PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide

What Was Tested

In this not phased trial, researchers set out to test Exenatide.

It had three arms (groups): 1 (placebo comparator), 2 (active comparator) and 3 (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 8 planned participants were the target.

It was open to men only aged from 18 years up to 35 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Written informed consent. 18 years ≤ age ≤ 35 years on the day of the first visit. 22.0 ≤ BMI ≤ 28.0 kg/m2. (History of) good physical and mental health as determined by history taking, physical and laboratory examinations and ECG. Able to keep a normal day and night rhythm during the trial period (i.e. no shift work).

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: history or presence of a medical disorder; use of drugs, except for incidental (non-opioid) analgesic agents; first degree relative with t2dm.

How the Study Was Run

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

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2009-02 with completion listed for 2010-01.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Exenatide in 8 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.