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

This study has been terminated.
(This study was terminated after 6 patients due to loss of funding)
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
John R. Koethe, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01791465
First received: February 11, 2013
Last updated: January 20, 2017
Last verified: January 2017

February 11, 2013
January 20, 2017
March 2013
December 2014   (Final data collection date for primary outcome measure)
  • Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
    The primary outcome will be the change in hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.
  • Serum Interleukin 6 (IL-6) at Levels at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
    The primary outcome will be the change in serum IL-6 levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.
Change in serum interleukin 6 (IL-6) and highly-sensitive C-reactive protein (hsCRP) levels [ Time Frame: 16 weeks ]
The primary outcome will be the change in serum IL-6 and hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.
Complete list of historical versions of study NCT01791465 on ClinicalTrials.gov Archive Site
  • Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
  • Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
  • Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
  • Oral Glucose Insulin Sensitivity (OGIS) at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
    The Oral Glucose Insulin Sensitivity (OGIS) is a method for the assessment of insulin sensitivity from the oral glucose tolerance test. OGIS provides an index which is analogous to the index of insulin sensitivity obtained from the glucose clamp. OGIS values for glucose clearance are reported in units of ml/min per square meter of body surface area. Lower values indicate slower glucose clearance and higher insulin resistance.
  • Serum Adipokine Leptin Levels at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
  • Body Mass Index at Baseline and 16 Weeks [ Time Frame: 16 weeks ]
  • Serum TNF-a Receptor 1 Levels at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
  • Serum Soluble CD14 Levels at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
  • Serum TNF-a Receptor 2 Levels at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
  • Serum Hemoglobin A1c (HbA1c) Levels at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
  • Serum Triglycerides Levels at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
  • Serum Total Cholesterol Levels at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
  • Serum HDL Cholesterol Levels at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
  • Serum LDL Cholesterol Levels at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
  • Body Weight at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
  • Waist Circumference at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
  • Hip Circumference at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
  • Waist to Hip Ratio at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
  • 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 ]
  • 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 ]
  • The change from baseline to 16 weeks in serum LDL cholesterol, HDL cholesterol, total cholesterol, & triglycerides [ Time Frame: 16 weeks ]
  • The change from baseline to 16 weeks in serum adipokine (leptin and adiponectin) levels [ Time Frame: 16 weeks ]
  • The change from baseline to 16 weeks in body fat mass and distribution, anthropometrics, and body mass index [ Time Frame: 16 weeks ]
Peripheral Endothelial Tonography, as Measured by the Non-invasive EndoPAT System Using the LnRHI (Natural Log of Reactive Hyperemia Index), at Baseline and 16 Weeks [ Time Frame: baseline and 16 weeks ]
Normal: LnRHI > 0.51 Abnormal: LnRHI ≤ 0.51
The change from baseline to 16 weeks in peripheral endothelial tonography, as measured by the non-invasive EndoPAT system [ Time Frame: 16 weeks ]
 
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.
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 reduced inflammation. There was no control arm.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
  • Human Immunodeficiency Virus Infection
  • Diabetes Mellitus
Drug: extended-release exenatide
Single arm study - 2mg Bydureon every 7 days x 16 weeks
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.
 
Terminated
6
December 2014
December 2014   (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)
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01791465
121342
P30AI054999 ( US NIH Grant/Contract Award Number )
No
Not Provided
No
Individual participant data is protected by HIPPA and Vanderbilt University research regulations. Summary de-identified data is available if requested
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 Medical Center
January 2017

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