The Effect of Lixisenatide on the Effect of Pituitary Hormones

What Was Tested

The trial (phase 4) is built around Lixisenatide.

The secondary objective of the study is to monitor the effect of lixisenatide on other pituitary hormones and physiological parameters (blood glucose, blood pressure, heart rate, nausea).

The registry classes the interventions as drug.

More on the Plan

The randomized, blinded, placebo-controlled clinical trial is conducted on 5 healthy volunteers and 5 patients with type 1 diabetes.

The order of administration of study medication is decided on randomization.

The placebo and lixisenatide are administered at least 2 days apart.

Who Took Part

The registry lists 10 planned participants were the target.

It was open to men only aged from 18 years up to 60 years.

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

Examples of who could join: Age 18-60 years. Body weight \> 65 kg. Patients with type 1 diabetes:. Type 1 diabetes. Age 18-60 years.

The full record lists 11 inclusion and 9 exclusion criteria; among the exclusions: healthy volunteers:; use of aldosterone antagonist; use of glucocorticosteroid.

How the Study Was Run

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

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

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

In this single-blind Lixisenatide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2023-04-17 with completion listed for 2023-10-31.

It ran at 1 site in Estonia.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Growth hormone area under the curve (time frame: 0-150 minutes after study drug administration).

It also tracked 8 secondary outcomes, for example Growth hormone peak, Glucose nadir, C-peptide peak, Cortisol peak, Adrenocorticotropic hormone (ACTH) peak and Prolactin peak.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Lixisenatide in 10 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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