Impact of Exenatide on Sleep in Type 2 Diabetes

What Was Tested

The trial (not phased) is built around Exenatide.

This project would be the first to probe the relationship between incretin hormone regulation, duration and intensity of sleep, glucose tolerance and circadian dysfunction in diabetic patients.

It had two arms (groups): Usual T2 DM med regimen (placebo comparator) and Usual T2 DM med regimen plus Exenatide (experimental).

Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.

The registry classes the interventions as drug.

Who Took Part

18 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Patients with a diagnosis of T2DM based on physician documentation according to established guidelines will be eligible.

The full record lists 1 inclusion and 10 exclusion criteria; among the exclusions: patients with unstable cardiac, neurological or psychiatric disease; women who are pregnant or report trying to get pregnant will be excluded; patients treated for obstructive sleep apnea (osa) will be excluded.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

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

It started in 2010-06-01 with completion listed for 2016-09-01.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Non-REM Slow Wave Sleep (time frame: baseline and after 6 weeks of treatment). Total Amount of Slow Wave Activity (time frame: baseline and after 6 weeks of treatment).

It also tracked 4 secondary outcomes, for example Sleep Efficiency During Polysomnographic Recording, Minutes of Wake After Sleep Onset During Sleep Recording, Severity of Obstructive Sleep Apnea and Mean 24-h Blood Glucose Levels.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Exenatide in 18 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page, all human trials.