Randomized, Double-blind, Crossover, PK and GD Study of CSII in Subjects With Type 1 Diabetes
This trial is active, not recruiting.
|Condition||type 1 diabetes mellitus|
|Treatments||insulin aspart alone, insulin aspart with rhuph20, insulin glulisine alone, insulin glulisine with rhuph20|
|Start date||December 2010|
|End date||May 2012|
|Trial size||36 participants|
|Trial identifier||NCT01275131, HALO-117-105|
The purpose of this study is to determine if rHuPH20 will change the exposure and action of approved insulin analogs when given by continuous subcutaneous infusion in people with Type 1 diabetes.
|Endpoint classification||pharmacokinetics/dynamics study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver, investigator)|
|Primary purpose||basic science|
Pharmacokinetic percent of area under the curve (PK% AUC)
time frame: 0 to 60 minutes
Determine and compare glucodynamic responses
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. Body mass index (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. Routine use of CSII as the primary route of insulin administration. 8. 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 (Exception: subjects in Stage 1 are permitted to participate in Stage 2). 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 Visit 1, 2, 4, or 5. 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. This applies both to new subjects and to subjects who have participated in Stage 1 and who wish to continue in Stage 2. 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 Visit 1 (Stage 1) or Visit 4 (Stage 2) in this study.
|Official title||Randomized, Double-Blind, Pharmacokinetic (PK) and Glucodynamic (GD) Crossover Study of Continuous Subcutaneous Insulin Infusion (CSII) of Rapid Acting Insulin Analogs With and Without Recombinant Human Hyaluronidase (rHuPH20)|
|Principal investigator||Linda Morrow, MD|
|Description||Previous clinical studies of insulin coadministered with rHuPH20 have demonstrated insulin pharmacokinetics (PK) that better replicate the natural insulin response to a meal in healthy individuals. Specifically, coadministration of insulin with rHuPH20 accelerates the onset of insulin action (early t50% max), the time of peak insulin concentration (tmax), and the offset of insulin action (late t50%max). rHuPH20 coadministration also increases the peak insulin concentration, increases early insulin exposure, and reduces late postprandial insulin exposure. In healthy volunteers, this acceleration of insulin exposure results in accelerated glucose metabolism, as measured by glucose infusion rates during a euglycemic clamp. In subjects with Type 1 and Type 2 diabetes mellitus, the acceleration of insulin exposure has been shown to reduce postprandial hyperglycemia, as measured by peak blood glucose, two-hour postprandial glucose, and total area of glucose excursions >140 mg/d occurring in response to a standardized liquid test meal. This study is designed to compare the PK of insulin analogs when they are infused with and without rHuPH20. In addition to comparisons of various PK and glucodynamic measures, safety and tolerability of insulin analogs alone and with rHuPH20 during continuous infusion of each study drug in subjects with Type 1 diabetes mellitus will be evaluated.|
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