This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in patients with DPNP. To evaluate plasma Ctrough levels of XXX at 2 oral dose levels in patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic diabetic peripheral neuropathic pain (DPNP) over a 6-week period.
Adult male and female patients ≥18 to ≤75 years of age at the time of screening:
Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening.
Diagnosis of T1DM or T2DM with chronic DPNP.
Pain from DPN ranging between at least 6 months to no more than 5 years in duration.
At the Screening Visit, A1C must be ≤10.5% with no more than 1% absolute change in A1C (eg, 8% to 9%)in the previous 6 months.
Stable regimen for the treatment of T1DM or T2DM for ≥1 month prior to Screening, consisting of diet and/or oral or injectable antidiabetic therapy. Note: Modifications in insulin dose are permitted for patients using insulin.
Moderate to severe pain as confirmed by average pain score using scores recorded in the pain diary in the 14 days prior to randomization (Run-in Period).
Compensation is $64 for each completed visit. MRI and knee Xray will be required but no cost to the participant.