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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
338
Change from Baseline for a composite measure of Maximal Nerve Conduction Velocity of the Peroneal and Median Motor Nerves and the Median and Sural Sensory Nerves.
Time frame: Month 6 or Final Visit
Change from Baseline in Electrophysiological Parameters for Individual Nerves.
Time frame: Month 6 or Final Visit
Change from Baseline in Sensory Sub-Composite and Motor Sub-Composite Scores.
Time frame: Months 3 and 6 or Final Visit
Change in Vibration Perception Threshold.
Time frame: Months 3 and 6 or Final Visit
Change in Pain Scores.
Time frame: Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change in Neurological Examination Score.
Time frame: Months 3 and 6 or Final Visit
Change in Quality of Life Index Score.
Time frame: Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change in glycosylated hemoglobin.
Time frame: Months 3 and 6 or Final Visit
Change in fasting plasma glucose.
Time frame: Months 3 and 6 or Final Visit
Change in fasting insulin.
Time frame: Months 3 and 6 or Final Visit
Change in Fasting C-peptide.
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TAK-583 placebo-matching tablets, orally, once daily for up to 6 months.
Unnamed facility
Mesa, Arizona, United States
Unnamed facility
Peoria, Arizona, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Jonesboro, Arkansas, United States
Unnamed facility
Huntington Beach, California, United States
Unnamed facility
La Jolla, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Pasadena, California, United States
Unnamed facility
Tustin, California, United States
...and 28 more locations
Time frame: Months 3 and 6 or Final Visit