Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases

What Was Tested

The trial (phase 2) is built around Exenatide.

Insulin therapy is based on long lasting basal insulin for controlling fasting plasma glucose, and short lasting mealtime insulin for the postprandial plasma glucose.

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

Exenatide 10 mikrogram, thrice daily, subcutaneous injection prior to main meals, 6 months.

Placebo, thrice daily, subcutaneous injection prior to main meals, 6 months.

The registry classes the interventions as drug.

Who Took Part

The registry lists 108 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: T1D according to WHO criteria with duration of ≥1 year. Age ≥18 years. BMI \>22.0 kg/m2. Able to count carbohydrates.

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: insulin pump treatment; hypoglycaemia unawareness (inability to register low blood glucose); diabetic gastroparesis.

How the Study Was Run

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

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

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

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 2016-12 with completion listed for 2019-06.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (time frame: 6 months).

It also tracked 21 secondary outcomes, for example adverse events (including hypoglycaemic episodes), changes in body weight, changes in BMI, changes in body composition, changes in body composition and changes in body composition.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 108 people.

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.