A Long-term Trial to Compare the Effects of Liraglutide and Sulphonylurea (Glimepiride) Both in Combination With Metformin on Clinical, Endothelial and Image Markers of Cardiovascular Risk in Patients With Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Liraglutide.

The process of atherosclerosis is multifactorial and involves many mechanisms.

The majority of published works have identified endothelial dysfunction as the first step in a cascade of events that culminates in plaque formation.

Among the various mechanisms that occur following the attack on the vessel wall, it is thought that stem cells in the form of endothelial progenitor cells (EPCs) are the endothelial protection mechanism.

It had two arms (groups): Liraglutide + metformin (experimental) and glimepiride + metformin (active comparator).

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Informed written consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject). Male or female patients between 18 and 75 years old;. Subjects diagnosed with type 2 diabetes for more than 1 year. Adherence to injection therapy.

The full record lists 7 inclusion and 17 exclusion criteria; among the exclusions: type 1 diabetic patients;; use of a glp-1 receptor agonist (exenatide, liraglutide or other), pramlintide, thiazolidinediones or any dpp-4 inhibitor within the 3 months prior to screening;; patients with a clinical history of serious cardiovascular events in the last 3 months (myocardial infarction, unstable angina, cerebral infarction, tia, peripheral arteriopathic event);.

How the Study Was Run

Design: 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.

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

It started in 2012-05 with completion listed for 2013-12.

It ran at 1 site in Spain.

What Was Measured

Primary outcome: assess the effect of treatment with liraglutide compared to glimepiride, as add-on to metformin, for one year on circulating levels of EPCs in patients with type 2 diabetes poorly controlled (time frame: 1 year).

It also tracked 3 secondary outcomes, for example Relationship between EPC levels and all these biomarkers in patients treated with liraglutide compared to those treated with glimepiride and Safety parameters of glycaemic control: HbA1c, FPG.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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