Effect of C-Peptide on Diabetic Peripheral Neuropathy

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00278980
• Other study ID #: CPSp201
• Status: Completed
• Phase: Phase 2
• First received: January 12, 2006
• Last updated: January 12, 2006
• Start date: October 2003
• Est. completion date: December 2004

Study information

• Verified date: January 2006
• Source: Creative Peptides Sweden Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Peripheral Nervous System Diseases
• Polyneuropathies

Intervention

Drug:
• C-peptide

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital Solna	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Creative Peptides Sweden Inc.

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sensory nerve conduction velocity from baseline to 6 mo of treatment
Secondary	- Change in quantitative sensory tests and
Secondary	neurological impairment assessment from baseline to 6 mo of treatment
Secondary	- Safety and tolerability of C-peptide