Trial Outcomes & Findings for Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults (NCT NCT01791465)

Results Overview

The primary outcome will be the change in hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

baseline and 16 weeks

Results posted on

2017-03-10

Participant Flow

Six HIV-infected participants recruited from the Vanderbilt Comprehensive Care Clinic between April 17, 2013 and May 6, 2016.

No consented participants were excluded prior to group assignment

Participant milestones

Participant milestones
Measure	Bydureon Treatment Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide
Age, Continuous	51 years n=39 Participants
Sex: Female, Male Female	2 Participants n=39 Participants
Sex: Female, Male Male	4 Participants n=39 Participants
Region of Enrollment United States	6 participants n=39 Participants

PRIMARY outcome

Timeframe: baseline and 16 weeks

Population: Change in hsCRP over 16 weeks of treatment

The primary outcome will be the change in hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks baseline	4.0 mg/dl Interval 2.0 to 14.9
Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks 16 weeks	5.6 mg/dl Interval 2.4 to 20.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Serum Interleukin 6 (IL-6) at Levels at Baseline and 16 Weeks baseline	1.07 mg/dl Interval 0.68 to 3.01
Serum Interleukin 6 (IL-6) at Levels at Baseline and 16 Weeks week 16	1.27 mg/dl Interval 0.62 to 3.09

SECONDARY outcome

Timeframe: baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weeks baseline	2.44 pg/ml Interval 1.73 to 3.74
Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weeks 16 weeks	2.82 pg/ml Interval 2.4 to 3.9

SECONDARY outcome

Timeframe: baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weeks baseline	5.73 pg/ml Interval 3.39 to 9.31
Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weeks 16 weeks	4.78 pg/ml Interval 2.93 to 12.3

SECONDARY outcome

Timeframe: baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at Baseline and 16 Weeks baseline	0.088 pg/ml Interval 0.074 to 0.115
Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at Baseline and 16 Weeks 16 weeks	0.081 pg/ml Interval 0.046 to 0.132

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Oral Glucose Insulin Sensitivity (OGIS) at Baseline and 16 Weeks baseline	310 ml/min/m^2 BSA Interval 293.0 to 369.0
Oral Glucose Insulin Sensitivity (OGIS) at Baseline and 16 Weeks 16 weeks	399 ml/min/m^2 BSA Interval 314.0 to 480.0

SECONDARY outcome

Timeframe: baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Serum Adipokine Leptin Levels at Baseline and 16 Weeks baseline	17.4 ng/ml Interval 10.3 to 84.6
Serum Adipokine Leptin Levels at Baseline and 16 Weeks 16 weeks	14.3 ng/ml Interval 10.0 to 77.6

SECONDARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Body Mass Index at Baseline and 16 Weeks baseline	32.6 kg/m2 Interval 28.5 to 43.4
Body Mass Index at Baseline and 16 Weeks 16 weeks	31.3 kg/m2 Interval 26.9 to 40.2

SECONDARY outcome

Timeframe: baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Serum TNF-a Receptor 1 Levels at Baseline and 16 Weeks baseline	392 pg/ml Interval 311.0 to 514.0
Serum TNF-a Receptor 1 Levels at Baseline and 16 Weeks 16 weeks	399 pg/ml Interval 332.0 to 535.0

SECONDARY outcome

Timeframe: baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Serum Soluble CD14 Levels at Baseline and 16 Weeks baseline	598 pg/ml Interval 458.0 to 802.0
Serum Soluble CD14 Levels at Baseline and 16 Weeks 16 weeks	671 pg/ml Interval 562.0 to 805.0

SECONDARY outcome

Timeframe: baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Serum TNF-a Receptor 2 Levels at Baseline and 16 Weeks baseline	598 pg/ml Interval 458.0 to 802.0
Serum TNF-a Receptor 2 Levels at Baseline and 16 Weeks 16 weeks	671 pg/ml Interval 562.0 to 805.0

SECONDARY outcome

Timeframe: baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Serum Hemoglobin A1c (HbA1c) Levels at Baseline and 16 Weeks baseline	7.6 percentage of glycated haemoglobin Interval 7.2 to 8.0
Serum Hemoglobin A1c (HbA1c) Levels at Baseline and 16 Weeks 16 weeks	6.3 percentage of glycated haemoglobin Interval 6.0 to 7.7

SECONDARY outcome

Timeframe: baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Serum Triglycerides Levels at Baseline and 16 Weeks baseline	172 mg/dL Interval 100.0 to 245.0
Serum Triglycerides Levels at Baseline and 16 Weeks 16 weeks	118 mg/dL Interval 110.0 to 189.0

SECONDARY outcome

Timeframe: baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Serum Total Cholesterol Levels at Baseline and 16 Weeks baseline	192 mg/dL Interval 158.0 to 220.0
Serum Total Cholesterol Levels at Baseline and 16 Weeks 16 weeks	176 mg/dL Interval 146.0 to 211.0

SECONDARY outcome

Timeframe: baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Serum HDL Cholesterol Levels at Baseline and 16 Weeks baseline	39 mg/dL Interval 35.0 to 45.0
Serum HDL Cholesterol Levels at Baseline and 16 Weeks 16 weeks	34 mg/dL Interval 31.0 to 47.0

SECONDARY outcome

Timeframe: baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Serum LDL Cholesterol Levels at Baseline and 16 Weeks baseline	127 mg/dL Interval 91.0 to 134.0
Serum LDL Cholesterol Levels at Baseline and 16 Weeks 16 weeks	109 mg/dL Interval 80.0 to 145.0

SECONDARY outcome

Timeframe: baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Body Weight at Baseline and 16 Weeks baseline	100 kilograms Interval 87.0 to 112.0
Body Weight at Baseline and 16 Weeks 16 weeks	96 kilograms Interval 81.0 to 111.0

SECONDARY outcome

Timeframe: baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Waist Circumference at Baseline and 16 Weeks baseline	113 centimeters Interval 105.0 to 134.0
Waist Circumference at Baseline and 16 Weeks 16 weeks	113 centimeters Interval 102.0 to 132.0

SECONDARY outcome

Timeframe: baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Hip Circumference at Baseline and 16 Weeks baseline	107 centimeters Interval 102.0 to 125.0
Hip Circumference at Baseline and 16 Weeks 16 weeks	103 centimeters Interval 97.0 to 117.0

SECONDARY outcome

Timeframe: baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
Waist to Hip Ratio at Baseline and 16 Weeks baseline	1.06 ratio Interval 1.03 to 1.07
Waist to Hip Ratio at Baseline and 16 Weeks 16 weeks	1.06 ratio Interval 1.05 to 1.12

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 16 weeks

Normal: LnRHI \> 0.51 Abnormal: LnRHI ≤ 0.51

Outcome measures

Outcome measures
Measure	Bydureon Treatment n=6 Participants Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
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	0.71 units on a scale Interval 0.42 to 0.93
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 16 weeks	0.62 units on a scale Interval 0.59 to 0.77

Adverse Events

Bydureon Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bydureon Treatment n=6 participants at risk Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
General disorders Fatigue and weakness	33.3% 2/6 • Number of events 2

Additional Information

John Koethe MD

Vanderbilt University Medical Center

Phone: 615-343-0533

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place