Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults
Condition: Human Immunodeficiency Virus Infection; Diabetes Mellitus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: extended-release exenatide
Intervention description: Single arm study - 2mg Bydureon every 7 days x 16 weeks
Intervention MeSH terms: Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: HIV; Diabetes

Summary:

      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.
    

Eligibility criteria:

        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)