Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase
This trial is active, not recruiting.
|Condition||type 1 diabetes mellitus|
|Treatments||sham injection, rapid acting insulin with pre-treatment of rhuph20|
|Start date||December 2011|
|End date||August 2012|
|Trial size||25 participants|
|Trial identifier||NCT01526733, Halo-117-401|
The purpose of this study is to evaluate consistency of accelerated insulin absorption and onset-of-action and shortened duration of action for bolus insulin infusions after pretreatment with 150 U of Hylenex® recombinant (hyaluronidase human injection)(rHuPH20) at the time of infusion set insertion compared to sham injection.
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver, investigator)|
Insulin absorption assessed by the amount of insulin exposure within the first hour following bolus insulin infusion.
time frame: 0-60 minutes
Glycemic Excursions with and without pre-treatment with Hylenex recombinant.
time frame: 72 Hours
Changes in insulin absorption with and without pre-treatment with Hylenex recombinant.
time frame: 72 hours
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: 1. Male or female of age 18 to 65 years, inclusive. Females of child-bearing potential must use a standard and effective means of birth control for the duration of the study. 2. Non-smoking subjects with Type 1 diabetes mellitus treated with insulin for ≥12 months. Nonsmoking means abstinence from cigarettes and cigars for 3 months and negative cotinine screening tests at screening. 3. BMI 18.0 to 35.0 kg/m², inclusive. 4. HbA1c (glycosylated hemoglobin A1c) ≤ 10 % based on local laboratory results. 5. Fasting C-peptide < 0.6 ng/mL. 6. Current treatment with insulin < 90 U/d. 7. Current use of Rapid Acting Insulin Analog. 8. Routine use of CSII as the primary route of insulin administration for at least three months prior to screening 9. Subject 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: 1. Known or suspected allergy to any component of any of the study drugs in this trial. 2. Previous enrollment in this trial 3. 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. Subjects taking maintenance doses of blood thinners (e.g. Coumadin or heparin) will be excluded. 4. Use of any long acting insulin injection within 72 hours of Study Day 1 continuing to refrain from use throughout the duration of the study, Phases 1 and 2. 5. Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator. 6. Current addiction to alcohol or substances of abuse as determined by the Investigator. 7. Blood donation or phlebotomy (> 500 mL) within the previous 8 weeks of the Screening Visit(s) in this study. 8. 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, or barrier methods). 9. Symptomatic gastroparesis. 10. Receipt of any investigational drug within 4 weeks of Study Day 1.
|Official title||A Phase 4, Randomized, Double-Blind, 2-Way Crossover Study of Continuous Subcutaneous Insulin Infusion (CSII) With, Compared to Without, Pretreatment With Recombinant Human Hyaluronidase (rHuPH20)|
|Principal investigator||Linda Morrow, MD|
|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 subjects by subcutaneous injection and have demonstrated acceleration of insulin absorption and action. Continuous subcutaneous insulin infusion (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. The present study will evaluate the ability of rHuPH20 pretreatment to confer a consistent ultrafast profile of absorption and action to rapid analog insulin products across the life of infusion sets.|
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