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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00278980

Enrollment

180

Registered

2006-01-19

Start date

2003-10-31

Completion date

2004-12-31

Last updated

2006-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1, Diabetic Polyneuropathy

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.

Interventions

DRUGC-peptide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Change in sensory nerve conduction velocity from baseline to 6 mo of treatment	—

Secondary

Measure	Time frame
- Change in quantitative sensory tests and	—
neurological impairment assessment from baseline to 6 mo of treatment	—
- Safety and tolerability of C-peptide	—

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026