Antiproteinuric Effects of Liraglutide Treatment

What Was Tested

This registered phase 4 trial tested Liraglutide.

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

Placebo s.c. for 12 weeks.

The registry classes the interventions as drug.

More on the Plan

In addition, possible mechanisms causing the antiproteinuric effect will be explored.

Who Took Part

32 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: Must give written informed consent before participation. Patient information and consent form must be approved by the Danish Medicines Agency and the Regional Scientific Ethical Committee. Systolic blood pressure (SBP) must be lower than 180 mm Hg at screening. Patients must be on stable glucose lowering medication for at least two weeks before the first visit. Must be able to communicate with the investigator.

The full record lists 10 inclusion and 16 exclusion criteria; among the exclusions: SBP \> 180 mm Hg at screening; chronic pancreatitis / previous acute pancreatitis; known or suspected hypersensitivity to trial product(s) or related products.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

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 2015-04 with completion listed for 2016-05.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in albuminuria (time frame: 24 weeks).

It also tracked 5 secondary outcomes, for example Change in renin-angiotensin system hormones, Change in kidney function, Change in 24h blood pressure, Change in markers of inflammation and 24h heart rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 32 people.

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

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.