A Study for Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2409021; Placebo
Intervention description: 4 capsules by mouth taken once daily for 12 weeks; 4 capsules by mouth once daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 2

Summary:

      This drug is being evaluated for possible treatment of type 2 diabetes mellitus.
      Participation in this study is expected to last up to 18 weeks. A goal of this study is to
      determine the safety and effectiveness of LY2409021.
    

Eligibility criteria:

        Inclusion:

          -  Participants must either be male or a female who cannot become pregnant, who has type
             2 diabetes and is either controlling your diabetes through diet and exercise alone, or
             with diet and exercise taking metformin.

          -  If participants are male, participants are willing to talk to the study doctor about
             birth control options during the study and for 3 months after the last dose of study
             medication.

          -  Participants must have an Hemoglobin A1c (HbA1c) test of 6.5% to 10%

          -  Participants must have a body mass index (BMI) between 25 to 40 kilograms/square meter
             (kg/m²).

          -  Participants must be willing and able to test your blood sugar levels at home with a
             blood sugar meter.

          -  Participants must complete a study diary as instructed by your study doctor and staff
             and return the study diary as instructed by the study doctor.

          -  Participants must maintain consistent dietary, physical activity, and sleeping
             patterns throughout the study.

        Exclusion Criteria:

          -  Insulin, exenatide, or any diabetic medication other than metformin 3 months prior to
             screening to control you diabetes,

          -  Medications to increase movement in your digestive tract or that slow movement in your
             digestive tract

          -  Over-the-counter drugs or drugs prescribed by your doctor that cause weight loss or
             high or low blood sugar,

          -  Chronically use oral glucocorticoids therapy or have received this type of medication
             within 8 weeks prior to beginning this study,

          -  Class II and III antiarrhythmic agents (commonly used to prevent or relieve an
             irregular heartbeat),

          -  Drugs that damage the liver

          -  Fibrates and niacin (both commonly used to treat high cholesterol) more than 1
             gram/day (gm/day),

          -  Central nervous stimulants, alcohol intake for males that is more than 2 units per day
             and for females that is more than 1 unit per day [1 unit=12 ounces (oz) or 360
             milliliter (mL) of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled
             spirits].

          -  You have had one (1) or more cases of uncontrolled diabetes (very high blood sugars)
             which required hospitalization in the 6 months prior to the screening visit or have a
             diagnosis of hypoglycemia (low blood sugar) unawareness.

          -  You had two (2) or more emergency room visits or were hospitalized for poor control of
             your diabetes (for example, keto-acidotic episode) in the last 6 months.

          -  Participants have a problem with your stomach such that it empties slowly (diabetic
             gastroparesis) or you have had gastric bypass (bariatric) surgery.

          -  Participants have a personal or family history of pancreatic neoplasia.

          -  Participants have abnormal lipids (for example triglycerides).

          -  Participants have had problems with your heart in the past 6 months, such as a heart
             attack, chest pain (angina), heart failure, heart bypass operation, angioplasty (a
             medical procedure to open a narrow or clogged blood vessel of the heart) or stent
             insertion (a procedure to insert a wire mesh tube to prop open a blood vessel after
             angioplasty), a heart rhythm problem, or a stroke.

          -  Participants have an elevated or uncontrolled blood pressure.

          -  Participant's electrocardiogram (ECG, a test that measures the electrical activity of
             your heart) is outside the normal limits, as determined by the study doctor.

          -  Participants have a problem with your kidneys or are on dialysis.

          -  Participants have a problem with your pancreas.

          -  Participants must not have nor had liver disease (for example, Hepatitis B or C).

          -  Participants have cancer, except for skin cancer or have been in remission (the
             absence of disease activity) from cancer for less than 5 years.

          -  Participants have a serious or uncontrolled health problems (other than type 2
             diabetes), blood disorders or laboratory tests that in the opinion of the doctor,
             could interfere with understanding the results of this study. The doctor will let you
             know if this applies to you.

          -  Participants previously completed or withdrew from this study or any other study
             investigating LY2409021.

          -  Participants are allergic to the study drug or other related drugs. You cannot be in
             this study if you are a woman and you possibly could become pregnant during this
             study.