Effect of Liraglutide on Gastrointestinal Absorption of Several Drugs and Potential Influence of Liraglutide on Intragastric pH

What Was Tested

This registered phase 1 trial tested Liraglutide.

The trial is conducted in Europe.

The aim of the trial is to investigate if there is any drug to drug interaction between liraglutide and atorvastatin (Lipitor®), lisinopril (Zestril®), griseofulvin and digoxin (Lanoxin®).

It had two arms (groups): Trial period A (experimental) and Trial period B (experimental).

The registry classes the interventions as drug.

Who Took Part

70 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Female subjects if using adequate anti-contraception or is sterile. Body Mass Index (BMI) of 18-30 kg/m\^2 (both inclusive). Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments. Willing and capable to self-administer a subcutaneous injection.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: impaired renal function; blood pressure and heart rate in supine position outside the ranges 90-140 mmhg systolic, 50-90 mmhg diastolic and heart rate 40-100 beats/min; active hepatitis b and/or active hepatitis c.

How the Study Was Run

Design: randomized, crossover and double-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.

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant and investigator.

It started in 2006-05 with completion listed for 2007-04.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the curve of atorvastatin. Area under the curve of lisinopril. Area under the curve of griseofulvin.

It also tracked 6 secondary outcomes, for example Area under the curve of liraglutide, Cmax, maximum concentration, tmax, time to reach Cmax, Terminal elimination rate constant, Intragastric pH and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 70 people.

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.