Efficacy and Safety Study of TAK-128 in Treating Subjects With Diabetic Peripheral Neuropathy
Condition: Diabetic Neuropathies
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of TAK-128, once daily
      (QD), in treating subjects with diabetic peripheral neuropathy.
    

Detailed description: 
      Polyneuropathy is a frequent complication of diabetes; it affects most individuals after
      prolonged hyperglycemia, and diabetic neuropathy is very common in the developed world.
      Chronic, insidious, distal sensorimotor polyneuropathy with autonomic impairment is the most
      typical form of diabetic neuropathy. Less common, but more florid presentations include
      autonomic symptoms or painful neuropathy. Although many patients have no or relatively few
      symptoms, the chronic polyneuropathy and autonomic dysfunction predispose to neurotrophic
      foot ulceration; consequently, diabetes is the leading cause of amputation today.

      Diabetic neuropathy is a dying-back polyneuropathy with distal degeneration of the longest
      nerve fibers advancing in a centripetal direction. Multiple histopathological changes are
      observed, but progressive fiber loss is the hallmark of diabetic polyneuropathy. Other
      important features include endothelial cell basement membrane thickening, segmental
      demyelination and remyelination, and axonal atrophy. Similar pathological changes are
      observed in type 1 and type 2 diabetes. The severity of neuropathy as indicated by the stage
      of nerve fiber loss determines the clinical, electrophysiological, and quantitative sensory
      threshold features of this disorder. The functional measures of electrophysiological and
      quantitative sensory thresholds reflect the morphological changes and the clinical features.

      Diabetic polyneuropathy is etiologically related to prolonged hyperglycemia with multiple
      consequences. Although strict glycemic control prevents neuropathy in type 1 patients if
      maintained for many years, similar interventions in those with type 2 diabetes mellitus are
      less successful. Type 2 patients may have neuropathy with considerable nerve fiber loss at
      the time of diagnosis because of unsuspected hyperglycemia in preceding years. Reversal of
      established neuropathy with strict glycemic control is not certain to occur, even if
      maintained for many years. Co-morbid disease often interferes with strict management of type
      2 diabetes. Even among those with type 1 diabetes, a minority of patients are successful in
      maintaining prolonged euglycemia.

      TAK-128 is a novel synthetic compound being developed as a treatment for diabetic neuropathy.
    

Intervention name(s): TAK-128; TAK-128; TAK-128; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): TAK-128 5 mg, tablets, orally, once daily for up to 6 months.; TAK-128 50 mg, tablets, orally, once daily for up to 6 months.; TAK-128 100 mg, tablets, orally, once daily for up to 6 months.; TAK-128 placebo-matching tablets, orally, once daily for up to 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetic Mononeuropathy; Diabetic Neuralgia; Mononeuropathy, Diabetic; Neuralgia, Diabetic; Diabetic Polyneuropathy; Drug Therapy