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

Vanderbilt University

Status and phase

Terminated

Phase 4

Conditions

Human Immunodeficiency Virus Infection

Diabetes Mellitus

Treatments

Drug: extended-release exenatide

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01791465

P30AI054999 (U.S. NIH Grant/Contract)

121342

Details and patient eligibility

About

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.

Full description

No further information. This was a single-arm trial to add an additional anti-diabetic medication to patients already known to be diabetic. The primary endpoint assessed whether the intervention reduced inflammation. There was no control arm.

Enrollment

6 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years
Body mass index ≥ 25 kg/m2
Glycosylated hemoglobin (A1C) value ≥ 6.5% OR having a fasting blood glucose ≥ 126 mg/dL
On stable antiretroviral therapy for ≥ 12 months (with a fully suppressed plasma HIV-1 RNA level)
Negative serum pregnancy test (females only)

Exclusion criteria

History of pancreatitis
Screening serum lipase value greater than or equal to 2 times the upper limit of normal (≥ 420 U/L)
History of pancreatic cancer or thyroid cancer in patient, a first-degree relative, or a grandparent
History of Multiple Endocrine Neoplasia (MEN) 2 syndrome
History of gastroparesis, inflammatory bowel disease, and/or other severe gastrointestinal disease
Estimated glomerular filtration rate (eGFR) ≤ 50 mls/minute
Documented history of hypoglycemia (blood glucose <40 mg/dl)
Active moderate-heavy alcohol use (more than 2 drinks/day) or >4 drinks in a single 24 hour period
On an anti-diabetic medication within 3 months of enrollment
On an HMG-CoA reductase inhibitor (statin) within 3 months of enrollment
Persons on a didanosine (ddI) and/or stavudine (d4T)-containing cART (due to the heightened risk of pancreatitis)