- Men and women aged 18 years to 80 years.
- Diagnosis of Type 2 diabetes mellitlus (T2DM) with current glycosylated hemoglobin
A1c (HbA1c) levels of ≤ 11% at Screening and on a stable antidiabetic medication
regimen for at least 30 days prior to randomization.
- Presence of ongoing pain due to DPN for at least 6 months.
- Willing to discontinue protocol-specified prohibited pain medications for DPN
throughout the duration of the study.
- Painful neuropathies or painful conditions other than DPN that may confound
evaluation of pain due to DPN during the study.
- Subjects who have failed previously on pregabalin (at the recommended label dose and
for adequate duration) due to lack of efficacy.
- Subjects with any clinically significant medical or psychiatric conditions or
clinically significant laboratory test abnormalities.
- Pregnant women, lactating mothers, men with partners currently pregnant, women
suspected of being pregnant, and women who wish to be pregnant during the course of
the clinical study.