CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM)
NCT ID: NCT01848990
Last Updated: 2018-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
456 participants
INTERVENTIONAL
2013-03-31
2014-09-30
Brief Summary
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Detailed Description
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Total duration of study treatment is 24 months. However, according to the study design, the primary outcome measure is to be assessed at 6 months and an interim analysis is to be completed at 6 months for the secondary outcome measures and adverse events. Therefore, data reported in this clinical trials record is for the 6-month interim analysis.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Commercial Hylenex Recombinant (Formulation 1)
Hylenex Formulation 1: For 6 months, participants received their regular treatment of rapid-acting continuous subcutaneous insulin infusion (CSII) (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the commercial form of Hylenex recombinant, delivered at 150 units (U) through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
Commercial Hylenex® recombinant (hyaluronidase human injection)
Insulin lispro
Insulin aspart
Insulin glulisine
Precommercial Hylenex Recombinant (Formulation 2)
Hylenex Formulation 2: For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the precommercial form of Hylenex recombinant, delivered at 150 units (U) through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
Precommercial Hylenex recombinant (hyaluronidase human injection)
Insulin lispro
Insulin aspart
Insulin glulisine
Standard Rapid-Acting Insulin CSII
Participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
Insulin lispro
Insulin aspart
Insulin glulisine
Interventions
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Commercial Hylenex® recombinant (hyaluronidase human injection)
Precommercial Hylenex recombinant (hyaluronidase human injection)
Insulin lispro
Insulin aspart
Insulin glulisine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Glycosylated hemoglobin (HbA1c) 6.5% to 9.5% (inclusive) based on central laboratory results
3. Fasting C-peptide \<0.6 nanograms per milliliter (ng/mL)
4. Current use of an insulin pump compatible with available tubing for Hylenex recombinant infusion and use of an infusion set compatible with the tubing available or willingness to switch to an infusion set compatible with tubing available for infusion of Hylenex recombinant
5. Current treatment at the time of screening with insulin \<300 units per day (U/day)
6. Participants who routinely use continuous glucose monitoring (CGM) (defined as average CGM use 5 or more days per week over the preceding 3 months) and those who do not routinely used CGM are both eligible for inclusion in the study. Intermittent use of CGM is also acceptable but will not be a criterion use for stratified randomization.
7. Participants should be in good general health based on medical history and physical examination, without medical conditions that might prevent the completion of study drug infusions and assessments required in this protocol.
Exclusion Criteria
2. Known or suspected allergy to any component of any of the study drugs in this study
3. Severe proliferative retinopathy or maculopathy, and/or gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, of such severity as to impede the participant's ability to comply with protocol procedures, as judged by the Investigator
4. History of transmural myocardial infarction, congestive heart failure and uncontrolled hypertension (diastolic blood pressure \[BP\] consistently \>100 millimeters of mercury \[mmHg\]) are exclusionary
5. As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including history of stroke, history of arrhythmia, or conduction delays on electrocardiogram \[ECG\]), hepatic, neurological, renal, genitourinary, pulmonary, or hematological systems of such severity as to impede the participant's ability to comply with protocol procedures
6. History of any illness or disease that in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the study drugs to the participant
7. As judged by the Investigator, clinically significant findings in routine laboratory data at screening
8. Use of drugs that may interfere with the interpretation of study results or are known to cause clinically relevant interference with hyaluronidase action, insulin action, glucose utilization, or recovery from hypoglycemia (including systemic pharmacologic corticosteroid). Use of pramlintide or a glucagon-like peptide \[GLP\]-1 receptor agonist is not exclusionary but participants using these agents will be subjected to stratified randomization. Use of aspirin (acetylsalicylic acid \[ASA\]) up to 325 milligrams (mg)/day is not exclusionary but should be noted for analysis.
9. Hypoglycemic unawareness of such severity as to impede the participant's ability to comply with protocol procedures, as judged by the Investigator.
10. Current addiction to alcohol or substance abuse as determined by the Investigator.
11. Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device \[IUD\], oral or injectable contraceptives, and/or barrier methods). Abstinence alone is not considered an adequate contraceptive measure for the purposes of this study.
12. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study
18 Years
ALL
No
Sponsors
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Halozyme Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Douglas Muchmore, MD
Role: STUDY_DIRECTOR
Halozyme Therapeutics
Locations
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For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time
Concord, California, United States
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Encino, California, United States
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Escondido, California, United States
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Greenbrae, California, United States
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La Jolla, California, United States
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San Mateo, California, United States
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Aurora, Colorado, United States
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Hollywood, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Atlanta, Georgia, United States
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Roswell, Georgia, United States
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Idaho Falls, Idaho, United States
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Des Moines, Iowa, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Hyattsville, Maryland, United States
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Rockville, Maryland, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Butte, Montana, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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New Hyde Park, New York, United States
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Asheville, North Carolina, United States
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Durham, North Carolina, United States
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Morehead City, North Carolina, United States
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Cincinnati, Ohio, United States
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Portland, Oregon, United States
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Bartlett, Tennessee, United States
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Chattanooga, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Round Rock, Texas, United States
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San Antonio, Texas, United States
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Olympia, Washington, United States
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Renton, Washington, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
Countries
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Related Links
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Related Info
Other Identifiers
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Halo-117-403
Identifier Type: -
Identifier Source: org_study_id
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