Human Immunodeficiency Virus InfectionPhase 4NCT01791465

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

A Phase 4 study testing extended-release exenatide in people with Human Immunodeficiency Virus Infection and Diabetes Mellitus, run by Vanderbilt University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Human Immunodeficiency Virus Infection, Diabetes Mellitus
What is being tested?: extended-release exenatide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Mar 2013to Dec 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

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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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University
Nashville, Tennessee, 37240

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Conditions: Human Immunodeficiency Virus Infection, Diabetes Mellitus
Being tested: extended-release exenatide
Keywords: HIV, Diabetes
Medical subject headings: Acquired Immunodeficiency Syndrome, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

extended-release exenatideDrug
Also called Bydureon
Single arm study - 2mg Bydureon every 7 days x 16 weeks

Study groups in NCT01791465
Study group	Role	What they receive
Bydureon treatment	Experimental	Treatment for 16 weeks with extended-release Exenatide (Bydureon) Receives: Drug: extended-release exenatide

What is being measured

The primary outcome is the main question the study is designed to answer.

Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks
The primary outcome will be the change in hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.
Measured: baseline and 16 weeks
Serum Interleukin 6 (IL-6) at Levels at 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.
Measured: baseline and 16 weeks

Secondary outcomes (18)

Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weeks
Measured: baseline and 16 weeks
Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weeks
Measured: baseline and 16 weeks
Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at Baseline and 16 Weeks
Measured: baseline and 16 weeks
Oral Glucose Insulin Sensitivity (OGIS) at 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.
Measured: baseline and 16 weeks
Serum Adipokine Leptin Levels at Baseline and 16 Weeks
Measured: baseline and 16 weeks
Body Mass Index at Baseline and 16 Weeks
Measured: 16 weeks
Serum TNF-a Receptor 1 Levels at Baseline and 16 Weeks
Measured: baseline and 16 weeks
Serum Soluble CD14 Levels at Baseline and 16 Weeks
Measured: baseline and 16 weeks
Serum TNF-a Receptor 2 Levels at Baseline and 16 Weeks
Measured: baseline and 16 weeks
Serum Hemoglobin A1c (HbA1c) Levels at Baseline and 16 Weeks
Measured: baseline and 16 weeks
Serum Triglycerides Levels at Baseline and 16 Weeks
Measured: baseline and 16 weeks
Serum Total Cholesterol Levels at Baseline and 16 Weeks
Measured: baseline and 16 weeks
Serum HDL Cholesterol Levels at Baseline and 16 Weeks
Measured: baseline and 16 weeks
Serum LDL Cholesterol Levels at Baseline and 16 Weeks
Measured: baseline and 16 weeks
Body Weight at Baseline and 16 Weeks
Measured: baseline and 16 weeks
Waist Circumference at Baseline and 16 Weeks
Measured: baseline and 16 weeks
Hip Circumference at Baseline and 16 Weeks
Measured: baseline and 16 weeks
Waist to Hip Ratio at Baseline and 16 Weeks
Measured: baseline and 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Dec 2014

First posted15 Feb 2013 (estimated)
Study startMar 2013
Primary completionDec 2014
Study completionDec 2014

Why it stopped: This study was terminated after 6 patients due to loss of funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Human Immunodeficiency Virus InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01791465
Sponsor's protocol ID: 121342
Other IDs: P30AI054999
Status last verified: Jan 2017
First submitted: 11 Feb 2013
Last updated: 10 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Individual participant data is protected by HIPPA and Vanderbilt University research regulations. Summary de-identified data is available if requested

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection

All Human Immunodeficiency Virus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Extended-release Exenatide to Improve Glucose Control and Reduce Systemic Inflammation in Diabetic, HIV-infected Adults on Antiretroviral Therapy
ClinicalTrials.gov ID: NCT01791465
Acronym / sponsor ID: 121342
Conditions: Human Immunodeficiency Virus Infection, Diabetes Mellitus
Keywords: HIV, Diabetes
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was terminated after 6 patients due to loss of funding
Enrolment: 6 participants (actual)
Lead sponsor: Vanderbilt UniversityUniversity, hospital or other
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: Mar 2013
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 15 Feb 2013 (estimated)
Results: Posted 10 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Bydureon treatment	Experimental	Drug: extended-release exenatideTreatment for 16 weeks with extended-release Exenatide (Bydureon)

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
extended-release exenatideAlso: BydureonSingle arm study - 2mg Bydureon every 7 days x 16 weeks	Drug	Bydureon treatment

Primary outcome

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.

18 secondary outcomes

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
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

Results and safety

Results posted to the registry on 10 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bydureon Treatment	6	6

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

Time frame: baseline and 16 weeks. Median (Inter-Quartile Range). Unit: mg/dl

Measure	Bydureon Treatment n = 6
baseline	4.0 (2.0 to 14.9)
16 weeks	5.6 (2.4 to 20.3)

Bydureon Treatment: p = 0.08, Wilcoxon (Mann-Whitney)

Population analysed: Change in hsCRP over 16 weeks of treatment

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

Time frame: baseline and 16 weeks. Median (Inter-Quartile Range). Unit: mg/dl

Measure	Bydureon Treatment n = 6
baseline	1.07 (.68 to 3.01)
week 16	1.27 (0.62 to 3.09)

Bydureon Treatment: p = 0.34, Wilcoxon (Mann-Whitney)

18 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bydureon Treatment	0 of 6 (0%)	2 of 6 (33.3%)	Not reported

Limitations and caveats (from the sponsor): Trial terminated after only 6 individuals enrolled due to lack of interest in participation from patients and expiration of funding. Results are not considered reliable due to low number of observations

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Individual participant data is protected by HIPPA and Vanderbilt University research regulations. Summary de-identified data is available if requested

Related trials for Human Immunodeficiency Virus Infection

Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Koethe, MD principal investigator

Vanderbilt University School of Medicine

C. William Wester, MD principal investigator

Vanderbilt University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing extended-release exenatide in people with Human Immunodeficiency Virus Infection and Diabetes Mellitus, run by Vanderbilt University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks (time frame: baseline and 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01791465.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.