GLP-1 and Microvascular Function in Type 2 Diabetes

What Was Tested

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

Some gut hormones, called incretins, stimulate insulin production in order to control sugar levels but also activate brain centres and signal to stop eating.

Current administration of incretin-based therapies mimicking these gut hormones is by subcutaneous (just under the skin) injection and has been routinely available for diabetic patients for more than 4 years.

It had three arms (groups): Liraglutide (active comparator), diet (placebo comparator) and Aspirin (placebo comparator).

Liraglutide (Victoza) daily injections.

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 39 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

The full record lists 1 inclusion and 16 exclusion criteria; among the exclusions: use of insulin; contraceptives, tamoxifen; DPP-IV inhibitors.

How the Study Was Run

It was run as a randomized, parallel-group and open-label 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.

Being open-label, the Liraglutide study did not mask who received what.

It started in 2011-01 with completion listed for 2015-12.

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: change of baseline skin maximum hyperaemia at 4 months (time frame: baseline and 4 months).

It also tracked 3 secondary outcomes, for example change of baseline peripheral arterial tone at 4 months, change of baseline endothelial-dependent vasodilation at 4 months and change of baseline capillary density at 4 months.

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.