A Trial to Assess the Effect of Liraglutide on Blood Triglyceride (Fat) Levels After a Meal in Type 2 Diabetics

What Was Tested

The trial (phase 1) is built around Liraglutide.

This trial is conducted in Europe.

It had two arms (groups): A (experimental) and B (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Subjects with type 2 diabetes mellitus (diet and exercise treated, or treated with specific oral antidiabetics (metformin, sulfonylureas and glinides) mono- or combination therapy) diagnosed at least 3 months previously. BMI between 18.5 and 40 kg/m2.

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: known or suspected allergy to trial products or related products; previous participation in this trial (randomised). re-screening of screening failures is allowed only once; the receipt of any investigational drug within 3 months prior to this trial.

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.

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 2009-10 with completion listed for 2010-12.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): AUC0-8h (triglyceride), the area under the triglyceride-concentration-time curve in the interval 0-8 hours following a meal with a high fat content (time frame: after 3 weeks of treatment).

It also tracked 2 secondary outcomes, for example FFA (Free Fatty Acid), VLDL (Very Low Density), and apoB48: AUC0-8 hours after meal with a high fat content and Glucose, insulin, C-peptide and glucagon: AUC0-8 hours after meal with a high fat content.

What This Means in Plain Language

Put simply, this is a phase 1, 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; no results are posted to the registry yet, so nothing here describes outcomes.

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