Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy

An Asian, Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Pregabalin-controlled, Dose-finding Study of DS-5565 in Patients With Pain Associated With Diabetic Peripheral Neuropathy

The purpose of this study is to investigate the effectiveness and safety of DS-5565, compared to placebo, in subjects with pain associated with diabetic peripheral neuropathy.

Inclusion Criteria:

• Type 1 or Type 2 diabetes mellitus
• Painful distal symmetric polyneuropathy
• Average daily pain score is great than or equal to 4

Exclusion Criteria:

• HbA1c greater than 9.0