Liraglutide in Type 1 Diabetes

What Was Tested

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

It had two arms (groups): Liraglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The study was not placebo controlled.

Insulin pump therapy is however only an option in very compliant patients.

Carotis intima media thickness is a validated estimate for future cardiovascular disease and pulse wave velocity is a measure of arterial stiffness.

The researchers perform 24 hour blood pressure measurements to document possible effects of liraglutide on blood pressure and CIMT and PWV to investigate the effect of liraglutide on cardiovascular disease and arteriosclerosis.

Who Took Part

Enrollment: 100 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Age ≥ 18 years. BMI \> 25 kg/m2.

The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: insulin pump treatment; hypoglycaemia unawareness (unability to register low blood glucose); diabetic gastroparesis.

How the Study Was Run

It was run as a randomized, single-group and triple-blind study.

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

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

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

It started in 2012-06 with completion listed for 2015-02.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c (time frame: 24 week).

It also tracked 5 secondary outcomes, for example Body weight, Cardiovascular, Standardised liquid meal test, Glycaemic excursions and Quality of life.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 100 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.