DECREASE: Dapagliflozin Plus Exenatide on Central REgulation of Appetite in diabeteS typE 2

What Was Tested

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

This is a 16 week, phase 4, randomized and placebo controlled trial, investigating the separate and combined effects of Sodium Glucose coTransporter 2 (SGLT2) inhibition with dapagliflozin and Glucagon Like peptide-1 (GLP-1) receptor agonism with exenatide on food intake, body weight and the neural activity in the central satiety and reward circuits in response to food-related stimuli by blood oxygen level-dependent (BOLD) fMRI in obese type 2 diabetes patients.

It had four arms (groups): SGLT2 inhibitor + GLP-1 receptor agonist (experimental), GLP-1 receptor agonist (exenatide) and placebo (active comparator), SGLT2 inhibitor (dapagliflozin) and placebo (active comparator) and double placebo (placebo comparator).

GLP-1 receptor agonist exenatide twice daily in combination with placebo dapagliflozin.

The registry classes the interventions as drug and other.

More on the Plan

To correlate changes in brain activity with subsequent feeding behavior, the investigators will measure food intake, self-reported hunger, satiety and mood, during a choice-buffet after the scanning.

Expected results: This project will gain insight into the CNS mechanisms underlying the the effects of seperate and combined treatment with SGLT2 inhibition and GLP-1 receptor agonism.

Who Took Part

The registry lists 65 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Age 18-75 years. BMI 27-40 kg/m2. Diagnosed with T2DM \> 3 months prior to screening. For women: post menopausal (excluding possible menstruation cycle effects).

The full record lists 8 inclusion and 30 exclusion criteria; among the exclusions: GLP-1 based therapies, DDP-4 inhibitors, SGLT-2 inhibitors, thiazolidinediones or insulin within 3 months before screening; weight-lowering agents within 3 months before screening; congestive heart failure (nyha ii-iv).

How the Study Was Run

The set-up was randomized, factorial and double-blind.

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

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 and investigator.

It started in 2017-09-18 with completion listed for 2019-11-25.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Differences in neuronal activity in the central reward and satiety circuits in response to food-related stimuli by BOLD fMRI signal (time frame: at baseline, after 10 days and after 16 weeks).

It also tracked 12 secondary outcomes, for example Differences in neuronal activity in the central reward and satiety circuits in response to food-related stimuli by BOLD fMRI signal, Feeding behaviour; ad libitum lunch buffet, Feeding behaviour; ad libitum lunch buffet, Self-reported hunger, Difference in resting energy expenditure measured by indirect calorimetry measurements and Change in bodyweight (kg) and body mass index (kg/m2).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 65 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.