Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS, Diabetes |
| Therapuetic Areas: | Endocrinology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | March 2013 |
| End Date: | August 2014 |
| Contact: | Vicki Bailey |
| Email: | vicki.bailey@vanderbilt.edu |
| Phone: | 615-936-7143 |
Pilot Study of Extended-release Exenatide to Improve Glucose Control and Reduce Systemic Inflammation in Diabetic, HIV-infected Adults on Antiretroviral Therapy
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.
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.
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)
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