A Study for Treatment of Pain in Patients With Diabetic Neuropathy.
Condition: Diabetic Neuropathy, Painful
MeSH terms: Diabetic Neuropathies; Pain
Intervention: Placebo; Pregabalin; LY545694 21 mg; LY545694 49 mg; LY545694 105 mg
Intervention description: LY545694 placebo BID po for 5 weeks
Pregabalin placebo capsules TID po for 6 weeks; Pregabalin TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6
LY545694 placebo BID po for 5 weeks; LY545694 21 mg BID po for 1 week
Pregabalin placebo TID po for 6 weeks; LY545694 escalated to 49 mg BID po for 1 week during Week 2.
Pregabalin placebo TID po for 6 weeks.; LY545694 105 mg BID po for 5 weeks
Pregabalin placebo TID po for 6 weeks
Intervention MeSH terms: Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 273.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test whether a new treatment will be safe and effective in
      treating pain. Patients with diabetic peripheral neuropathy will be included.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have pain due to peripheral neuropathy based on disease diagnostic criteria: must have
             Type 1 or Type 2 diabetes mellitus, pain must being in the feet, with relatively
             symmetrical onset, daily pain must be present for at least 6 months, and diagnosis
             must be confirmed by a score of at least 3 on Part B of the Michigan Neuropathy
             Screening Instrument.

          -  Have stable glycemic control, and glycated hemoglobin (HbA1c) less than or equal to
             10%

          -  Mean score of at least 4 on the 24-hour average page severity assessment from (from
             daily diary) Visits 2 to 3.

          -  Fully completed daily diaries for at least 70% of the days between Visit 2 and 3.

          -  Women must test negative for a serum pregnancy test at Visit 1, and must agree to use
             medically acceptable and reliable means of birth control as determined by the
             investigator during the study and for 1 month following the last dose of study drug.

          -  Are competent and able to freely give own informed consent.

          -  Have an educational level and degree of understanding such that they can communicate
             intelligible with the investigator and study coordinator.

          -  Have been judged to be reliable and agree to keep all appointments for clinic visits,
             tests, and procedures required by the protocol.

        Exclusion Criteria:

          -  Have historical exposure to drugs known to cause neuropathy, or a history of a medical
             condition, including pernicious anemia and hypothyroidism, that could have been
             responsible for neuropathy.

          -  Have pain that cannot be clearly differentiated from or conditions that interfere with
             the assessment of diabetic neuropathy pain.

          -  Have had treatment with any centrally active neuroleptic drug within 30 days of visit
             3.

          -  Have had intolerance to pregabalin or have frequent and/or severe allergic reactions
             with multiple medications.

          -  Have current or previous (within the past 1 year) Axis 1 diagnosis of major depressive
             disorder, mania, bipolar disorder, psychosis, dysthymia, generalized anxiety disorder,
             alcohol or eating disorders according to Diagnostic and Statistical Manual of Mental
             Disorders 4th edition (DSM-IV) criteria, as determined by the investigator and
             confirmed by the Mini-International Neuropsychiatric Interview (MINI).

          -  Have a serious of unstable cardiovascular, hepatic, renal, respiratory,
             ophthalmologic, gastrointestinal, or hematologic illness, symptomatic peripheral
             vascular disease, or other medical condition that in the opinion of the investigator
             would compromise participation or be likely to lead to hospitalization during the
             course of the study.

          -  Have alanine aminotransaminase > 2 times upper limit of normal at Visit 1, based on
             reference ranges of central lab.

          -  Have prior renal transplant, current renal dialysis, or serum creatinine laboratory
             values > 1.5 times upper limit of normal, based on reference ranges of the central lab
             at Visit 1.

          -  Have a diagnosis or history of glaucoma.

          -  Are taking excluded medication that cannot be stopped and washed out prior to Visit 2.

          -  Have history of substance abuse or dependence within the past year, excluding nicotine
             and caffeine.

          -  Are judged clinically by the investigator to be at suicidal risk in the opinion of the
             investigator based upon clinical interview and the Columbia Suicide-Severity Rating
             Scale.

          -  Have a positive urine drug screen for any substance of abuse or excluded medication.

          -  Are unwilling or unable to comply with the use of a data collection device to directly
             record data from the subject (daily diary).

          -  Are pregnant or breast-feeding.

          -  Are investigator site personnel directly affiliated with this study and/or their
             immediate families.

          -  Are Lilly employees.

          -  Have received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of study entry.

          -  Have a history of recurrent seizures other than febrile seizures.

          -  Have a history of severe gastroparesis.