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NCT01791465 · ClinicalTrials.gov registry record · Phase 4
Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults
A Phase 4 study, sponsored by Vanderbilt University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 6
- Enrollment target
NCT01791465 is a Phase 4 study that was terminated before completion, run by Vanderbilt University. The registered enrollment target is 6 participants.
The verdict
NCT01791465, a Phase 4 study, was terminated before completion, sponsored by Vanderbilt University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 6 participants
- Enrollment target
Study 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-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
- DRUG extended-release exenatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01791465
The ClinicalTrials.gov registry entry for NCT01791465 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which extended-release exenatide is the first listed.
NCT01791465 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01791465 about?
NCT01791465 is a clinical study titled "Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults". 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...
What is the current status of trial NCT01791465?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2013-03. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01791465?
The interventions under investigation include: extended-release exenatide (DRUG).
Who is sponsoring clinical trial NCT01791465?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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