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Effect of C-Peptide on Diabetic Peripheral Neuropathy

This study has been completed.
Sponsor:
Information provided by:
Creative Peptides Sweden Inc.
ClinicalTrials.gov Identifier:
NCT00278980
First received: January 12, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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

No publications provided

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

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

ClinicalTrials.gov processed this record on May 23, 2013