Title
Effect of C-Peptide on Diabetic Peripheral Neuropathy
Effect of C-Peptide on Diabetic Peripheral Neuropathy, a 6 Months Randomized Double-Blind, Placebo Controlled, Dose-Finding, Multicenter Study, With Parallel Groups
Phase
Phase 2Lead Sponsor
Creative Peptides Sweden Inc.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Diabetes Mellitus, Type 1 Diabetic PolyneuropathyIntervention/Treatment
c-peptide ...Study Participants
180The 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.
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.
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)
