Diabetic Neuropathies Clinical Trial
Official title:
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Study to Evaluate the Efficacy and Safety of 3 Doses of TAK-583 in Subjects With Mild to Moderate Diabetic Peripheral Neuropathy
The purpose of this study is to determine the safety and effectiveness of TAK-583, once daily (QD), in the treatment of neuropathy caused by diabetes mellitus.
Diabetic polyneuropathy is a frequent complication in individuals with type 1 and 2 diabetes
mellitus, and can result in progressive functional and structural deficits in both somatic
and autonomic nerves. Diabetic polyneuropathy is characterized by degenerative changes in
nerve fibers resulting in progressive functional and structural deficits in both somatic and
autonomic nerves.
TAK-583 is a synthetic compound currently under development for the treatment of diabetic
polyneuropathy. The purpose of this study is to evaluate the safety and efficacy of TAK-583
for the treatment of mild to moderate diabetic polyneuropathy in subjects with type 1 or
type 2 diabetes mellitus. Study participation is anticipated to be about 8 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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