- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01194245
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus
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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Escondido, California, United States, 92026
- AMCR Institute, Inc.
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La Jolla, California, United States, 92037
- Scripps Whittier Diabetes Institute
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San Mateo, California, United States, 94401
- Mills-Peninsula Health Services
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Colorado
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Aurora, Colorado, United States, 80045
- Barbara Davis Center for Childhood Diabetes
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Florida
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Hollywood, Florida, United States, 33021
- Center for Diabetes and Endocrine Care
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Miami, Florida, United States, 33136
- Diabetes Research Institute
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Rocky Mountain Diabetes and Osteoporosis Center
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Kansas
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Wichita, Kansas, United States, 67211
- Mid-America Diabetes Associates
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane University Health Sciences Center
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Maryland
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Hyattsville, Maryland, United States, 20782
- Medstar Research Institute
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
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Minnesota
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Minneapolis, Minnesota, United States, 55416
- International Diabetes Center
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Montana
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Butte, Montana, United States, 59701
- Mercury Street Medical
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Nevada
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Henderson, Nevada, United States, 89052
- Desert Endocrinology
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Texas
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Dallas, Texas, United States, 75390
- UT Southwestern Medical Center at Dallas
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Round Rock, Texas, United States, 78681
- Texas Diabetes and Endocrinology
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San Antonio, Texas, United States, 78229
- Cetero Research-San Antonio
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Washington
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Olympia, Washington, United States, 98502
- West Olympia Internal Medicine
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Seattle, Washington, United States, 98105
- University of Washington School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lispro-PH20 / Insulin Lispro
All 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. |
Other Names:
Other Names:
Other Names:
Other Names:
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Experimental: Aspart-PH20 / Insulin Lispro
All 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. |
Other Names:
Other Names:
Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period
Time Frame: Baseline, Week 12 and Week 24
|
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.
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Baseline, Week 12 and Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Daily Insulin Dose
Time Frame: Week 10 and Week 22
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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).
|
Week 10 and Week 22
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Percentage of Participants Meeting Glucose Targets
Time Frame: Baseline through Week 24, excluding 10-point glucose monitoring days
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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).
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Baseline through Week 24, excluding 10-point glucose monitoring days
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Rates of Hypoglycemia at the End of Each Treatment Period
Time Frame: Week 12 and Week 24
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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.
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Week 12 and Week 24
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Change From Baseline in Body Weight at the End of Each Treatment Period
Time Frame: Baseline, Week 12 and Week 24
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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).
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Baseline, Week 12 and Week 24
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Mean Daily Postprandial Glucose (PPG) Excursions
Time Frame: Week 10 and Week 22
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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.
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Week 10 and Week 22
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Douglas Muchmore, M.D., Halozyme Therapeutics
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
- Insulin, Globin Zinc
- Insulin Aspart
- Insulin Glargine
- Insulin Lispro
- Insulin glulisine
Other Study ID Numbers
- HALO-117-205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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