Effect of C-Peptide on Diabetic Peripheral Neuropathy - Full Text View

Sponsored by:	Creative Peptides Sweden Inc.
Information provided by:	Creative Peptides Sweden Inc.
ClinicalTrials.gov Identifier:	NCT00278980

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1 Diabetic Polyneuropathy	Drug: C-peptide	Phase II

MedlinePlus related topics: Diabetes Diabetes Type 1 Peripheral Nerve Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Creative Peptides Sweden Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	180
Study Start Date:	October 2003
Estimated Study Completion Date:	December 2004

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278980

Locations

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

Sponsors and Collaborators

Creative Peptides Sweden Inc.

Investigators

Principal Investigator:

Lisa Juntti-Berggren, MD, PhD

Karolinska University Hospital Solna, Stockholm, Sweden

More Information

Study ID Numbers:	CPSp201
Study First Received:	January 12, 2006
Last Updated:	January 12, 2006
ClinicalTrials.gov Identifier:	NCT00278980
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Metabolic Diseases
Autoimmune Diseases
Diabetic Neuropathies
Polyneuropathies
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms

Diabetes Mellitus, Type 1
Neuromuscular Diseases
Peripheral Nervous System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Diabetes Complications

Additional relevant MeSH terms:

Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009