Study of LY2409021 in Participants With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY2409021; Placebo; Glucagon
Intervention description: Administered orally; Administered orally; Administered via intramuscular injection
Intervention MeSH terms: Glucagon
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study involves taking a single dose of 100 milligrams (mg) or 300 mg LY2409021 or
      placebo (an inactive medicine) taken as up to 3 capsules by mouth. The study will evaluate if
      this drug will reduce the amount of insulin a type 1 diabetic needs over 24 hours. This study
      includes a 7-day hospitalization period at the clinical research unit (CRU) and will involve
      screening within 30 days of the start of the study as well as telephone consultations within
      5 days after discharge from the CRU.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had type 1 diabetes mellitus (T1DM) based on the World Health Organization
             classification for at least 1 year and have a daily insulin dose ≤1.5 international
             units (IU) per kilogram (kg) of body weight

          -  Have a glycated hemoglobin A1c (HbA1c) of no greater than 9.0% as measured at
             screening

          -  Have a body mass index (BMI) ≥19.0 and ≤35.0 kilograms per meter squared (kg/m^2)

          -  Have given written informed consent approved by Lilly

        Exclusion Criteria:

          -  Received any oral or injectable medication intended for the treatment of diabetes
             mellitus other than insulins in the 3 months prior to screening

          -  Have had more than 1 episode of severe hypoglycemia within 3 months prior to entry
             into the study, or are currently diagnosed as having hypoglycemia unawareness

          -  Are pregnant or intend to become pregnant during the course of the study

          -  Women who are breastfeeding

          -  Have a history of stroke, myocardial infarction, heart failure, unstable angina, or a
             coronary revascularization procedure within 6 months of screening

          -  Have fasting triglycerides >500 milligrams per deciliter (mg/dL) (5.65 millimoles per
             liter [mmol/L])

          -  Have obvious clinical signs, symptoms, or laboratory evidence of liver disease
             (alanine transaminase [ALT] or aspartate transaminase [AST] greater than 2 times the
             upper limit of normal at screening)

          -  Have a history of renal transplantation or are currently receiving renal dialysis or
             have a screening creatinine >2.0 mg/dL (177 micromoles per liter [μmol/L])

          -  Have had any other disease, illness, or condition (including known diabetic autonomic
             neuropathy, drug or alcohol abuse, or psychiatric disorder) within the 6 months prior
             to screening that precludes the participant from following and completing the study or
             could increase their risk for hypoglycemia, according to the investigator's judgment

          -  Are currently enrolled in, have completed, or have discontinued within the last 30
             days from a clinical trial involving an off-label use of an investigational drug or
             device, or are concurrently enrolled in any other type of medical research judged not
             to be scientifically or medically compatible with this study