NCT00278980

Effect of C-Peptide on Diabetic Peripheral Neuropathy

Effect of C-Peptide on Diabetic Peripheral Neuropathy, a 6 Months Randomized Double-Blind, Placebo Controlled, Dose-Finding, Multicenter Study, With Parallel Groups

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (planned)
• Sponsor: Creative Peptides Sweden Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1
• Diabetic Polyneuropathy

Interventions

Type	Name	Description
DRUG	C-peptide

Timeline

• Start date: 2003-10-01
• Completion: 2004-12-01
• First posted: 2006-01-19
• Last updated: 2006-01-19

Locations

1 site across 1 country: Sweden