A Study of LY2599506 (Oral Agent Medication: Glucokinase Activator 1) in Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2599506; Glyburide; Placebo
Intervention description: Administered orally (po), twice daily (BID) prior to morning and evening meals for 12 weeks; Administered po, BID daily prior to morning and evening meals for 12 weeks; Matching placebo capsules administered po, BID prior to morning and evening meals for 12 weeks
Intervention MeSH terms: Glyburide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to help answer the following research question(s):

        -  To test if taking LY2599506 for 12 weeks controls blood sugar better than taking
           glyburide for 12 weeks.

        -  To evaluate the safety of LY2599506 in participants with diabetes.

        -  To determine if LY2599506 has the ability to control blood sugar in participants with
           diabetes.

        -  To determine how much LY2599506 should be given to participants.

        -  To determine if LY2599506 has an effect on a participant's weight.

      The study design consists of 4 study periods: a screening period, a 4-week dose adjustment
      period, an 8-week treatment period, and a 4-week follow up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes mellitus prior to entering the trial

          -  Are currently being treated with diet and exercise therapy consistent with the local
             standards of medical care

          -  Treated with: Diet and exercise alone; or Diet and exercise in combination with a
             stable dose of metformin for at least 3 months prior to entering the trial; or Diet
             and exercise in combination with a stable dose of sulfonylurea for at least 3 months
             prior to entering the trial; or Diet and exercise in combination with stable doses of
             metformin and sulfonylurea for at least 3 months prior to entering the trial and have
             had diabetes for at least 6 years.

          -  Have an HbA1c value between 7% and 10%

          -  Are women not of child-bearing potential due to surgical sterilization (hysterectomy
             or bilateral oophorectomy or tubal ligation) or menopause. Male patients will be
             advised to use a reliable method of birth control during the study and until 3 months
             after the last dose of study medication if their partner is of child-bearing
             potential.

        Exclusion Criteria:

          -  Use of insulin or any antidiabetic agent other than metformin or sulfonylurea during
             the 3 months prior to entering the trial.

          -  Have a gastrointestinal disease that significantly impacts gastric emptying or
             motility (for example, severe gastroparesis or pyloric stenosis), in the opinion of
             the Investigator, or have undergone gastric bypass or gastric banding surgery.

          -  Have had more than 1 episode of severe hypoglycemia within 6 months prior to entry
             into the study, or are currently diagnosed as having hypoglycemia unawareness

          -  Have had 2 or more emergency room visits or hospitalizations due to poor glucose
             control in the past 6 months.

          -  Have cardiac autonomic neuropathy (for example, resting tachycardia or orthostatic
             hypotension), based on clinical signs, symptoms, or appropriate diagnostic testing.

          -  Have cardiac disease with functional status that is New York Heart Association Class
             II, III, or IV or a history of myocardial infarction, unstable angina, or
             decompensated congestive heart failure in the past 6 months.

          -  Have poorly controlled hypertension (that is, mean systolic blood pressure >160 mm Hg
             or mean diastolic blood pressure >100 mm Hg) history of malignant hypertension,
             evidence of renal artery stenosis, and/or evidence of labile blood pressure including
             symptomatic postural hypotension. Doses of antihypertensive medications must be stable
             for 30 days before randomization.

          -  Have fed or fasting state hypertriglyceridemia (defined as >6.8 millimoles per liter
             [mmol/L], 600 milligrams per deciliter [mg/dL]) at screening. If taking lipid-lowering
             agents, doses of these medications must be stable for 30 days prior to randomization.

          -  Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis,
             or repeated alanine transaminase (ALT) levels >2.5 times the upper limit of the
             reference range at screening.

          -  Have evidence of a significant active, uncontrolled endocrine or autoimmune
             abnormality, as judged by the Investigator at screening.

          -  Have an active or untreated malignancy or have been in remission from a clinically
             significant malignancy (other than basal or squamous cell skin cancer, in situ
             carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.

          -  Have a history of seizure disorder.