Study on Lixisenatide and Counterregulation to Hypoglycemia

What Was Tested

The trial (phase 4) is built around Lixisenatide.

In hypoglycemia, there is a counterregulation to restore glucose levels.

An important part of this counterregulation is the release of the hormone glucagon.

It had 1 arm (groups): Lixisenatide (experimental).

The registry classes the interventions as drug.

More on the Plan

The study is a single-center, randomized, placebo-controlled study with a cross-over design and examines the glucagon response during a hyperinsulinemic hypoglycemic phase after a 6-week treatment with lixisenatide (or placebo) as add-on to basal insulin and metformin.

The hypothesis of the study is that the glucagon counterregulation to hypoglycemia in patients treated with lixisenatide and basal insulin is not lower than in patients treated with basal insulin.

Who Took Part

18 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: Male, non-fertile female or female of childbearing potential using a medically approved birth control method aged \>18 years.

The full record lists 3 inclusion and 15 exclusion criteria; among the exclusions: treatment with antihyperglycemic agents apart from basal insulin and metformin, i.e., bolus insulin or other antihyperglycemic oral agents apart from metformin; type 1 diabetes (including lada); A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Lixisenatide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-12 with completion listed for 2014-08.

It ran at 1 site in Sweden.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Glucagon response to hypoglycemia (time frame: 30 min).

It also tracked 2 secondary outcomes, for example Cortisol response to hypoglycemia and Catecholamines.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Lixisenatide in 18 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.