Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin

What Was Tested

In this phase 3 trial, researchers set out to test Liraglutide.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 52 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: Type 2 diabetes.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: type 1 diabetes; symptoms of poorly controlled diabetes.

How the Study Was Run

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

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.

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

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

It started in 2012-08 with completion listed for 2015-11.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in A1c (time frame: Baseline to 24 wks).

It also tracked 12 secondary outcomes, for example Percentage of patients experiencing hypoglycemia, Change in Systolic Blood pressure, Change in diastolic blood pressure, Change in waist circumference, Change in body weight and Change in heart rate.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 52 people.

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.