A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)

What Was Tested

The trial (phase 1) is built around Lixisenatide.

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

The registry classes the interventions as drug.

Who Took Part

23 actual participants took part.

It was open to people of any sex aged from 10 years up to 17 years.

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

Examples of who could join: Male or female patients aged ≥10 and \<18 years old (at least 4 patients below 16 years old). Body mass index (BMI) \>85th percentile for age and gender; BMI ≤50 kg/m2.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: if female, ongoing pregnancy (defined as positive serum pregnancy test), breast-feeding; diabetes other than t2dm; history of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease.

How the Study Was Run

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

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

The Lixisenatide group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: care provider.

It started in 2017-05-17 with completion listed for 2020-01-27.

It ran at 11 sites in United States (4), Mexico (2), Turkey (Türkiye) (2), Mauritius (1), South Africa (1) and Spain (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of patients with adverse events (AEs) (time frame: Up to 10 weeks). Number of patients with treatment-emergent adverse events (TEAEs) (time frame: Up to 10 weeks). Number of patients with anti-lixisenatide antibodies (time frame: Up to 10 weeks).

It also tracked 6 secondary outcomes, for example Assessment of PK parameters: maximum concentration (Cmax), Assessment of PK parameters: time to reach Cmax (Tmax), Assessment of PK parameters: area under up to last concentration (AUClast) and Assessment of PK parameters: area under curve (AUC).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Lixisenatide in 23 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 Lixisenatide compound page, all human trials.