Effect of C-Peptide on Diabetic Peripheral Neuropathy

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to investigate the effect of C-peptide administration on nerve function in patients with type 1 diabetes and peripheral sensory neuropathy.

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

Details

• Lead Sponsor: Creative Peptides Sweden Inc.

Criteria

Inclusion Criteria:

• Subjects who have a duration of type 1 diabetes of more than 5 yrs

• Subjects who are C-peptide deficient

• Subjects who have diabetic distal symmetric neuropathy, according to the criteria defined at the San Antonio Conference on Diabetic Neuropathy 1988

• Subjects who have measurable action potential in the sural nerves

• Subjects who have reduced nerve conduction velocity in the sural nerves

Exclusion Criteria:

• Subjects who have neuropathy or signs of nerve dysfunction which may be a consequence of factors other than type 1 diabetes

• Subjects who have concomitant medication that may interfere with the peripheral nerve function or measurement thereof

• Subjects who are transplanted (islet cell, kidney or pancreas)