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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Vanderbilt University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John R. Koethe, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01791465
First received: February 11, 2013
Last updated: February 13, 2013
Last verified: February 2013

February 11, 2013
February 13, 2013
March 2013
August 2013   (final data collection date for primary outcome measure)
Change in serum interleukin 6 (IL-6) and highly-sensitive C-reactive protein (hsCRP) levels [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
The primary outcome will be the change in serum IL-6 and hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.
Same as current
Complete list of historical versions of study NCT01791465 on ClinicalTrials.gov Archive Site
  • Change from baseline to 16 weeks in serum levels of soluble tumor necrosis factor alpha (TNF-α) receptor 1 & 2, cystatin C, macrophage chemotactic protein-1 (MCP-1), macrophage inflammatory protein 1 alpha (MIP-1α), and interleukin 1 beta (IL-1β) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • The change from baseline to 16 weeks in the response to an oral glucose tolerance challenge and in serum hemoglobin A1c levels [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • The change from baseline to 16 weeks in serum LDL cholesterol, HDL cholesterol, total cholesterol, & triglycerides [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • The change from baseline to 16 weeks in serum adipokine (leptin and adiponectin) levels [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • The change from baseline to 16 weeks in body fat mass and distribution, anthropometrics, and body mass index [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
The change from baseline to 16 weeks in peripheral endothelial tonography, as measured by the non-invasive EndoPAT system [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
 
Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults
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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Human Immunodeficiency Virus Infection
  • Diabetes Mellitus
Drug: extended-release exenatide
Other Name: Bydureon
Experimental: Bydureon treatment
Treatment for 16 weeks with extended-release Exenatide (Bydureon)
Intervention: Drug: extended-release exenatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
12
August 2014
August 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Vicki Bailey 615-936-7143 vicki.bailey@vanderbilt.edu
Contact: John Koethe, MD 615-322-2035 john.r.koethe@vanderbilt.edu
United States
 
NCT01791465
121342, P30AI054999
No
John R. Koethe, Vanderbilt University
Vanderbilt University
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: John Koethe, MD Vanderbilt University School of Medicine
Principal Investigator: C. William Wester, MD Vanderbilt University School of Medicine
Vanderbilt University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP