Effect of C-Peptide on Diabetic Peripheral Neuropathy

Creative Peptides Sweden Inc.180 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

180

Conditions

Diabetes Mellitus, Type 1 Diabetic Polyneuropathy

Interventions

C-peptideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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)

Locations (1)

Karolinska University Hospital Solna

Stockholm, Stockholm County, Sweden

Outcomes

Primary Outcomes

Change in sensory nerve conduction velocity from baseline to 6 mo of treatment

Secondary Outcomes

- Change in quantitative sensory tests and

neurological impairment assessment from baseline to 6 mo of treatment

- Safety and tolerability of C-peptide

Data from ClinicalTrials.gov

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