DelfaGLP-1 Atlas

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TerminatedPhase 4Results posted

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

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

6

actual

Study population

Diabetes (other / unspecified), HIV

Key I/E criteria

•BMI ≥25•HbA1c ≥6.5%

Primary endpoints

•Hs-CRP, change•IL-6

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01791465
Org study ID121342
Secondary IDP30AI054999

Timeline

Milestones

Study first posted2013-02-15estimated
Last update posted2017-03-10actual
Results first posted2017-03-10actual
Study start2013-03 (month precision)
Primary completion2014-12actual (month precision)
Study completion2014-12actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Diabetes (other / unspecified)HIV

Eligibility

Who can enroll

Minimum age18 Years
Maximum age99 Years
SexAll
Healthy volunteersNot accepted

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)

Endpoints (21)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers
14
Weight & body composition
5
Glycemic / diabetes
2

Weight & body composition

5 endpoints
Secondary/protocol endpoint

Body Mass Index at Baseline and 16 Weeks

Time frame:16 weeks

BMI, change

change from baseline, improvement

Posted result

GroupValue (mean), kg/m295% CI
Bydureon Treatmentbaseline32.628.5 – 43.4
16 weeks31.326.9 – 40.2
p0.03Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

Body Weight at Baseline and 16 Weeks

Time frame:baseline and 16 weeks

descriptive

Posted result

GroupValue (mean), kilograms95% CI
Bydureon Treatmentbaseline10087 – 112
16 weeks9681 – 111
p0.046Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

Waist Circumference at Baseline and 16 Weeks

Time frame:baseline and 16 weeks

Waist circumference, change

change from baseline, improvement

Posted result

GroupValue (mean), centimeters95% CI
Bydureon Treatmentbaseline113105 – 134
16 weeks113102 – 132
p0.25Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

Hip Circumference at Baseline and 16 Weeks

Time frame:baseline and 16 weeks

descriptive, improvement

Posted result

GroupValue (mean), centimeters95% CI
Bydureon Treatmentbaseline107102 – 125
16 weeks10397 – 117
p0.12Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

Waist to Hip Ratio at Baseline and 16 Weeks

Time frame:baseline and 16 weeks

descriptive, improvement

Posted result

GroupValue (mean), ratio95% CI
Bydureon Treatmentbaseline1.061.03 – 1.07
16 weeks1.061.05 – 1.12
p0.046Wilcoxon (Mann-Whitney)

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

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

Time frame:baseline and 16 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

GroupValue (mean), ml/min/m^2 BSA95% CI
Bydureon Treatmentbaseline310293 – 369
16 weeks399314 – 480
p0.47Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

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

Time frame:baseline and 16 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), percentage of glycated haemoglobin95% CI
Bydureon Treatmentbaseline7.67.2 – 8.0
16 weeks6.36.0 – 7.7
p0.07Wilcoxon (Mann-Whitney)

Cardiometabolic biomarkers

14 endpoints
Primary/protocol endpoint

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

Time frame:baseline and 16 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Posted result

GroupValue (median), mg/dl95% CI
Bydureon Treatmentbaseline4.02.0 – 14.9
16 weeks5.62.4 – 20.3
p0.08Wilcoxon (Mann-Whitney)
Primary/protocol endpoint

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

Time frame:baseline and 16 weeks

IL-6

change from baseline, improvement

LOINC 26881-3

Posted result

GroupValue (median), mg/dl95% CI
Bydureon Treatmentbaseline1.07.68 – 3.01
week 161.270.62 – 3.09
p0.34Wilcoxon (Mann-Whitney)

The null hypothesis was that there would be no difference between baseline and 16 week IL-6

Secondary/protocol endpoint

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

Time frame:baseline and 16 weeks

change from baseline, improvement

Posted result

GroupValue (mean), pg/ml95% CI
Bydureon Treatmentbaseline2.441.73 – 3.74
16 weeks2.822.4 – 3.90
p0.046Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

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

Time frame:baseline and 16 weeks

MCP-1

change from baseline, improvement

Posted result

GroupValue (mean), pg/ml95% CI
Bydureon Treatmentbaseline5.733.39 – 9.31
16 weeks4.782.93 – 12.3
p0.92Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

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

Time frame:baseline and 16 weeks

CCL3

change from baseline, improvement

Posted result

GroupValue (mean), pg/ml95% CI
Bydureon Treatmentbaseline0.0880.074 – 0.115
16 weeks0.0810.046 – 0.132
p0.69Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

Serum Adipokine Leptin Levels at Baseline and 16 Weeks

Time frame:baseline and 16 weeks

Leptin, change

change from baseline, improvement

Posted result

GroupValue (mean), ng/ml95% CI
Bydureon Treatmentbaseline17.410.3 – 84.6
16 weeks14.310.0 – 77.6
p0.92Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

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

Time frame:baseline and 16 weeks

change from baseline, improvement

Posted result

GroupValue (mean), pg/ml95% CI
Bydureon Treatmentbaseline392311 – 514
16 weeks399332 – 535
p0.60Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

Serum Soluble CD14 Levels at Baseline and 16 Weeks

Time frame:baseline and 16 weeks

sCD14

change from baseline, improvement

Posted result

GroupValue (mean), pg/ml95% CI
Bydureon Treatmentbaseline598458 – 802
16 weeks671562 – 805
p0.08Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

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

Time frame:baseline and 16 weeks

TNF-alpha-R2

change from baseline, improvement

Posted result

GroupValue (mean), pg/ml95% CI
Bydureon Treatmentbaseline598458 – 802
16 weeks671562 – 805
p0.08Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

Serum Triglycerides Levels at Baseline and 16 Weeks

Time frame:baseline and 16 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

GroupValue (mean), mg/dL95% CI
Bydureon Treatmentbaseline172100 – 245
16 weeks118110 – 189
p0.69Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

Serum Total Cholesterol Levels at Baseline and 16 Weeks

Time frame:baseline and 16 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

GroupValue (mean), mg/dL95% CI
Bydureon Treatmentbaseline192158 – 220
16 weeks176146 – 211
p0.50Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

Serum HDL Cholesterol Levels at Baseline and 16 Weeks

Time frame:baseline and 16 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

GroupValue (mean), mg/dL95% CI
Bydureon Treatmentbaseline3935 – 45
16 weeks3431 – 47
p0.42Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

Serum LDL Cholesterol Levels at Baseline and 16 Weeks

Time frame:baseline and 16 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

GroupValue (mean), mg/dL95% CI
Bydureon Treatmentbaseline12791 – 134
16 weeks10980 – 145
p0.89Wilcoxon (Mann-Whitney)
Other/protocol endpoint

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

change from baseline, improvement

Posted result

GroupValue (mean), units on a scale95% CI
Bydureon Treatmentbaseline0.710.42 – 0.93
16 weeks0.620.59 – .77
p0.75Wilcoxon (Mann-Whitney)

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.