The Lira Pump Trial

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Liraglutide.

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

The registry classes the interventions as drug.

Who Took Part

44 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: BMI \> 25 kg/m2. Insulin pump ≥ 1 year. Use of carbohydrate counting and the insulin pump bolus calculator.

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: liver disease with alat \> 2.5 times the upper limit of the reference interval; acute or chronic pancreatitis or history of chronic pancreatitis or idiopathic acute pancreatitis; inflammatory bowel disease.

How the Study Was Run

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

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2015-02 with completion listed for 2016-10.

It ran at 2 sites in Denmark (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (time frame: 6 months).

It also tracked 12 secondary outcomes, for example Change in weight, Change in insulin pump settings, Change in glucose variability as measured by continuous glucose monitoring, Change in body composition as measured by DXA-scan, Change in blood pressure and Change in lipid profile (LDL, HDL, VLDL, total cholesterol, triglycerides).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Liraglutide in 44 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.