Impact of Liraglutide on Endothelial Function and Microvascular Blood Flow in Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 4) is built around Liraglutide.

It had two arms (groups): Metformin (no intervention) and Metformin and Liraglutide (experimental).

The registry classes the interventions as drug.

More on the Plan

In type 2 diabetic patients, an early marker in the biogenesis of atherosclerosis and cardiovascular disease is the occurrence of endothelial dysfunction with subsequent deterioration in micro- and macrovascular blood flow and tissue supply.

Also several mechanistic pathways linking Diabetes Mellitus with endothelial dysfunction and cardiovascular complications are postulated.

Future treatments in type 2 Diabetes Mellitus will be judged on their potency to affect the cardiovascular risk profile in patients with Diabetes Mellitus type 2.

In endothelial cells, isolated from human coronary arteries, GLP-1 rapidly activates endothelial nitric oxide synthase (eNOS) and stimulates nitric oxide (NO) production, promotes cell proliferation and inhibits glucolipoapoptosis.

Who Took Part

The registry lists 44 actual participants took part.

It was open to people of any sex aged from 30 years up to 65 years.

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

Examples of who could join: Diabetes Mellitus type 2. Age 30 - 65 years.

The full record lists 4 inclusion and 25 exclusion criteria; among the exclusions: pre-treatment with ppar gamma agonists or dpp iv inhibitors or glp-1 analogues within the last three months; history of type 1 diabetes mellitus; no full legal mental and physical ability to give informed consent.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2010-04 with completion listed for 2010-11.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Central vascular elasticity, Skin endothelial function and Skin oxygenation, Blood glucose control, Blood glucose control, Change of biomarker of heart failure and Insulin/ intact Proinsulin ratio, C-peptide.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 44 people.

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.