Effect of Liraglutide on Absorption of Paracetamol in Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 1) is built around Liraglutide.

This trial is conducted in Europe.

The aim of this trial is to to investigate if there is a drug-drug interaction between liraglutide and paracetamol (Benuron®) and to investigate the effect of liraglutide on post prandial glucose.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 18 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: Type 2 diabetes mellitus. Body mass index (BMI) 18.5-40 kg/m\^2. Subjects should have a stable body weight for at least 3 months prior to screening (as judged by the Investigator).

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: impaired liver function; impaired renal function; uncontrolled treated/untreated hypertension.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

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 and investigator.

It started in 2006-10 with completion listed for 2007-05.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the curve of paracetamol. Area under the curve of post prandial plasma glucose.

It also tracked 6 secondary outcomes, for example Area under the curve of paracetamol, Cmax, maximum concentration, tmax, time to reach Cmax, t½, terminal half-life, Terminal elimination rate constant and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 18 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.