Treatment of Diabetic Neuropathy With Liraglutide

What Was Tested

In this not phased trial, researchers set out to test Liraglutide.

The purpose of this trial is to explore whether liraglutide has a long term effect on clinical symptoms and biomarkers in patients with diabetic neuropathy.

It had two arms (groups): Placebo treatment (placebo comparator) and Liraglutide treatment (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 39 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Abile person of Northern European descent. Age between 18 to 65 years. The participants must be able to read and understand Danish. Peripheral diabetic neuropathy ensured by having abnormal nerve conduction velocity. BMI equal to or above 22.

The full record lists 9 inclusion and 16 exclusion criteria; among the exclusions: diabetes mellitus type ii; calcitonin \> 25; patients on glp-1 receptor agonist treatment (exenatide, liraglutide or others) or pramlintide or any dpp-4 inhibitor within 3 months prior to screening.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2014-05 with completion listed for 2017-02.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: RIII withdrawal reflex activity (using standard electromyography) (time frame: After 6 months of treatment with Liraglutide). Evoked brain potentials (using standard electroencephalographic brain imaging) (time frame: After 6 months of treatment with Liraglutide).

It also tracked 11 secondary outcomes, for example Heart rate variability/ alterations in simpatico-vagal balance (24 h Holter monitoring), Resting brain activity (spectral analysis of resting brain activity), Microstructural brain neurodegeneration (assessed by diffuse tensor imaging), Variety in day/night blood pressure, Gut transit assessed by SmartPill (pH, pressure and transit in stomach, small and large intestine) and Quantitive sensory testing of pressure algometry in muscle.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 39 people.

Its size is small, so on its own it can only give an early look.

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

More context: the Liraglutide compound page, all human trials.