A 24-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Peripheral Neuropathy

This is a randomized outpatient, double‐blind, placebo‐controlled, multiple‐site study of the safety, tolerability, and exploratory efficacy of topically administered WST‐057 (4% pirenzepine free base monohydrate) for 24 weeks in subjects with T2DM with peripheral neuropathy. Subjects will attend visits at screening (day ‐45 to ‐28); day 1 (baseline); weeks 2, 4, 8, 12, 16, 20, 24; and follow‐up (week 26). Approximately 60 subjects with T2DM with peripheral neuropathy will be randomized to 1 of 4 treatment groups in a 1:1:4:4 ratio: placebo control 2 mL (n = 6 subjects), placebo control 4 mL (n = 6 subjects); low dose (2 mL) WST‐057 (73 mg pirenzepine free base monohydrate) (n = 24 subjects); and high dose (4 mL) WST‐057 (146 mg pirenzepine free base monohydrate) (n = 24 subjects), with the assumption that a total of 50 subjects will complete the study. This study is designed with 4 periods: screening, baseline/day 1, outpatient treatment, and safety follow‐up.