Effects of Insulin Glargine and Lixisenatide on the Brain

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine.

Background During the last years, the brain has been identified as a major insulin-sensitive organ .

The investigators and also other scientists identified hypothalamus, fusiform gyrus and prefrontal cortex as major insulin-sensitivity brain areas in humans .

Brain insulin action regulates important physiological functions in humans such as food intake, body weight regulation, and cognition.

It had two arms (groups): iGlarLixi (active comparator) and Insulin glargine (active comparator).

Subjects will receive premixed Insulin glargine + lixisenatide once daily for 12 weeks.

Subjects will receive Insulin glargine once daily for 12 weeks.

The registry classes the interventions as drug.

Who Took Part

1 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Must be between 18 and 65 years at the time of signing the informed consent. BMI 25-45 kg/m². Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures. Ability to adhere to the study visit schedule and other protocol requirements. Females of childbearing potential (FCBP) must agree.

The full record lists 13 inclusion and 41 exclusion criteria; among the exclusions: women during pregnancy and lactation; use of oral glucose-lowering agents other than those stated in the inclusion criteria or any injectable glucose-lowering agents during 3 months before screening; patient who has previously participated in any clinical trial with lixisenatide or the insulin glargine + lixisenatide fixed ratio combination or has previously received lixisenatide.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2019-03-18 with completion listed for 2020-06-29.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Brain insulin sensitivity (time frame: Change from baseline brain insulin sensitivity at 12 weeks).

It also tracked 16 secondary outcomes, for example Processing of food pictures, Cognitive function, Cognitive function, Cognitive function, Cognitive function and Cognitive function.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 1 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.