Whittier Diabetes Institute

    La Jolla, California, 92037

  • Diabetes Research Institute

    Miami, Florida, 33136

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • West Olympia Internal Medicine

    Olympia, Washington, 98502

  • Texas Diabetes and Endocrinology

    Round Rock, Texas, 78681

  • Cetero Research-San Antonio

    San Antonio, Texas, 78229

  • Mills-Peninsula Health Services

    San Mateo, California, 94401

  • University of Washington School of Medicine

    Seattle, Washington, 98105

  • Mid-America Diabetes Associates

    Wichita, Kansas, 67211

Other trials in United States

About this study

Official title: A Phase II, Randomized, Double Blind, 2-Way Crossover Safety and Efficacy Study of Subcutaneously Injected Prandial Insulins: Lispro-PH20 or Aspart-PH20 Compared to Insulin Lispro (Humalog®) in Patients With Type 1 Diabetes

The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for the treatment of Type 1 Diabetes Mellitus (T1DM) in basal-bolus therapy.

Read the detailed description

Criteria for randomization into the study included 1) fasting blood glucose and predinner glucose values in the range of 70 to 140 milligrams per deciliter (mg/dL) approximately 60% of the time for 7 days prior to randomization 2) 90 minute or 2-hour postprandial blood glucose <220 mg/dL approximately 70% of the time for 7 days prior to randomization and 3) successfully completed 3 days of 10-point glucose monitoring and have at least 4 self-monitored blood glucose values on all non-10-point monitoring days. Participants that did not meet 1 or more of these criteria during a 4- to 6-week Titration Period were not randomized.

Being tested
Insulin lispro, recombinant human hyaluronidase PH20, Insulin aspart, Insulin glulisine, Insulin glargine
Keywords
Type 1 diabetes
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • Insulin lisproDrug

    Also called Humalog

  • recombinant human hyaluronidase PH20Drug

    Also called Hylenex, rHuPH20, PH20

  • Insulin aspartDrug

  • Insulin glulisineDrug

    Also called Apidra

  • Insulin glargineDrug

    Also called Lantus

Study groups in NCT01194245
Study groupRoleWhat they receive
Lispro-PH20 / Insulin LisproExperimentalAll enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually. Next participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle with no washout period. Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
Receives: Drug: Insulin lispro; Drug: recombinant human hyaluronidase PH20; Drug: Insulin glulisine; Drug: Insulin glargine
Aspart-PH20 / Insulin LisproExperimentalAll enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually. Next participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle with no washout period. Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
Receives: Drug: Insulin lispro; Drug: recombinant human hyaluronidase PH20; Drug: Insulin aspart; Drug: Insulin glulisine; Drug: Insulin glargine

What is being measured

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

  1. Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period

    Glycosylated hemoglobin A1C (HBA1c) levels were measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). Least Squares (LS) means were calculated from mixed effects linear models with treatment (Lispro, Aspart), recombinant human hyaluronidase PH20 (rHuPH20; yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect.

    Measured: Baseline, Week 12 and Week 24

Secondary outcomes (5)

  1. Mean Daily Insulin Dose

    Prandial insulin doses were recorded during 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). The mean daily insulin dose over the 3 days during each treatment period is presented. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).

    Measured: Week 10 and Week 22

  2. Percentage of Participants Meeting Glucose Targets

    Participants were instructed to monitor their blood glucose levels a minimum of 4 times per day on all non-10-point glucose monitoring days. The number of participants meeting 90-minute postprandial plasma glucose (PPG) targets of <140 and <180 milligrams per deciliter (mg/dL) for at least 2/3 of values during non-10-point glucose monitoring days was recorded. The percentage was calculated by dividing the number of participants with values meeting the specified target at least 2/3 of the time by the total number of participants analyzed, multiplied by 100. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).

    Measured: Baseline through Week 24, excluding 10-point glucose monitoring days

  3. Rates of Hypoglycemia at the End of Each Treatment Period

    Overall rates of hypoglycemia (blood glucose ≤70 milligrams per deciliter [mg/dL] and <56 mg/dL) were calculated based on 4 weeks of observation for each treatment period. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

    Measured: Week 12 and Week 24

  4. Change From Baseline in Body Weight at the End of Each Treatment Period

    Body weight was measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).

    Measured: Baseline, Week 12 and Week 24

  5. Mean Daily Postprandial Glucose (PPG) Excursions

    Participants performed 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). Mean daily postprandial plasma glucose (PPG) excursions (referring to the change in blood glucose levels from before to after a meal) during 10-point glucose monitoring for breakfast, lunch, and dinner are presented. Data were collected 1 and 2 hours (hr) after each meal for 3 days and the means of each excursion are presented.

    Measured: Week 10 and Week 22

Timeline

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

  1. First posted2 Sep 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionAug 2011
  4. Study completionAug 2011

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01194245
Sponsor's protocol ID
HALO-117-205
Status last verified
Feb 2019
First submitted
31 Aug 2010
Last updated
26 Feb 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Insulin lispro, recombinant human hyaluronidase PH20 and Insulin aspart in people with Diabetes Mellitus, Type 1, run by Halozyme Therapeutics at 19 sites 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 7 inclusion and 4 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 26 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 19 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 19 Aug 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?

Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period (time frame: Baseline, Week 12 and Week 24). 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 NCT01194245.

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 26 Feb 2019.

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