Status:
TERMINATED
Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Human Immunodeficiency Virus Infection
Diabetes Mellitus
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief 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-inf...
Detailed 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 reduc...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01791465
Start Date
March 1 2013
End Date
December 1 2014
Last Update
March 10 2017
Active Locations (1)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37240