Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Humalog; Humulin-R; Recombinant human hyaluronidase PH20 (rHuPH20); Liquid meal
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Recombinant Hyaluronidase; Type 1 Diabetes Mellitus; Humalog; Humulin R; rHuPH20; Hylenex

Summary:

      Humalog and Humulin-R (recombinant human insulin) are Food and Drug Administration (FDA)
      approved medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase
      PH20 (rHuPH20) is approved by the FDA for use as an aid in the absorption and dispersion of
      other injectable drugs. In this study, rHuPH20 will be co-administered with both Humalog and
      Humulin-R in order to determine if it improves the absorption of these insulins to more
      closely mimic the body's natural increase in insulin in response to a meal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

          -  Participants with Type 1 diabetes mellitus treated with insulin for greater than or
             equal to 12 months.

          -  Body mass index (BMI) 18.0 to 29.0 kilograms per meter squared (kg/m^2), inclusive.

          -  Glycosylated hemoglobin A1c (HbA1c) less than or equal to 10% based on local
             laboratory results.

          -  Fasting C-peptide less than 0.6 nanograms per milliliter (ng/mL).

          -  Current treatment with insulin less than 1.2 units per kilogram per day (U/kg/day).

          -  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 injections and assessments required in this protocol.

        Exclusion Criteria:

          -  Known or suspected allergy to any component of any of the study drugs in this trial.

          -  Previous enrollment in this trial.

          -  A participant who has proliferative retinopathy or maculopathy, and/or severe
             neuropathy, in particular autonomic neuropathy, as judged by the Investigator.

          -  Clinically significant (as judged by the Investigator) active disease of the
             gastrointestinal, cardiovascular (including a history of arrhythmia or conduction
             delays on electrocardiogram [ECG]), hepatic, neurological, renal, genitourinary, or
             hematological systems, or uncontrolled hypertension (diastolic blood pressure greater
             than or equal to 100 millimeters of mercury [mmHg] and/or systolic blood pressure
             greater than or equal to 160 mmHg after 5 minutes in the supine position).

          -  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.

          -  Clinically significant findings (as judged by the Investigator) in routine laboratory
             data, including anemia with hemoglobin less than lower limits of normal at screening.

          -  Use of drugs which 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.

          -  Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the
             Investigator.

          -  Current addiction to alcohol or substances of abuse as determined by the Investigator.

          -  Blood donation (>500 milliliters [mL]) within the 9 weeks prior to first day of dosing
             on study.

          -  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).

          -  Mental incapacity, unwillingness, or language barriers precluding adequate
             understanding or cooperation.

          -  Symptomatic gastroparesis.

          -  History or evidence of use of any tobacco- or nicotine-containing product within 6
             months of screening or screening quantitative urine nicotine concentration >50 ng/mL.

          -  Receipt of any investigational drug within 4 weeks of first day of dosing in this
             study.

          -  Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will
             interfere with trial participation or evaluation of data.