Diabetes Mellitus, Type IIPhase 2NCT01194258
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing Insulin lispro, Insulin aspart and Recombinant human hyaluronidase PH20 in people with Diabetes Mellitus, Type II, run by Halozyme Therapeutics at 22 sites in United States.
Trial summary
The purpose of the study was to compare Humalog (insulin lispro)-recombinant human hyaluronidase PH20 (rHuPH20) or Novolog (insulin aspart)-rHuPH20 to insulin lispro for the treatment of Type 2 diabetes mellitus (T2DM) 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 II
- What is being tested?
- Insulin lispro, Insulin aspart and Recombinant human hyaluronidase PH20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 22 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 ≥18 years
- Type 2 diabetes mellitus (T2DM) treated with insulin ≥12 months and prandial insulin (at least 2 meals per day) for ≥2 months
- Body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m^2)
- Glycosylated hemoglobin (HbA1C) level 7.0 to 8.5%, inclusive
- Fasting C-peptide <0.6 nanograms per milliliter (ng/mL)
- Willingness to use insulin glargine twice a day 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
- Exclusive use of pre-mixed insulins
- Use of pramlintide, exenatide, and/or liraglutide within 30 days of screening
- Use of sulfonylureas within two months of screening
- Use of drugs (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, during the study or within 30 days of screening
- Recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the investigator
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Mercury Street Medical
Butte, Montana, 59701
John Muir Physician Network Clinical Research Center
Concord, California, 94520
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
Henry Ford Health System
Detroit, Michigan, 48202
Medical Group of Encino
Encino, California, 91436
AMCR Institute, Inc.
Escondido, California, 92026
Marin Endocrine Care and Research
Greenbrae, California, 94904
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
Diabetes Research Institute
Miami, Florida, 33136
Baptist Diabetes Associates
Miami, Florida, 33156
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
Diabetes and Endocrinology Associates, PC
Rudd, North Carolina, 28557
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
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 2 Diabetes
The purpose of the study was to compare Humalog (insulin lispro)-recombinant human hyaluronidase PH20 (rHuPH20) or Novolog (insulin aspart)-rHuPH20 to insulin lispro for the treatment of Type 2 diabetes mellitus (T2DM) in basal-bolus therapy.
Read the detailed description
Criteria for randomization into the study included 1) fasting blood glucose and pre-dinner 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 completing 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.
- Conditions
- Diabetes Mellitus, Type II
- Being tested
- Insulin lispro, Insulin aspart, Recombinant human hyaluronidase PH20, Insulin glulisine, Insulin glargine
- Keywords
- Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin lisproDrug
Also called Lispro, Humalog
Insulin aspartDrug
Also called Aspart, Novolog
Recombinant human hyaluronidase PH20Drug
Also called rHuPH20, PH20, Hylenex
Insulin glulisineDrug
Also called Apidra
Insulin glargineDrug
Also called Lantus
| Study group | Role | What they receive |
|---|---|---|
| Lispro-PH20/Insulin lispro | Experimental | All enrolled participants underwent a titration period of 4 to 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.
Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (combined: Lispro-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 Lispro | Experimental | All enrolled participants underwent a titration period of 4 to 6 weeks in which they received 100 U/mL insulin glulisine, injected 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.
Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 µg/mL rHuPH20 (combined: Aspart-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: Insulin aspart; Drug: Recombinant human hyaluronidase PH20; Drug: Insulin glulisine; Drug: Insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment Period
Change in glycosylated hemoglobin A1C (HbA1C) from baseline (Week 0) to end of treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-recombinant human hyaluronidase PH20 (PH20) + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). Least squares (LS) means were calculated from linear contrasts of mixed effects linear models with treatment (Lispro, Aspart), PH20 (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)
Mean Daily Insulin Dose as Recorded During 10-Point Glucose Monitoring
Mean daily insulin dose as recorded during 10-point glucose monitoring is reported. Blood glucose values were obtained during 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) at the following timepoints: immediately prior to breakfast (fasting), 1 hour (hr) after breakfast, 2 hr after breakfast, immediately prior to lunch, 1 hr after lunch, 2 hr after lunch, immediately prior to dinner, 1 hr after dinner, 2 hr after dinner, and at 03:00. A minimum of 7 determinations were required for each day during the 3 days of 10-point glucose profiles. Prandial insulin doses were also recorded during the 10-point glucose monitoring and the mean daily insulin dose over the 3 days was calculated. Data are 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
Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time
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 was recorded during non-10-point glucose monitoring was recorded. The number of participants was recorded, and the percentage of participants meeting glucose targets was calculated by 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
Rates of Hypoglycemia at the End of Each Treatment Period
The rate of hypoglycemia, defined as blood glucose levels ≤70 mg/dL and <56 mg/dL, was calculated based on 4 weeks of observation prior to the end of treatment period (that is, 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 groups). 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
Change From Baseline in Body Weight at the End of Each Treatment Period
Change from baseline in body weight at the end of each treatment period (Week 12 and Week 24) is presented. Data are 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
Mean Daily 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 PPG excursions during 10-point glucose monitoring for breakfast, lunch, and dinner from Treatment Period 1 or Treatment Period 2 are presented. PPG refers to the change in glucose concentration before to after a meal. Data were collected 1 and 2 hours (hr) after each meal. Data are 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halozyme Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas Muchmore, M.D., Study director, Halozyme Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194258
- Sponsor's protocol ID
- HALO-117-206
- Status last verified
- Aug 2014
- First submitted
- 31 Aug 2010
- Last updated
- 20 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 2 Diabetes
- ClinicalTrials.gov ID
- NCT01194258
- Acronym / sponsor ID
- HALO-117-206
- Conditions
- Diabetes Mellitus, Type II
- Keywords
- Type 2 diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Halozyme TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 2 Sep 2010 (estimated)
- Results
- Posted 20 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study was to compare Humalog (insulin lispro)-recombinant human hyaluronidase PH20 (rHuPH20) or Novolog (insulin aspart)-rHuPH20 to insulin lispro for the treatment of Type 2 diabetes mellitus (T2DM) in basal-bolus therapy.
Detailed description
Criteria for randomization into the study included 1) fasting blood glucose and pre-dinner 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 completing 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lispro-PH20/Insulin lispro | Experimental | Drug: Insulin lispro, Drug: Recombinant human hyaluronidase PH20, Drug: Insulin glulisine, Drug: Insulin glargineAll enrolled participants underwent a titration period of 4 to 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. Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (combined: Lispro-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. |
| Aspart-PH20/Insulin Lispro | Experimental | Drug: Insulin lispro, Drug: Insulin aspart, Drug: Recombinant human hyaluronidase PH20, Drug: Insulin glulisine, Drug: Insulin glargineAll enrolled participants underwent a titration period of 4 to 6 weeks in which they received 100 U/mL insulin glulisine, injected 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. Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 µg/mL rHuPH20 (combined: Aspart-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females ≥18 years
- Type 2 diabetes mellitus (T2DM) treated with insulin ≥12 months and prandial insulin (at least 2 meals per day) for ≥2 months
- Body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m^2)
- Glycosylated hemoglobin (HbA1C) level 7.0 to 8.5%, inclusive
- Fasting C-peptide <0.6 nanograms per milliliter (ng/mL)
Key exclusion criteria (6 listed)
- Known or suspected allergy to any component of any of the study drugs
- Exclusive use of pre-mixed insulins
- Use of pramlintide, exenatide, and/or liraglutide within 30 days of screening
- Use of sulfonylureas within two months of screening
- Use of drugs (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, during the study or within 30 days of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin lisproAlso: Lispro, Humalog | Drug | Aspart-PH20/Insulin Lispro, Lispro-PH20/Insulin lispro |
| Insulin aspartAlso: Aspart, Novolog | Drug | Aspart-PH20/Insulin Lispro |
| Recombinant human hyaluronidase PH20Also: rHuPH20, PH20, Hylenex | Drug | Aspart-PH20/Insulin Lispro, Lispro-PH20/Insulin lispro |
| Insulin glulisineAlso: Apidra | Drug | Aspart-PH20/Insulin Lispro, Lispro-PH20/Insulin lispro |
| Insulin glargineAlso: Lantus | Drug | Aspart-PH20/Insulin Lispro, Lispro-PH20/Insulin lispro |
Primary outcome
Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment Period
Time frame: Baseline, Week 12 and Week 24
Change in glycosylated hemoglobin A1C (HbA1C) from baseline (Week 0) to end of treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-recombinant human hyaluronidase PH20 (PH20) + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). Least squares (LS) means were calculated from linear contrasts of mixed effects linear models with treatment (Lispro, Aspart), PH20 (yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect.
5 secondary outcomes
Mean Daily Insulin Dose as Recorded During 10-Point Glucose Monitoring
Time frame: Week 10 and Week 22
Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time
Time frame: Baseline through Week 24, excluding 10-point glucose monitoring days
Rates of Hypoglycemia at the End of Each Treatment Period
Time frame: Week 12 and Week 24
Change From Baseline in Body Weight at the End of Each Treatment Period
Time frame: Baseline, Week 12 and Week 24
Mean Daily PPG Excursions
Time frame: Week 10 and Week 22
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Muchmore, M.D. study director
Halozyme Therapeutics
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Insulin lispro, Insulin aspart and Recombinant human hyaluronidase PH20 in people with Diabetes Mellitus, Type II, run by Halozyme Therapeutics at 22 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 6 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 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 20 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?
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 20 Aug 2014.