Know Cancer

or
forgot password

Pilot Study of Extended-release Exenatide to Improve Glucose Control and Reduce Systemic Inflammation in Diabetic, HIV-infected Adults on Antiretroviral Therapy


Phase 4
18 Years
N/A
Not Enrolling
Both
Human Immunodeficiency Virus Infection, Diabetes Mellitus

Thank you

Trial Information

Pilot Study of Extended-release Exenatide to Improve Glucose Control and Reduce Systemic Inflammation in Diabetic, HIV-infected Adults on Antiretroviral Therapy


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in serum interleukin 6 (IL-6) and highly-sensitive C-reactive protein (hsCRP) levels

Outcome Description:

The primary outcome will be the change in serum IL-6 and hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.

Outcome Time Frame:

16 weeks

Safety Issue:

No

Principal Investigator

John Koethe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

121342

NCT ID:

NCT01791465

Start Date:

March 2013

Completion Date:

August 2014

Related Keywords:

  • Human Immunodeficiency Virus Infection
  • Diabetes Mellitus
  • HIV
  • Diabetes
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Diabetes Mellitus
  • Immunologic Deficiency Syndromes
  • Virus Diseases

Name

Location

Vanderbilt UniversityNashville, Tennessee  37232-6305