Effects of Combined Dapagliflozin and Exenatide Versus Dapagliflozin and Placebo on Ectopic Lipids in Patients With Uncontrolled Type 2 Diabetes Mellitus.

What Was Tested

This registered phase 4 trial tested Exenatide.

It had two arms (groups): Dapagliflozin & Exenatide (active comparator) and Dapagliflozin & Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 34 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: Sex: male and female. HbA1c \>=6.5 and \<=11. Age \>=18 and \<=75 years. Able and willing to not change diet and physical activity during enrollment in study. Consent and able to give informed consent.

The full record lists 7 inclusion and 33 exclusion criteria; among the exclusions: other diabetes diagnosis than t2dm; patients on other antidiabetic medication (sulfonylurea, glitazone, insulin for more than 2 weeks (see below), sglt2 inhibitors, glp1 agonist, nateglinide, repaglinide, acarbose, dpp4 inhibitors); known intolerance against study medication.

How the Study Was Run

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

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

The Exenatide group and the comparison group ran side by side rather than switching.

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2017-03-08 with completion listed for 2019-11-26.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: change in hepatic lipid content measured with magnetic resonance spectroscopy in % (time frame: baseline - week 24).

It also tracked 11 secondary outcomes, for example change in myocardial lipid content measured with magnetic resonance spectroscopy in %, change in pancreatic lipid content measured with magnetic resonance spectroscopy in %, Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, Quality of Life questionnaire, change in insulin resistance and change in insulin sensitivity.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 34 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.