NCT00760955

Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral Neuropathy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 338 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetic Neuropathies

Interventions

Type	Name	Description
DRUG	TAK-583	TAK-583 5 mg, tablets, orally, once daily for up to 6 months.
DRUG	TAK-583	TAK-583 50 mg, tablets, orally, once daily for up to 6 months.
DRUG	TAK-583	TAK-583 100 mg, tablets, orally, once daily for up to 6 months.
DRUG	Placebo	TAK-583 placebo-matching tablets, orally, once daily for up to 6 months.

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2008-09-26
• Last updated: 2016-06-22

Locations

38 sites across 2 countries: United States, Canada