A Study to Evaluate the Effect of LY2189265 on the Speed at Which Food and Drink Leaves the Stomach in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2189265; Placebo
Intervention description: 1.5 mg administered subcutaneously; Administered subcutaneously
Intervention MeSH terms: Dulaglutide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary purpose of this Study is to help answer the following research question(s).

        -  How does LY2189265 affect gastric emptying (the speed at which food and drink leaves the
           stomach) in patients with Type 2 diabetes?

        -  How does LY2189265 affect how the body handles metformin (a drug used to treat Type 2
           diabetes)?

        -  Is LY2189265 safe and are any side effects associated with it?

      The study will be participant-blind in Week 1, and participant- and investigator-blind from
      Week 2 through Week 5.

      Each participant will receive placebo on Week 1 and once-weekly doses of LY2189265 or Placebo
      on Weeks 2 to 5. Participants taking metformin for the treatment of Type 2 Diabetes Mellitus
      (T2DM) will continue taking metformin as part of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Are males or females, diagnosed with Type 2 Diabetes Mellitus for greater than or
             equal to 3 months prior to screening.

          2. Male patients agree to use a reliable method of birth control during the study and for
             3 months following the last dose of study drug. Female patients must be of
             non-child-bearing potential due to surgical sterilization or menopause.

          3. Have a body mass index (BMI) between 18.5 and 40.0 kilogram/square meter (kg/m²),
             inclusive.

          4. Have Type 2 Diabetes Mellitus controlled with diet and exercise alone or are stable on
             a single oral antidiabetic medication (e.g. metformin) prior to screening, and have
             been taking a stable dose for >7 days prior to the first dosing occasion.

          5. Have a fasting blood glucose value at screening >126 milligram/deciliter (mg/dL) (7.0
             [millimoles/liter] mmol/L) for patients on a controlled diet, and >108 mg/dL (6.0
             mmol/L) for patients on oral antidiabetic medication, with an upper limit of 180 mg/dL
             (approximately 9.9 mmol/L) in each case.

          6. Have a hemoglobin A1c (HbA1c) (indicates what your average blood glucose level has
             been in the past 3 months) value at screening (or within 4 weeks prior to screening)
             of 6.5% to 9.5%. If HbA1c is between 6.1% and 6.5%, patients may participate in the
             study providing they are receiving permissible oral antidiabetic medication.

          7. Have clinical laboratory test results within normal ranges as determined by the study
             doctor.

          8. Can provide enough blood in order to undergo the blood sampling required for the
             study.

          9. Are reliable and willing to make themselves available for the duration of the study
             and are willing to follow study procedures.

         10. Have signed the consent form approved by Lilly and the Ethical Review Board (ERB)
             governing the site.

             Exclusion Criteria:

         11. Are currently enrolled in, or discontinued within the last 30 days from, a clinical
             trial involving 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.

         12. Have previously been exposed to, or have known allergies to glucagon-like-peptide-1
             (GLP-1)-related compounds including LY2189265.

         13. Are persons who have previously completed or withdrawn from this study or any other
             study investigating LY2189265 or have received glucagon-like peptides or incretin
             mimetics in the past 3 months.

         14. Have taken certain Type 2 Diabetes medications within 30 days prior to screening.

         15. Have an abnormality in the electrocardiogram (ECG) performed at screening.

         16. Have poorly controlled high blood pressure (systolic blood pressure >160 millimeters
             of mercury [mmHg] and/or diastolic blood pressure >100 mmHg).

         17. Have a history or presence of respiratory, liver, kidney, hormonal, blood, or
             neurological disorders which may put the patient at risk when taking the study
             medication; or may interfere with the interpretation of data.

         18. Have a history or presence of cardiovascular disorder within the last year, or signs
             of congestive heart failure, or are expected to require coronary artery bypass surgery
             or angioplasty.

         19. Have a history or presence of pancreatitis or certain gastrointestinal disorders.

         20. Have been exposed to radiation from clinical trials and from diagnostic X-ray or are
             exposed routinely via your job worker.

         21. Have any non-removable metal objects such as metal plates, screws etc. in their chest
             or abdominal area.

         22. Have had acute diarrhea or constipation within 14 days of study screening.

         23. Show evidence of significant active neuropsychiatric disease.

         24. Regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening.

         25. Intend to start new medication during the study, including over-the-counter and herbal
             medication.

         26. Have donated blood of more than 500 milliliter (mL) within the last month prior to
             screening.

         27. Have an average weekly alcohol intake that exceeds the study centre's guidelines and
             are unwilling to adhere to the alcohol restrictions in place throughout the study.

         28. Smoke more than 10 cigarettes (or equivalent in nicotine) per day, and are unwilling
             to stop smoking on the day of medication administration or are unable to abide by
             clinical research unit (CRU) restrictions on other inpatient days.

         29. Are allergic to eggs or other components of the meals to be served.

         30. Are patients who, in the opinion of the investigator, are in any way unsuitable to
             participate in the study.