A Study To Compare the Effects of Insulin Peglispro and Glargine on Insulin Sensitivity and Meal Time Insulin Requirements in Type 2 Diabetics
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Intervention: Insulin Peglispro; Insulin Glargine; Insulin Lispro
Intervention description: Administered subcutaneously (SC), (U-100 formulation); Administered subcutaneously (SC), (U-100 formulation); Administered subcutaneously (SC), (U-100 formulation)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
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:

      This study will look into insulin sensitivity (how the body responds to insulin) and effects
      of meals on type 2 diabetics comparing insulin peglispro to insulin glargine. The study has
      two treatment periods, each of which will last about four weeks. One drug (insulin peglispro
      or insulin glargine) will be administered in each period. Participants will receive both
      drugs during the study. Participants may remain on stable dose metformin, as prescribed by
      their personal physician.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stable glycated hemoglobin (HbA1c) less than (<) 10.0 percent (%)

          -  Stable dose of either 0.2 to 1.5 units per kilogram per day (U/kg/day) basal insulin
             or a total daily insulin dose l<2.0 units per kilogram (U/kg)

          -  C-peptide <0.3 nanomole per liter (nmol/L)

          -  Stable body during the last 2 months

        Exclusion Criteria:

          -  Corrected QT interval (QTc) prolongation greater than (>) 500 milliseconds (ms) or
             have any other abnormality in the 12 lead

          -  Abnormal blood pressure

          -  A history or presence of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine (apart from Type 1 Diabetes Mellitus (T1DM)),
             hematological, or neurological disorders capable of significantly altering the
             absorption, metabolism, or elimination of drugs; of constituting a risk when taking
             the study medication; or of interfering with the interpretation of data

          -  Currently treated with oral antidiabetic drugs (OADs) (excluding metformin and
             dipeptidyl peptidase-4 (DPP4) inhibitors), or glucagon-like peptide-1 (GLP-1) agonists
             or intend to use over-the counter or prescription medication, herbal medications, or
             nutritional supplements that affect PG or insulin sensitivity, impact on hypoglycemic
             awareness or promote weight loss within 4 weeks prior to randomization

          -  Fasting triglycerides (TGs) >400 milligrams per deciliter (mg/dL) (4.52 millimoles per
             liter (mmol/L))

          -  Have used systemic or inhaled corticosteroids/glucocorticoid therapy (excluding
             topical, intra-articular, and intraocular preparations) within 4 weeks prior to
             randomization

          -  Currently receive insulin by pump or insulin degludec

          -  Poorly controlled diabetes or known to have poor awareness of hypoglycemia

          -  History of gastroparesis or gastrointestinal malabsorption

          -  Require treatment with any drug other than insulin to treat diabetes

          -  Previous history of proliferative retinopathy

          -  Excessive consumers of xanthines