A Study of LY2922083 in Healthy Participants and Participants With Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; LY2922083
Intervention description: Administered orally as capsules; Administered orally as capsules
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 36.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The aim of this trial is to evaluate the safety of the study drug in healthy participants and
      participants with diabetes. It will investigate how much of the study drug gets into the
      blood stream and how long it takes the body to get rid of it. Information about any side
      effects that may occur will also be collected.

      The study consists of two parts. Part A will study healthy participants in up to 3 dosing
      periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3
      dosing periods over approximately 6 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

        For all participants :

          -  Must be a male, or a female who cannot become pregnant, and who is either a healthy
             participant, or who has type 2 diabetes

          -  Have a screening body mass index (BMI) of at least 18.0 kilograms per square meter
             (kg/m^2)

          -  Have blood pressure, pulse rate, blood and urine laboratory test results acceptable
             for the study

        For participants with T2DM:

          -  Do not have any change to their diabetes treatment (exercise with or without
             metformin) for at least 4 weeks prior to screening

          -  Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6% and less than
             or equal to 11% at screening

        Exclusion Criteria:

        For all participants :

          -  Are currently participating in another clinical study or completed one in the last 30
             days

          -  Are allergic to LY2922083 or other related drugs

          -  Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or
             have any medical problems which may cause an increased risk during the study

          -  Have electrocardiogram (ECG) readings that are not suitable for the study

          -  Have a history of hepatitis or jaundice

          -  Are infected with hepatitis B

          -  Are infected with hepatitis C

          -  Are infected with human immunodeficiency virus (HIV)

          -  Have donated more than 450 milliliters (mL) of blood in the last 3 months or have
             donated any blood in the last month

          -  Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week
             (female), or are unwilling to stop alcohol as required by the study restrictions (1
             unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)

          -  Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while
             at the clinic

        For participants with T2DM :

          -  Have had heart disease or stroke within 6 months before entering the study

          -  Have health complications due to poorly controlled diabetes as shown by blood and
             urine laboratory test results or based on physical examination and medical assessment
             as determined by the study doctor

          -  Have been hospitalized for poor control of diabetes (keto-acidotic episode) in the
             last 6 months

          -  Have used insulin to control diabetes in the last 1 year

          -  Show symptoms of high blood sugar (for example, frequent urination, always feeling
             thirsty, or unexpected weight loss)