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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1; Diabetic Polyneuropathy
• Intervention / Treatment: Drug: C-peptide

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 Type: Interventional
• Enrollment: 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, SE-171 76
    • Karolinska University Hospital Solna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in sensory nerve conduction velocity from baseline to 6 mo of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Creative Peptides Sweden Inc.
• Investigators: Principal Investigator: Lisa Juntti-Berggren, MD, PhD, Karolinska University Hospital Solna, Stockholm, Sweden

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Study Completion: December 1, 2004

Study Registration Dates

• First Submitted: January 12, 2006
• First Submitted That Met QC Criteria: January 12, 2006
• First Posted (Estimate): January 19, 2006

Study Record Updates

• Last Update Posted (Estimate): January 19, 2006
• Last Update Submitted That Met QC Criteria: January 12, 2006
• Last Verified: January 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Diabetes Mellitus, Type 1; Peripheral Nervous System Diseases; Polyneuropathies; Diabetic Neuropathies
• Other Study ID Numbers: CPSp201