Effect of C-Peptide on Diabetic Peripheral Neuropathy

What Was Tested

The trial (phase 2) is built around C-Peptide.

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.

The registry classes the interventions as drug.

More on the Plan

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 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.

Who Took Part

The registry lists 180 planned participants were the target.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: 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).

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got C-Peptide and who got the comparison, which limits bias.

The C-Peptide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on C-Peptide, so expectations could not easily colour the readings.

It started in 2003-10 with completion listed for 2004-12.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in sensory nerve conduction velocity from baseline to 6 mo of treatment.

It also tracked 3 secondary outcomes, for example - Change in quantitative sensory tests and, neurological impairment assessment from baseline to 6 mo of treatment and - Safety and tolerability of C-peptide.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of C-Peptide in 180 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the C-Peptide compound page, all human trials.