GLP-1 and Non-exercise Activity Thermogenesis in RHZ

What Was Tested

This registered phase 4 trial tested Liraglutide.

It had two arms (groups): Liraglutide (placebo comparator) and Liraglutide and NEAT (active comparator).

Subjects will inject liraglutide once daily for 26 weeks.

The registry classes the interventions as behavioral and drug.

Who Took Part

22 actual participants took part.

It was open to people of any sex aged from 40 years up to 75 years.

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

Examples of who could join: Informed consent obtained before any study-related activities. Men or women with type 2 diabetes mellitus. BMI ≥ 25.0 kg/m2 at screening. Age between 40-75 years.

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: type 1 diabetes mellitus; use of glp-1 receptor agonist (exenatide, liraglutide or other) or pramlintide or any ddp-4 inhibitor within 3 months prior to screening; use of insulin within 3 months prior to screening.

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.

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 2012-10 with completion listed for 2013-11.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c from baseline and end of treatment (26 weeks) and end of follow-up (52 weeks) (time frame: 6 times, screening, week 0, week 13-26-39-52). Change in weight from baseline and end of treatment (26 weeks) and end of follow-up (52 weeks) (time frame: 6 times, screening, week 0, week 13-26-39-52).

It also tracked 4 secondary outcomes, for example Change in blood pressure from baseline and end of treatment (26 weeks) and end of follow-up (52 weeks), Change in quality of life from baseline and end of treatment (26 weeks) and end of follow-up (52 weeks), Change in NEAT from baseline and end of treatment (26 weeks) and end of follow-up (52 weeks) and Health-care related costs.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 22 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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