Back to resultsEffect of C-Peptide on Diabetic Peripheral Neuropathy
Primary Purpose
Diabetes Mellitus, Type 1, Diabetic Polyneuropathy
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
C-peptide
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility 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)
Sites / Locations
- Karolinska University Hospital Solna
Outcomes
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
Full Information
NCT ID
NCT00278980
First Posted
January 12, 2006
Last Updated
January 12, 2006
Sponsor
Creative Peptides Sweden Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00278980
Brief Title
Effect of C-Peptide on Diabetic Peripheral Neuropathy
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Creative Peptides Sweden Inc.
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetic Polyneuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
C-peptide
Primary Outcome Measure Information:
Title
Change in sensory nerve conduction velocity from baseline to 6 mo of treatment
Secondary Outcome Measure Information:
Title
- Change in quantitative sensory tests and
Title
neurological impairment assessment from baseline to 6 mo of treatment
Title
- Safety and tolerability of C-peptide
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Juntti-Berggren, MD, PhD
Organizational Affiliation
Karolinska University Hospital Solna, Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital Solna
City
Stockholm
ZIP/Postal Code
SE-171 76
Country
Sweden
12. IPD Sharing Statement
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Effect of C-Peptide on Diabetic Peripheral Neuropathy
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