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Trial · Interventional

TerminatedPhase 4Results postedRegistry data

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

NCTNCT01791465 (opens ClinicalTrials.gov in a new tab)Other id121342Other idP30AI054999
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 4
Enrollment
6 participants (actual)
Sponsor
Vanderbilt University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Mar 2013
Primary completion
Dec 2014
Completion
Dec 2014
First posted
15 Feb 2013 (estimated)
Last update posted
10 Mar 2017
Conditions
Human Immunodeficiency Virus Infection · Diabetes Mellitus

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 4

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

    NCT01791465

    Mar 2013 to Dec 2014

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • extended-release exenatideDrug

Arms1

  • Experimental

    Bydureon treatment

    Treatment for 16 weeks with extended-release Exenatide (Bydureon)

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

    Registry description

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

  2. Serum Interleukin 6 (IL-6) at Levels at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

    Registry description

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

Secondary outcomes(18)

  1. Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

  2. Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

  3. Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

  4. Oral Glucose Insulin Sensitivity (OGIS) at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

    Registry description

    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.

  5. Serum Adipokine Leptin Levels at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

  6. Body Mass Index at Baseline and 16 Weeks

    Time frame · 16 weeks

  7. Serum TNF-a Receptor 1 Levels at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

  8. Serum Soluble CD14 Levels at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

  9. Serum TNF-a Receptor 2 Levels at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

  10. Serum Hemoglobin A1c (HbA1c) Levels at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

  11. Serum Triglycerides Levels at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

  12. Serum Total Cholesterol Levels at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

  13. Serum HDL Cholesterol Levels at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

  14. Serum LDL Cholesterol Levels at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

  15. Body Weight at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

  16. Waist Circumference at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

  17. Hip Circumference at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

  18. Waist to Hip Ratio at Baseline and 16 Weeks

    Time frame · baseline and 16 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· baseline and 16 weeks

Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks

GroupValue (mg/dl)
Bydureon Treatment4.0
Primary outcomeMedian· baseline and 16 weeks

Serum Interleukin 6 (IL-6) at Levels at Baseline and 16 Weeks

GroupValue (mg/dl)
Bydureon Treatment1.07
Secondary and other outcome results(6)
Secondary outcomeMean· baseline and 16 weeks

Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weeks

GroupValue (pg/ml)
Bydureon Treatment2.44
Secondary outcomeMean· baseline and 16 weeks

Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weeks

GroupValue (pg/ml)
Bydureon Treatment5.73
Secondary outcomeMean· baseline and 16 weeks

Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at Baseline and 16 Weeks

GroupValue (pg/ml)
Bydureon Treatment0.088
Secondary outcomeMean· baseline and 16 weeks

Oral Glucose Insulin Sensitivity (OGIS) at Baseline and 16 Weeks

GroupValue (ml/min/m^2 BSA)
Bydureon Treatment310
Secondary outcomeMean· baseline and 16 weeks

Serum Adipokine Leptin Levels at Baseline and 16 Weeks

GroupValue (ng/ml)
Bydureon Treatment17.4
Secondary outcomeMean· 16 weeks

Body Mass Index at Baseline and 16 Weeks

GroupValue (kg/m2)
Bydureon Treatment32.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Bydureon TreatmentTreatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons–0 / 62 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 99 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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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