Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients

What Was Tested

This registered phase 4 trial tested Liraglutide.

Recent studies in rodents show that glucagon-like peptide-1 (GLP-1) analogues protect against diabetic nephropathy.

The researchers hypothesise that this is also the case in humans.

This study will investigate the short-term effect of liraglutide (GLP-1 analogue) on the kidneys in type 2 diabetic patients.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 11 actual participants took part.

It was open to men only aged from 20 years up to 60 years.

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

Examples of who could join: Informed consent obtained before any trial-related activities. T2DM, diagnosed according to international guidelines. Age 20-60 years, both included. Body Mass Index (BMI): 20-32 kg/m2, both included.

The full record lists 7 inclusion and 19 exclusion criteria; among the exclusions: known or suspected allergy to trial product or related products; previous participation in this trial; previous treatment with glp-1 analogues or dpp-4 inhibitors.

How the Study Was Run

Design: randomized, crossover and double-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.

In the crossover set-up each of the participants took both Liraglutide and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant and investigator.

It started in 2012-12 with completion listed for 2014-02.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Glomerular Filtration Rate (51Cr-EDTA plasma clearance).

It also tracked 4 secondary outcomes, for example Renal Blood Flow (functional magnetic resonance imaging), Renal electrolyte clearance, Excretion of kidney injury markers and Plasma concentrations of various hormones.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 11 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.