A Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Function in Subjects With Type 1 Diabetes With Recombinant Human Hyaluronidase (rHuPH20)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Rapid Acting insulin with pre-treatment of rHuPH20; Sham injection
Intervention description: Hylenex recombinant will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area.; A sham injection will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area.
Intervention MeSH terms: Insulin, Short-Acting
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Diabetes; Type 1 Diabetes Mellitus; Type 1 Diabetes; T1DM; Continuous Subcutaneous Insulin Infusion (CSII); CSII; Insulin pump; Insulin; rHuPH20; Hylenex; recombinant human hyaluronidase (rHuPH20); Recombinant hyaluronidase

Summary:

      The goal of this study is to determine if Hylenex recombinant leads to changes in the insulin
      time-action profiles and glucose responses when preadministered in the setting of continuous
      subcutaneous insulin infusion (CSII) compared to CSII without Hylenex recombinant (sham
      injection).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female participants between the ages 18 and 65 years, inclusive.

          2. Females of child-bearing potential must agree to use a standard and effective means of
             birth control for the duration of the study. Adequate contraceptive measures include
             oral or injectable contraceptives, sterilization, intra-uterine device (IUD), barrier
             methods, or abstinence.

          3. Participants with type 1 diabetes mellitus treated with insulin (multiple daily
             injections or continuous subcutaneous insulin infusion [CSII]) diagnosed ≥ 12 months
             prior to enrollment

          4. Body mass index (BMI) 18.0 to 32.0 kilograms per meters squared (kg/m^2)

          5. HbA1c (glycated hemoglobin A1c) ≤ 10% based on local laboratory results

          6. Fasting C-peptide < 0.6 nanograms per milliliter (ng/mL)

          7. Current treatment with insulin <1.2 Units per kg per day (U/kg/day)

          8. Participant should be in good general health based on medical history and physical
             examination, without medical conditions that might prevent the completion of study
             drug injections and assessments required in this protocol

        Exclusion Criteria:

          1. Inability to comply with study requirements as judged by the Investigator

          2. Known or suspected allergy to any component of any of the study drugs in this trial

          3. A participant who has proliferative retinopathy or maculopathy, severe gastroparesis,
             and/or severe neuropathy, in particular autonomic neuropathy, as judged by the
             Investigator

          4. As judged by the Investigator, clinically significant active disease of the
             gastrointestinal, cardiovascular (including a history of arrhythmia or conduction
             delays on electrocardiogram), hepatic, neurological, renal, genitourinary, or
             hematological systems

          5. As judged by the Investigator, uncontrolled hypertension (diastolic blood pressure ≥
             100 millimeters of mercury [mmHg] and/or systolic blood pressure ≥ 160 mmHg after 5
             minutes in the supine position)

          6. History of any illness or disease that in the opinion of the Investigator might
             confound the results of the trial 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. Anemia with hemoglobin less than lower limits of normal at screening is
             specifically exclusionary

          8. 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, or drugs not permitted according to Hylenex recombinant
             package insert

          9. Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the
             Investigator

         10. Current addiction to alcohol or substances of abuse as determined by the Investigator

         11. Blood donation (> 500 mL) within the previous 8 weeks (56 days) prior to Day -1 of
             Treatment Period 1

         12. Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate
             contraceptive measures (adequate contraceptive measures consist of sterilization, IUD,
             oral or injectable contraceptives, or barrier methods)

         13. Mental incapacity, unwillingness, or language barriers precluding adequate
             understanding or cooperation in this study

         14. Participation in any other clinical trial and receipt of any investigational drug
             within 4 weeks of Day -1 of Treatment Period 1

         15. Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will
             interfere with trial participation or evaluation of data

         16. Positive for human immunodeficiency virus (HIV), Hepatitis C or Hepatitis B

         17. Tobacco and nicotine use within 3 months prior to Day 1 of Treatment Period 1 or use
             during the study