The Effects of Physical Training and GLP-1 Receptor Agonist Liraglutide Treatment in Patients With Type 2 Diabetes

What Was Tested

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

The objective of this study is to investigate the effects of physical training in patients with type 2 diabetes during treatment with the GLP-1 receptor agonist liraglutide (Victoza®) in a 16-weeks double-blinded, randomized placebo-controlled clinical trial.

Hypothesis: Physical training leads to better metabolic control in type 2 diabetic patients when training is combined with liraglutide (Victoza®) treatment.

It had two arms (groups): Training and liraglutide (active comparator) and Training and placebo (placebo comparator).

Treatment with both training and liraglutide for 16 weeks.

Treatment wiht both training and placebo for 16 weeks.

The registry classes the interventions as other.

Who Took Part

The registry lists 40 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Informed oral and written consent. Diagnosed with type 2 diabetes according to the criteria of the WHO. Age \>18 years. BMI \>25 kg/m2 \<40 kg/m2. Negative islet cell antibodies (ICA) and glutamate decarboxylase 65 (GAD- 65) autoantibodies.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures; subjects treated with sulfonylureas, dipeptidyl peptidase 4 (dpp-4) inhibitors, insulin or glitazones; ongoing abuse of alcohol or narcotics.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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.

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2011-10 with completion listed for 2013-06.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c (time frame: 16 weeks).

It also tracked 6 secondary outcomes, for example Maximal oxygen uptake (VO2peak), Body weight, Blood pressure, Glycaemic control, Meal test and Myocardial echocardiography.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 40 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.