Effect of C-Peptide on Diabetic Peripheral Neuropathy

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetic Polyneuropathy

• Registration Number: NCT00278980
• Lead Sponsor: Creative Peptides Sweden Inc.

Brief 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.

Detailed Description

It has been observed that C-peptide administration results in an activation of renal tubular and sciatic endoneural Na/K-ATPase of the rat and stimulation of endothelial nitric oxide synthase. The hypothesis is that C-peptide administration may improve peripheral nerve dysfunction in diabetic neuropathy by increasing nerve blood flow and Na/K-ATPase activity. The purpose of the trial is to investigate the effect of C-peptide administration on diabetic peripheral sensory neuropathy in patients with type 1 diabetes and diabetic neuropathy in the lower extremities.

Study Timeline

• Study Start: 2003-10
• Study Completion: 2004-12
• Status Verified: 2006-01
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Last Update Submitted: 2006-01-12
• Study First Posted: 2006-01-19
• Last Update Posted: 2006-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in sensory nerve conduction velocity from baseline to 6 mo of treatment

Secondary Outcome Measures

Name	Time	Method
- Change in quantitative sensory tests and
neurological impairment assessment from baseline to 6 mo of treatment
- Safety and tolerability of C-peptide

Trial Locations

Locations (1)

Karolinska University Hospital Solna; 🇸🇪 Stockholm, Sweden