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

• Sponsor: Vanderbilt University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01791465
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 21
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus Infection; Diabetes Mellitus	Drug: extended-release exenatide	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study of Extended-release Exenatide to Improve Glucose Control and Reduce Systemic Inflammation in Diabetic, HIV-infected Adults on Antiretroviral Therapy
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bydureon treatment Treatment for 16 weeks with extended-release Exenatide (Bydureon)	Drug: extended-release exenatide; Single arm study - 2mg Bydureon every 7 days x 16 weeks; Other Names: Bydureon

Outcome Measures

Primary Outcome Measures

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

   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 [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.

Secondary Outcome Measures

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

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

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

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

5. Serum Adipokine Leptin Levels at Baseline and 16 Weeks [baseline and 16 weeks]

6. Body Mass Index at Baseline and 16 Weeks [16 weeks]

7. Serum TNF-a Receptor 1 Levels at Baseline and 16 Weeks [baseline and 16 weeks]

8. Serum Soluble CD14 Levels at Baseline and 16 Weeks [baseline and 16 weeks]

9. Serum TNF-a Receptor 2 Levels at Baseline and 16 Weeks [baseline and 16 weeks]

10. Serum Hemoglobin A1c (HbA1c) Levels at Baseline and 16 Weeks [baseline and 16 weeks]

11. Serum Triglycerides Levels at Baseline and 16 Weeks [baseline and 16 weeks]

12. Serum Total Cholesterol Levels at Baseline and 16 Weeks [baseline and 16 weeks]

13. Serum HDL Cholesterol Levels at Baseline and 16 Weeks [baseline and 16 weeks]

14. Serum LDL Cholesterol Levels at Baseline and 16 Weeks [baseline and 16 weeks]

15. Body Weight at Baseline and 16 Weeks [baseline and 16 weeks]

16. Waist Circumference at Baseline and 16 Weeks [baseline and 16 weeks]

17. Hip Circumference at Baseline and 16 Weeks [baseline and 16 weeks]

18. Waist to Hip Ratio at Baseline and 16 Weeks [baseline and 16 weeks]

Other Outcome Measures

1. 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 [baseline and 16 weeks]

   Normal: LnRHI > 0.51 Abnormal: LnRHI ≤ 0.51

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University	Nashville	Tennessee	United States	37240

Sponsors and Collaborators

• Vanderbilt University
• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: John Koethe, MD, Vanderbilt University School of Medicine
• Principal Investigator: C. William Wester, MD, Vanderbilt University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John R. Koethe, Assistant Professor of Medicine, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT01791465
• Other Study ID Numbers: 121342; P30AI054999
• First Posted: Feb 15, 2013
• Last Update Posted: Mar 10, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by John R. Koethe, Assistant Professor of Medicine, Vanderbilt University: HIV; Diabetes
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Exenatide

Study Results

Participant Flow

Recruitment Details	Six HIV-infected participants recruited from the Vanderbilt Comprehensive Care Clinic between April 17, 2013 and May 6, 2016.
Pre-assignment Detail	No consented participants were excluded prior to group assignment

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Period Title: Overall Study
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide
Overall Participants	6
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	51
Sex: Female, Male (Count of Participants)
Female	2 33.3%
Male	4 66.7%
Region of Enrollment (participants) [Number]
United States	6 100%

Outcome Measures

1. Primary Outcome

Title	Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks
Description	The primary outcome will be the change in hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

Change in hsCRP over 16 weeks of treatment

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	4.0
16 weeks	5.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Primary Outcome

Title	Serum Interleukin 6 (IL-6) at Levels at Baseline and 16 Weeks
Description	The primary outcome will be the change in serum IL-6 levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	1.07
week 16	1.27

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments	The null hypothesis was that there would be no difference between baseline and 16 week IL-6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.34
	Comments	Unadjusted - this was a Wilcoxon signed rank p-value (Baseline vs. week 16) comparison
	Method	Wilcoxon (Mann-Whitney)
	Comments	no adjustments

3. Secondary Outcome

Title	Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weeks
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide: Single arm study - 2mg Bydureon every 7 days x 16 weeks
Measure Participants	6
baseline	2.44
16 weeks	2.82

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.046
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weeks
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	5.73
16 weeks	4.78

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.92
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

Title	Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at Baseline and 16 Weeks
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	0.088
16 weeks	0.081

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.69
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Secondary Outcome

Title	Oral Glucose Insulin Sensitivity (OGIS) at Baseline and 16 Weeks
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.
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	310
16 weeks	399

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.47
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Secondary Outcome

Title	Serum Adipokine Leptin Levels at Baseline and 16 Weeks
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	17.4
16 weeks	14.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.92
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

8. Secondary Outcome

Title	Body Mass Index at Baseline and 16 Weeks
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	32.6
16 weeks	31.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

9. Secondary Outcome

Title	Serum TNF-a Receptor 1 Levels at Baseline and 16 Weeks
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	392
16 weeks	399

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.60
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

10. Secondary Outcome

Title	Serum Soluble CD14 Levels at Baseline and 16 Weeks
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	598
16 weeks	671

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

11. Secondary Outcome

Title	Serum TNF-a Receptor 2 Levels at Baseline and 16 Weeks
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	598
16 weeks	671

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

12. Secondary Outcome

Title	Serum Hemoglobin A1c (HbA1c) Levels at Baseline and 16 Weeks
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	7.6
16 weeks	6.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

13. Secondary Outcome

Title	Serum Triglycerides Levels at Baseline and 16 Weeks
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	172
16 weeks	118

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.69
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

14. Secondary Outcome

Title	Serum Total Cholesterol Levels at Baseline and 16 Weeks
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	192
16 weeks	176

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.50
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

15. Secondary Outcome

Title	Serum HDL Cholesterol Levels at Baseline and 16 Weeks
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	39
16 weeks	34

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.42
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

16. Secondary Outcome

Title	Serum LDL Cholesterol Levels at Baseline and 16 Weeks
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	127
16 weeks	109

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.89
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

17. Other Pre-specified Outcome

Title	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
Description	Normal: LnRHI > 0.51 Abnormal: LnRHI ≤ 0.51
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	0.71
16 weeks	0.62

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.75
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

18. Secondary Outcome

Title	Body Weight at Baseline and 16 Weeks
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	100
16 weeks	96

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.046
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

19. Secondary Outcome

Title	Waist Circumference at Baseline and 16 Weeks
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	113
16 weeks	113

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

20. Secondary Outcome

Title	Hip Circumference at Baseline and 16 Weeks
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	107
16 weeks	103

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.12
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

21. Secondary Outcome

Title	Waist to Hip Ratio at Baseline and 16 Weeks
Time Frame	baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Measure Participants	6
baseline	1.06
16 weeks	1.06

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bydureon Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.046
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Arm/Group Title	Bydureon Treatment
Arm/Group Description	Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
All Cause Mortality
	Bydureon Treatment
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Bydureon Treatment
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Other (Not Including Serious) Adverse Events
	Bydureon Treatment
	Affected / at Risk (%)	# Events
Total	2/6 (33.3%)
General disorders
Fatigue and weakness	2/6 (33.3%)	2

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.