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

NCT01791465 · Terminated

Last updated 2026-05-28

This study tests whether Bydureon, a diabetes medication, can reduce inflammation in adults living with both HIV and diabetes over a 16-week period.

Status Terminated Stopped early and will not restart.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design open-label (no blinding) treatment study

Participants 6 people

Who can join Ages 18–99 · all sexes

Timeline Started 2013-03 · est. completion 2014-12

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT01791465 ↗

Description as written by the study sponsor.

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. Previous studies have shown that high levels of persistent systemic inflammation predict the development of cardiovascular and metabolic diseases in HIV-infected persons on cART (a group at very high risk of atherosclerosis and myocardial infarction). Bydureon has demonstrated potent anti-inflammatory effects in prior studies of non-HIV infected persons, which suggests that this agent may represent a unique and preferred medication for the treatment of insulin resistance in HIV-infected adults. The Investigators hypothesize that short-term (16 weeks) therapy with Bydureon will improve glucose tolerance and significantly reduce circulating plasma levels of interleukin-6 (IL-6) and highly-sensitive C-reactive protein (hsCRP), two biomarkers strongly implicated in the development of cardiovascular and metabolic diseases in diabetic, HIV-infected, cART-treated adults.

Treatments tested

extended-release exenatide also known as Bydureon Drug

Single arm study - 2mg Bydureon every 7 days x 16 weeks

Main thing measured	Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks
Sponsor	Vanderbilt University
Conditions studied	Human Immunodeficiency Virus Infection, Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01791465 ↗