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

Phase 4TerminatedNCT01791465

Vanderbilt University6 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Human Immunodeficiency Virus Infection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks

The primary outcome will be the change in hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.