Safety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function

What Was Tested

In this phase 1 trial, researchers set out to test Liraglutide.

This trial is conducted in Oceania.

It had five arms (groups): Normal renal function (experimental), Mild renal impairment (experimental), Moderate renal impairment (experimental), Severe renal impairment (experimental) and End-stage renal disease (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Subjects meeting the pre-defined GFR (glomerular filtration rate) criteria (estimated by the Cockcroft and Gault formula) for any of the renal function groups. Body Mass Index (BMI) maximum 40 kg/m\^2.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: known or suspected allergy to trial product(s) or related products; renal transplanted patients; haemodialysis patients.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.

It started in 2005-08 with completion listed for 2006-03.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the Curve (AUC).

It also tracked 6 secondary outcomes, for example AUC (0-t), Cmax, maximum concentration, tmax, time to reach Cmax, t½, terminal half-life, CLR (renal clearance) and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Liraglutide in 30 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.