Safety and Efficacy of MCC-257 in the Treatment of Diabetic Polyneuropathy

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of the study are to evaluate the efficacy and safety of three doses of MCC-257 in patients with mild to moderate diabetic polyneuropathy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Criteria

Inclusion Criteria:

• The patient is male or female, 18-70 years of age

• The patient has either type 1 or type 2 diabetes

• The patient has mild to moderate diabetic neuropathy

• The patient is free from other clinically significant illness or disease, as determined by medical history, physical examination, laboratory evaluations, and other safety tests

Exclusion Criteria:

• Being treated with anticoagulants other than aspirin, such as warfarin, digoxin, Plavix

• BMI>40

• A significant disorder or a condition other than diabetes that can cause symptoms or physical conditions that mimic peripheral neuropathy or interfere with cognition

• Any proximal neuropathy, clinically evident nerve entrapment, or any focal trauma potentially affecting nerve function

• Women of childbearing potential who do not refrain from sexual activity or use adequate contraception

• Pregnant or lactating women

• An ALT or AST value >2X upper limit of normal (ULN)

• Clinically significant cardiovascular disease within the last six (6) months