A Study of LY2409021 on Blood Pressure and Pulse Rate in Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2409021; Placebo; Metformin
Intervention description: Administered orally; Administered orally; Administered as background therapy.
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of the trial is to determine the effect of a study drug known as LY2409021
      on blood pressure and pulse rate in participants with type 2 diabetes mellitus (T2DM) when
      compared to placebo. The study has two periods. Each participant will receive LY2409021 or
      placebo in each period. At least 4 weeks will pass between periods. The study will last about
      23 weeks for each participant. Participants may remain on stable dose metformin, as
      prescribed by their personal physician.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes mellitus (according to the World Health Organization diagnostic
             criteria) and use diet and exercise alone or in combination with a stable dose of
             metformin ( >/=1000 mg/day [or <1000 mg, if documented intolerance to 1000 mg or
             higher dosages] immediate-release metformin or extended-release metformin for at least
             2 months before screening).

          -  Have glycated hemoglobin (HbA1c) values >/=6.5% and </=8.5%, as determined by the
             central laboratory at screening.

          -  Have mean blood pressures >90/60 millimeters of mercury (mm Hg) and <140/90 mm Hg at
             screening.

          -  If being treated for hypertension, are taking 3 or fewer antihypertensive medications
             and have been taking stable doses of the same medications for at least 1 month before
             screening.

          -  Stable body weights (±5%) for >/=3 months before screening.

          -  Body mass indexes >/=20 kilograms/meters squared (kg/m²) and <40 kg/m².

          -  In the investigator's opinion, are well motivated, capable, and willing to:

               -  Reliably administer the oral study drug once daily;

               -  Maintain a study diary;

               -  Perform self-monitored blood glucose testing; and

               -  Wear an ambulatory blood pressure monitoring device for at least 24 hours (on
                  multiple occasions).

          -  Are women not of child-bearing potential due to:

               -  Surgical sterilization, hysterectomy, or bilateral oophorectomy (at least 6 weeks
                  postsurgery) or tubal ligation (confirmed by medical history); or

               -  Menopause. Women with an intact uterus are deemed menopausal if they have a
                  cessation of menses for at least 1 year with follicle stimulating hormone >40
                  milli-international units per milliliter (mIU/mL), are not taking hormones or
                  oral contraceptives within 1 year, and are otherwise healthy.

          -  Males who are sexually active and/or have partners of child-bearing age must use
             reliable methods of birth control during the study and until 3 months after the last
             doses of study medication. These requirements do not apply if a participant or his
             partner has been surgically sterilized or is not between menarche and 1 year
             postmenopausal.

        Exclusion Criteria:

          -  Have severe gastrointestinal disease that may significantly affect gastric emptying or
             motility.

          -  Previous histories or active diagnoses of pancreatitis.

          -  Acute or chronic hepatitis, signs or symptoms of any other liver disease, or alanine
             aminotransferase (ALT) level greater than 2.5 times the upper limit of normal (ULN).

          -  Elevated total bilirubin (greater than 2 times ULN), clinically suspicious signs or
             symptoms of cirrhosis or history of cirrhosis.

          -  Mean resting pulse rate (PR) less than 60 beats per minute (bpm) or greater than 100
             bpm.

          -  Current diagnosis or personal history of neuroendocrine tumors, family history of any
             type of multiple endocrine neoplasia, or Von Hippel-Lindau disease.