Phase 4 · Exenatide

NCT01791465 trial results

Pilot Study of Extended-release Exenatide to Improve Glucose Control and Reduce Systemic Inflammation in Diabetic, HIV-infected Adults on Antiretroviral Therapy

Participants: 6
Status: terminated
Completed: 2014-12
Sponsor: Vanderbilt University

As posted on ClinicalTrials.gov (NCT01791465), updated at source Mar 10, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01791465 measured first

Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeksmg/dl · baseline and 16 weeks · median

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

Serum Interleukin 6 (IL-6) at Levels at Baseline and 16 Weeksmg/dl · baseline and 16 weeks · median

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

Side effects by arm

Side effects in NCT01791465

Percent of participants affected. The most common events the registry lists.

Event	Bydureon Treatment
Any serious event	0%
Fatigue and weakness	33.3%

Secondary outcomes

What else it measured

Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weekspg/ml · baseline and 16 weeks · mean

Measure	Bydureon Treatmentn=6
baseline	2.44(1.73 to 3.74)
16 weeks	2.82(2.4 to 3.90)

Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weekspg/ml · baseline and 16 weeks · mean

Measure	Bydureon Treatmentn=6
baseline	5.73(3.39 to 9.31)
16 weeks	4.78(2.93 to 12.3)

Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at Baseline and 16 Weekspg/ml · baseline and 16 weeks · mean

Measure	Bydureon Treatmentn=6
baseline	0.088(0.074 to 0.115)
16 weeks	0.081(0.046 to 0.132)

Oral Glucose Insulin Sensitivity (OGIS) at Baseline and 16 Weeksml/min/m^2 BSA · baseline and 16 weeks · mean

Measure	Bydureon Treatmentn=6
baseline	310(293 to 369)
16 weeks	399(314 to 480)

Serum Adipokine Leptin Levels at Baseline and 16 Weeksng/ml · baseline and 16 weeks · mean

Measure	Bydureon Treatmentn=6
baseline	17.4(10.3 to 84.6)
16 weeks	14.3(10.0 to 77.6)

Body Mass Index at Baseline and 16 Weekskg/m2 · 16 weeks · mean

Measure	Bydureon Treatmentn=6
baseline	32.6(28.5 to 43.4)
16 weeks	31.3(26.9 to 40.2)

Serum TNF-a Receptor 1 Levels at Baseline and 16 Weekspg/ml · baseline and 16 weeks · mean

Measure	Bydureon Treatmentn=6
baseline	392(311 to 514)
16 weeks	399(332 to 535)

Serum Soluble CD14 Levels at Baseline and 16 Weekspg/ml · baseline and 16 weeks · mean

Measure	Bydureon Treatmentn=6
baseline	598(458 to 802)
16 weeks	671(562 to 805)

Serum TNF-a Receptor 2 Levels at Baseline and 16 Weekspg/ml · baseline and 16 weeks · mean

Measure	Bydureon Treatmentn=6
baseline	598(458 to 802)
16 weeks	671(562 to 805)

Serum Hemoglobin A1c (HbA1c) Levels at Baseline and 16 Weekspercentage of glycated haemoglobin · baseline and 16 weeks · mean

Measure	Bydureon Treatmentn=6
baseline	7.6(7.2 to 8.0)
16 weeks	6.3(6.0 to 7.7)

Serum Triglycerides Levels at Baseline and 16 Weeksmg/dL · baseline and 16 weeks · mean

Measure	Bydureon Treatmentn=6
baseline	172(100 to 245)
16 weeks	118(110 to 189)

Serum Total Cholesterol Levels at Baseline and 16 Weeksmg/dL · baseline and 16 weeks · mean

Measure	Bydureon Treatmentn=6
baseline	192(158 to 220)
16 weeks	176(146 to 211)

The trial

How NCT01791465 was run

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.

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

Who could join the trial

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)

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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