A Study of LY2605541 (Insulin Peglispro) and Human Insulin Concentrations in Fat Tissue
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Insulin Peglispro; Human Insulin
Intervention description: Administered IV; Administered IV
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus.
      This study is designed to understand how the body handles the investigational drug, and to
      measure the quantity of LY2605541 in fat tissue. The study has two parts. It involves
      intravenous (IV) infusion of the investigational drug and a procedure to measure
      concentrations in the fat tissue. Both parts of the study will be conducted in participants
      with type 1 diabetes mellitus (T1DM). Part A and B of the study might take up to 7 weeks to
      complete.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) based on medical history for at
             least 1 year prior to enrollment

          -  Have a c-peptide value ≤0.3 nanomoles per liter (nmol/L) at screening

          -  Have a serum creatinine value within normal limits at screening

          -  Have a haemoglobin A1c (HbA1c) value ≤75 millimoles per mole (mmol/mol) (9.0%) at
             screening

          -  Have a body mass index (BMI) of 20.0-30.0 kilograms per meter squared (kg/m^2),
             inclusive, at screening

        Exclusion Criteria:

          -  Have known or suspected allergies or hypersensitivities to LY2605541, human insulin,
             sinistrin, related compounds or any components of the formulations

          -  Are women who are pregnant or lactating

          -  Have an abnormal blood pressure for the population as determined by the investigator

          -  Have renal insufficiency or major renal disorders

          -  Have proliferative retinopathy or maculopathy

          -  Have lipodystrophy

          -  Have any wound healing disorder or are prone to keloid or hypertrophic scar formation

          -  Have results of screening prothrombin time (PT) and international normalized ratio
             (INR) tests that are significantly prolonged

          -  Have a fasting triglycerides value > 4.52 millimoles per liter (mmol/L) (400
             milligrams/deciliter (mg/dL))

          -  Are receiving chronic systemic or inhaled glucocorticoid or have received such therapy
             within the 4 weeks before dosing

          -  Have a total daily insulin dose greater than 1.2 units per kilogram (U/kg)

          -  Regular use or intended use of any over-the-counter or prescription medications or
             nutritional supplements that affect blood glucose or the body's sensitivity to insulin
             or that promote weight loss within 14 days prior to dosing

          -  Regular use or intended use of non-selective beta blockers

          -  Regular use or intended use of monoamine oxidase (MAO) inhibitors

          -  Are currently participating in a weight loss program or plan to do so during the
             course of the study

          -  Are unwilling to avoid excessive sun exposure, steam baths, saunas, and swimming
             during the study. Sun cream should be used during sun bathing for the 6-month period
             following the study

          -  Are unwilling to avoid extensive consumption of food containing inulin during the
             study and in the 48-hour period leading up to the clamp