Exenatide and Impaired Hypoglycaemic Awareness in Type 1 Diabetes

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Exenatide.

IHA is usually the end-result of a process of habituation to recurrent hypoglycemia that is potentially reversible.

It had two arms (groups): EXENATIDE (active comparator) and PLACEBO (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Type 1 diabetes, disease duration \>1 year. Age \>18 years, \<70 years. Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump). Impaired hypoglycaemic awareness as assessed by a score of 3 or more on the modified Dutch translation of the Clarke questionnaire. Ability to provide informed consent.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: treatment with incretin-based therapy; known intolerance to glp-1ras (including allergy); treatment with glucose-modifying or immune-modifying agents, e.g. prednisolon.

How the Study Was Run

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

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

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

Neither the participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-02-21 with completion listed for 2018-03-28.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Symptom score in response to insulin-induced hypoglycaemia (time frame: 30 minutes).

It also tracked 14 secondary outcomes, for example Adrenaline response to insulin-induced hypoglycaemia, Glucagon response to insulin-induced hypoglycaemia, Time until glycaemic recovery from hypoglycaemia, Maximal glucose excursion post-hypoglycaemia, Time until glucose peak post-hypoglycaemia and Area under the glucose concentration curve post-hypoglycaemia.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Exenatide in 10 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 Exenatide compound page, all human trials.