Differences in Endothelial Function Amongst Sitagliptin and Liraglutide Users

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide.

Differences in endothelial function amongst Sitagliptin and Liraglutide Users.

A randomized, open-label, parallel-group and active controlled trial.

It had two arms (groups): Liraglutide (experimental) and Sitagliptin (active comparator).

The registry classes the interventions as drug.

More on the Plan

The study will follow a parallel group, open-label design as liraglutide is administered by subcutaneous injection and sitagliptin orally in tablets.

The study objectives will be assessed after 3 months of therapy as it is considered a suitable timing for identifying short-term changes on flow-mediated vasodilation.

Who Took Part

The registry lists 13 actual participants took part.

It was open to people of any sex aged from 45 years up to 65 years.

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

Examples of who could join: Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.). Male or female patients between 45 and 65 years old. Systolic blood pressure (SBP) \<130 mmHg and diastolic blood pressure (DBP) \<85 mmHg or treatment with antihypertensive agents.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial product(s) or related products; previous participation in this trial. participation is defined as being randomised; previous type 2 diabetes treatment apart from metformin or insulin.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

The Liraglutide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.

It started in 2013-03 with completion listed for 2014-03.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Assess the effects on endothelial function of a three month treatment with Liraglutide compared to Sitagliptin (time frame: 3months).

It also tracked 1 secondary outcome, for example The evaluation of other emerging potential cardiovascular risk factors.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 13 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.