A Study of LY900014 in Japanese Participants With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro
Intervention description: Administered SC.; Administered SC.
Intervention MeSH terms: Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare LY900014, a drug that lowers blood sugar, with insulin lispro
      (Humalog). Both drugs will be given by injection under the skin of the abdomen. This study
      will be conducted in participants with type 1 diabetes to investigate how quickly and how
      much LY900014 is absorbed and the effect of LY900014 on blood sugar levels in comparison with
      insulin lispro. The study will last about 3 to 6 weeks for each participant, not including
      screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are Japanese male or female participant with a diagnosis of T1DM, based on the World
             Health Organization classification, for at least 1 year prior to screening

          -  Have a body mass index (BMI) of 18.5 to 30.0 kilograms per square meter (kg/m²)

          -  Have a glycated hemoglobin <9.0% at screening

        Exclusion Criteria:

          -  Have, except for current regimen of insulin therapy and concomitant medication(s),
             regular use of or intended use of any over-the-counter or prescription medications or
             nutritional supplements that treat hyperglycemia or insulin resistance or that promote
             weight loss within 14 days before dosing

          -  Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled
             glucocorticoid therapy (excluding topical, intra-articular, and intraocular
             preparations), or have received such therapy within the 4 weeks before screening

          -  Have a history of renal impairment (exclusion only if estimated glomerular filtration
             rate [GFR] <60 milliliters/minute/1.73 square meters [GFR is estimated according to a
             formula recommended by the Japanese Society of Nephrology]), or have a serum
             creatinine level ≥126 micromoles per liter (μmol/L) (>1.42 milligrams per deciliter
             [mg/dL]) (male) or ≥111 μmol/L (>1.25 mg/dL) (female)

          -  Have a history of deep vein thrombosis of the leg, or repeated episodes of deep leg
             vein thrombosis in first-degree relatives (parents, siblings, or children), as
             determined by the investigator

          -  Have proliferative retinopathy or maculopathy and/or severe neuropathy; in particular,
             autonomic neuropathy, as determined by the investigator based on a recent (<1.5 years)
             ophthalmologic examination

          -  Have had any significant changes in insulin regimen and/or unstable blood glucose
             control within the past 3 months prior to screening, as determined by the investigator

          -  Require daily insulin treatment >1.5 units per kilogram (U/kg)