A Study of Duloxetine (LY248686) in Participants With Diabetic Peripheral Neuropathic Pain (DPNP)
Condition: Diabetic Peripheral Neuropathic Pain
MeSH terms: Neuralgia; Diabetic Neuropathies
Intervention: Duloxetine; Pregabalin; Placebo
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Pregabalin; Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 304.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the effectiveness and safety of the study drug
      known as duloxetine in participants with diabetic peripheral neuropathic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants present with pain due to bilateral, peripheral neuropathy

          -  Participants who have hemoglobin A1c (HbA1c) ≤9.4% (National Glycohemoglobin
             Standardization Program [NGSP]) at screening

          -  Participants who have HbA1c that has been measured 42 to 70 days prior to screening,
             and the range of variation in the values measured, thereafter, is within ±1.0% of the
             value measured at screening

          -  Participants who have a score of at least 4 on the mean of the 24-hour average pain
             score measured using 11-point NRS (Numeric Rating Scale) in the daily diary (should be
             calculated from records 7 days immediately prior to randomization)

          -  Participants who have made complete daily diary entries 80% or more of the time from
             screening to randomization

        Exclusion Criteria:

          -  Participants who have undergone renal transplant, or are currently undergoing renal
             dialysis

          -  Participants who have uncontrolled narrow-angle glaucoma, history of uncontrolled
             seizures, or uncontrolled or poorly controlled hypertension

          -  Participants whose glycemic control has been poor within 70 days immediately prior to
             screening (for example, ketoacidosis requiring hospitalization, or hypoglycemia that
             may cause consciousness disorder)

          -  Pregnant or lactating female participants, or male participants who are planning for
             their partners to be or become pregnant during the timeframe of the study

          -  Participants who have hypersensitivity to multiple medications

          -  Participants who answered "yes" to either question 4 (active suicidal ideation with
             some intent to act, without specific plan) or question 5 (active suicidal ideation
             with specific plan and intent) on the "suicidal ideation" portion of the
             Columbia-Suicide Severity Rating Scale (C-SSRS) or answered "yes" to any of the
             suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt,
             preparatory act or behavior) on the "suicidal behavior" portion of the C-SSRS; and the
             ideation or behavior occurred within the past month

          -  Participants who have past history of psychiatric diseases, such as depression,
             anxiety disorder, eating disorder, etc., that required drug therapy in the past 1
             year, or who are currently having complications of these diseases or any history of
             manic psychosis or bipolar disorder

          -  Participants who have major depressive disorder as determined using the depression
             module of the Mini-International Neuropsychiatric Interview (MINI)

          -  Participants who have complications of diseases that are considered to affect the
             assessment of diabetic peripheral neuropathic pain. For example, nerve diseases with
             pain other than diabetic peripheral neuropathic pain (cervical spondylosis, carpal
             tunnel syndrome, spinal canal stenosis, and post-herpetic pain), pain diseases other
             than nerve diseases (collagen diseases, gout, chronic obstructive arteriosclerosis,
             and arthritis), and other pain at the site of evaluation (skin diseases and traumatic
             injury) are excluded

          -  Participants who have neuropathic pain suspected to be caused by alcohol

          -  Participants who have been treated with a monoamine oxidase (MAO) inhibitor(s) within
             14 days immediately prior to randomization. Participants who visited the investigator
             site 14 days prior to randomization, those who have been treated with MAO
             inhibitors(s), thereafter, are excluded

          -  Participants who have alanine aminotransferase (ALT) and aspartate aminotransferase
             (AST) at a level ≥100 units/liter at screening

          -  Participants who have total bilirubin at a level ≥1.5 milligrams/deciliter (mg/dL) at
             screening

          -  Participants who have creatinine clearance (CrCL), calculated by Cockcroft-Gault, that
             is <1.0 milliliters/second (mL/s) (<60 mL/minute) at screening

          -  Participants who have a white blood cell (WBC) value <2500/cubic millimeters (mm3),
             neutrophils <1500/mm3, or platelets <100×103/mm3 on their hematology tests at
             screening

          -  Participants who are introduced to any treatments for diabetes, or a change in dosing
             regimen of any treatments for diabetes (exclude insulin treatment), or resumption of
             insulin treatment after screening

          -  Participants who have been treated with prohibited concomitant drug(s), or who have
             undergone prohibited concomitant treatment(s) after screening

          -  Participants who have taken restricted concomitant drugs 27 days immediately before
             screening, with continued use of the restricted concomitant drug prior to screening

          -  Participants who have taken acetaminophen for 4 days or more 7 days immediately prior
             to randomization