A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain

Investigate the efficacy and safety of mirogabalin in Chinese participants with diabetic peripheral neuropathic pain in comparison to placebo.

The primary objective is to compare change from baseline in weekly Average Daily Pain Score (ADPS) at Week 14 in Chinese patients with Diabetic Peripheral Neuropathic Pain (DPNP) receiving mirogabalin versus placebo.

Inclusion Criteria:

• Type 1 or type 2 diabetes mellitus at screening
• Painful distal symmetric polyneuropathy, diagnosed at least 6 months prior to screening (see Procedures manual for the Diagnosis of Diabetic Peripheral Neuropathy and Neurological Examination for details)

Exclusion Criteria:

• HbA1c (National Glycohemoglobin Standardization Program) > 10.0% at screening
• Uncontrolled blood glucose within 1 month prior to screening, at screening or randomization
• Other severe pain at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP
• Neurologic disorders at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP
• Major psychiatric disorders at screening or randomization
• Creatinine clearance (using the Cockcroft-Gault equation) < 60 mL/min at screening