The Effect of Glucagon-like-peptide 1 (GLP-1) Receptor Agonism on Diabetic Kidney Disease

What Was Tested

This registered phase 3 trial tested Liraglutide.

This study aims to test this theory by studying the effect of GLP-1 on kidney function in people with diabetes.

It had two arms (groups): Liraglutide (active comparator) and Control (no intervention).

Standard diabetes care including renin angiotensin aldosterone system inhibitor or antagonist.

The registry classes the interventions as drug.

More on the Plan

A randomised controlled trial for patients with microalbuminuria and type 2 diabetes.

Treatment duration is 6 months.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 30 years up to 75 years.

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

Examples of who could join: Male or female aged above 30 years. Have a negative pregnancy test at screening (women of child bearing potential only). Body mass index (BMI) of 25kg/m2 or greater.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: patients with any cognitive impediment that preclude the patient from giving free and informed consent; patients on dipeptidyl peptidase 4 inhibitors or thiazolidinedione treatment; patients who have used a glp-1 agent in the last 6 months.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-04 with completion listed for 2015-11.

It ran at 1 site in Ireland.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: MCP-1:Creatinine Ratio in Urine (time frame: Up to 26 weeks).

It also tracked 4 secondary outcomes, for example Urine Albumin:Creatinine Ratio, Urinary Albumin Excretion Rate, sCD163 in Serum and sCD163:Creatinine Ratio in Urine.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 20 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.