Effect of Glucagon-like Peptide 1 (GLP-1) on Microvascular Myocardial Function in Patients With Type 2 Diabetes.

What Was Tested

This registered phase 4 trial tested Liraglutide.

It had two arms (groups): victoza (active comparator) and No treatment (no intervention).

The study is a cross over study. Patients randomised to start with victoza are treated with victoza for 10 weeks. After a wash out period of 2 weeks they cross over to 10 weeks of no treatment.

The registry classes the interventions as drug.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex aged from 25 years up to 75 years.

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

Examples of who could join: Type 2 diabetes on monotherapy with metformin or sulfonylurea or combination therapy of metformin and sulfonylurea. Age: 25-75 years.

The full record lists 4 inclusion and 15 exclusion criteria; among the exclusions: current treatment with insulin or dipeptidyl peptidase iv inhibitor; allergy towards victoza ® (liraglutide ), dipyridamol, nitroglycerin or rescue medicine: theophyllin; severe asthma.

How the Study Was Run

It was run as a randomized, crossover and single-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.

In the crossover set-up each of the participants took both Liraglutide and the comparison in turn, acting as their own control.

In this single-blind Liraglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2013-05 with completion listed for 2014-04.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in coronary flow reserve (CFR) (time frame: CFR is measured at baseline and after 10 weeks of intervention).

It also tracked 1 secondary outcome, for example Change in Endothelial function:.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 20 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.