Human Bioequivalence Test of Liraglutide Injection

What Was Tested

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

It had two arms (groups): Liraglutide injection + Victoza (experimental) and Victoza +Liraglutide injection (experimental).

Subjects receive liraglutide injection in the first cycle and Victoza in the second cycle.

Subjects receive Victoza in the first cycle and liraglutide injection in the second cycle.

The registry classes the interventions as drug.

Who Took Part

28 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Sign the informed consent form before the trial, fully understand the trial purpose, process and possible adverse reactions;. Able to complete the study according to the requirements of protocol;. Aged between 18 and 60 years old, both men and women;. Male ≥50kg, female ≥45kg,body mass index(BMI)=weight (kg)/height 2 (m2), BMI is 18-28 kg/m2 (including the critical value);. No mental abnormalities, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system or metabolic abnormalities;.

The full record lists 7 inclusion and 18 exclusion criteria; among the exclusions: have a history of fainting needles, fainting blood;; known allergy to liraglutide and its metabolites or any of the excipients of the formulation;; those who smoked more than 5 cigarettes per day during the 3 months before the trial.

How the Study Was Run

The set-up was randomized, crossover and open-label.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Liraglutide and the comparison in turn, acting as their own control.

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 2019-05-21 with completion listed for 2019-06-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Maximum (peak) plasma drug concentration(Cmax). Time to reach maximum (peak) plasma concentration following drug administration (Tmax). Area under the plasma concentration-time curve from time zero to time t (AUC0-t).

It also tracked 6 secondary outcomes, for example body temperature, pulse, blood pressure, clinical symptoms, The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination) and The Number of participants with abnormal laboratory examinations.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 28 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.