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Effect of C-Peptide on Diabetic Peripheral Neuropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00278980
First Posted: January 19, 2006
Last Update Posted: January 19, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Creative Peptides Sweden Inc.
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00278980     History of Changes
Other Study ID Numbers: CPSp201
First Submitted: January 12, 2006
First Posted: January 19, 2006
Last Update Posted: January 19, 2006
Last Verified: January 2006

Additional relevant MeSH terms:
Diabetes Mellitus
Peripheral Nervous System Diseases
Diabetes Mellitus, Type 1
Polyneuropathies
Diabetic Neuropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases
Autoimmune Diseases
Immune System Diseases
Diabetes Complications