Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults

What Was Tested

The trial (phase 4) is built around Exenatide.

This pilot study will evaluate the effects of the anti-diabetic drug Bydureon (exenatide extended-release formulation) on blood sugar levels and serum markers of inflammation in a cohort of 12 HIV-infected adults on combination antiretroviral therapy (cART) with untreated diabetes mellitus.

It had 1 arm (groups): Bydureon treatment (experimental).

Treatment for 16 weeks with extended-release Exenatide (Bydureon).

The registry classes the interventions as drug.

More on the Plan

This was a single-arm trial to add an additional anti-diabetic medication to patients already known to be diabetic.

There was no control arm.

Who Took Part

6 actual participants took part.

It was open to people of any sex aged from 18 years up to 99 years.

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

Examples of who could join: Age ≥ 18 years. Body mass index ≥ 25 kg/m2. On stable antiretroviral therapy for ≥ 12 months (with a fully suppressed plasma HIV-1 RNA level). Negative serum pregnancy test (females only).

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-03 with completion listed for 2014-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks (time frame: baseline and 16 weeks). Serum Interleukin 6 (IL-6) at Levels at Baseline and 16 Weeks (time frame: baseline and 16 weeks).

It also tracked 18 secondary outcomes, for example Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weeks, Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weeks, Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at Baseline and 16 Weeks, Oral Glucose Insulin Sensitivity (OGIS) at Baseline and 16 Weeks, Serum Adipokine Leptin Levels at Baseline and 16 Weeks and Body Mass Index at Baseline and 16 Weeks.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Exenatide in 6 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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