Phase 4
Completed N=25
Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase
Source: ClinicalTrials.gov NCT01526733 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Early Insulin Exposure (%AUC[0-60]) — 33.53; 17.85; 39.45; 33.52 percentage of AUC(0-60) — p=<0.0001
Summary
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 units (U) of Hylenex® (recombinant human hyaluronidase PH20 [rHuPH20]) injection at the time of infusion set insertion compared to sham injection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Early Insulin Exposure (%AUC[0-60]) |
33.53; 17.85; 39.45; 33.52 | <0.0001 sig |
| SECONDARY Maximum Glucose Infusion Rate (GIRmax) |
13.47; 11.14; 10.75; 11.83 | — |
| SECONDARY Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax) |
78.95; 132.62; 81.86; 97.38 | — |
| SECONDARY Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max) |
40.33; 54.67; 114.52; 152.14; 32.57; 39.67 | — |
| SECONDARY Time to 50% Total Glucose Infused (50%Gtot) |
40.33; 32.57; 54.67; 39.67 | — |
| SECONDARY Area Under the Glucose Concentration Curve (AUC[0-360]) |
1312.41; 1199.54; 1063.77; 1139.65 | — |
| SECONDARY Duration of Insulin Action (AUMC[0-360]/AUC[0-360]) |
119.02; 154.03; 111.25; 120.57 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females 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.
- Non-smoking participants with Type 1 diabetes mellitus (T1DM) treated with insulin for ≥12 months. Nonsmoking means abstinence from cigarettes and cigars for 3 months and negative cotinine screening tests at screening.
- Body mass index (BMI) 18.0 to 35.0 kilograms per meter squared (kg/m²), inclusive.
- Glycosylated hemoglobin A1c (HbA1c) ≤10% based on local laboratory results.
- Fasting connecting peptide of insulin (C-peptide) 500 milliliters [mL]) within the previous 8 weeks of the Screening Visit(s) in this study.
- Pregnancy, breastfeeding, 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).
- Symptomatic gastroparesis.
- Receipt of any investigational drug within 4 weeks of Study Day 1.
Data sourced from ClinicalTrials.gov (NCT01526733). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.