Evaluation of the Impact of Training on Outcome Measures in Subjects With Painful Diabetic Neuropathy

Inclusion Criteria:

- Willingly signs and dates an Informed Consent Form (ICF) that is approved by an
Institutional Review Board/Independent Ethics Committee (IRB/IEC), prior to the
conduct of any study-specific procedures;

- Is at least 18 years old;

- Has a diagnosis of type 1 or type 2 diabetes and painful distal symmetric
sensorimotor polyneuropathy;

- Has experienced a minimum duration of PDN of at least 6 months;

- Is on stable diabetic medication that is not expected to change during the study;

- Has a worst pain intensity over the past 24 hours as a 4 or higher on a 0-10
numerical rating scale at Screening;

- And is able to read and communicate meaningfully in English and comply with all study
procedures

Exclusion Criteria:

- Has a psychiatric or psychological disorder that in the judgment of the Investigator
would interfere with the completion of the study, confound the study results, or pose
subject risk;

- Has an uncontrolled, clinically significant medical condition that in the judgment of
the Investigator may contraindicate use of pregabalin or participation in the study
(e.g., hepatic, respiratory, or hematologic illness; cardiovascular disease; or
symptomatic peripheral vascular disease);

- Has experience as an investigator or a study staff member in clinical trials research
in a role that involved direct patient contact;

- Participated in any of the following studies: Analgesic Solutions Protocol #
ALPMF.SOW.0007, Analgesic Solutions Protocol # ALPMF.SOW.0007.02, or Astellas
Protocol # E05-CL-3004;

- Has pain of other origin that might confound assessment of PDN;

- Has major skin ulceration;

- Has had an amputation other than toes;

- Has a history of suicide attempt within the past 1 year;

- Reports current suicidal ideation within the past 1month;

- Has history of kidney disease that is likely to decrease creatinine clearance;

- Has creatinine clearance below 60 as calculated by Cockroft-Gault equation for serum
creatinine;

- Has a history of drug or alcohol abuse within the past 1 year;

- Has hypersensitivity, intolerance, or allergy to pregabalin or gabapentin;

- Subject is pregnant, is considering becoming pregnant during the study, is
breastfeeding or unwilling to use adequate birth control during the study;

- Participated in another clinical trial within the past month;

- Is involved in an ongoing or settled worker's compensation claim, disability, or
litigation;

- Has a known failure to respond to pregabalin or gabapentin at a clinically relevant
dose due to either efficacy or tolerability;

- Or has taken opioids on an as-needed basis within 1week of Screening, or has taken
pregabalin or gabapentin within 30 days of screening. Subjects on stable doses
opioids, antidepressants, non-steroidal anti-inflammatory drugs, or low-dose aspirin
will be allowed to participate in the study