Status:
COMPLETED
Effect of C-Peptide on Diabetic Peripheral Neuropathy
Lead Sponsor:
Creative Peptides Sweden Inc.
Conditions:
Diabetes Mellitus, Type 1
Diabetic Polyneuropathy
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 hyp...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00278980
Start Date
October 1 2003
End Date
December 1 2004
Last Update
January 19 2006
Active Locations (1)
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1
Karolinska University Hospital Solna
Stockholm, Stockholm County, Sweden, SE-171 76