Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Sham Injection; Recombinant human hyaluronidase PH20; Insulin aspart; Insulin lispro
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Lispro
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Type 1 Diabetes; Continuous Subcutaneous Insulin Infusion (CSII)

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. 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.

          3. Body mass index (BMI) 18.0 to 35.0 kilograms per meter squared (kg/m²), inclusive.

          4. Glycosylated hemoglobin A1c (HbA1c) ≤10% based on local laboratory results.

          5. Fasting connecting peptide of insulin (C-peptide) <0.6 nanograms per milliliter
             (ng/mL).

          6. Current treatment with insulin <90 units per day (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 3
             months prior to screening

          9. 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 the study protocol.

        Exclusion Criteria:

          1. Known or suspected allergy to any component of any of the study drugs in this study.

          2. Previous enrollment in this study.

          3. Use of drugs that may interfere with the interpretation of study results or are known
             to cause clinically relevant interference with insulin action, glucose utilization, or
             recovery from hypoglycemia. Participants taking maintenance doses of blood thinners
             (for example, coumadin or heparin) will be excluded.

          4. Use of any long-acting insulin injection within 72 hours of Study Day 1; participants
             will continue to refrain from use throughout the duration of the study (Phases I and
             II).

          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 milliliters [mL]) within the previous 8 weeks of
             the Screening Visit(s) in this study.

          8. 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).

          9. Symptomatic gastroparesis.

         10. Receipt of any investigational drug within 4 weeks of Study Day 1.