The Effects of Liraglutide on Sudomotor Function and Inflammation in Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Liraglutide.

It had two arms (groups): Placebo (placebo comparator) and one (experimental).

The registry classes the interventions as drug and other.

More on the Plan

The investigators propose to examine the effects of GLP-1 receptor agonist Liraglutide on autonomic sudomotor function and endothelial and neurovascular functions as well as markers of inflammation in patients with type 2 diabetes mellitus (T2DM).

The primary objective will be changes in peripheral autonomic function using sudorimetry (Sudoscan) after 1 year of treatment.

The aim of this study is to capture patients early in the disease process, when autonomic dysfunction is still potentially reversible.

Who Took Part

44 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Established type 2 diabetes (diabetes duration of \>6 months and \<10 years). Age 18-80 years.

The full record lists 4 inclusion and 30 exclusion criteria; among the exclusions: presence of type 1 diabetes mellitus (defined as c-peptide \<1 ng /ml, \<35y and prone to ketoacidosis); treatment with rapid-acting or short-acting insulin within the last 3 months; proliferative retinopathy or maculopathy requiring acute treatment.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2016-05 with completion listed for 2020-04.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Sudomotor Function (time frame: One Year).

It also tracked 4 secondary outcomes, for example Inflammatory Markers C-Reactive Protein (CRP), Inflammatory Markers IL-1β, Inflammatory Markers IL6 and Inflammatory Markers Tumor Necrosis factor α (TNF α).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 44 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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