CompletedPhase 4Results posted

The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes

Exenatide and Postprandial Endothelial Dysfunction: Effects and Mechanisms

Lead sponsor

Carl T. Hayden VA Medical Center

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Prediabetes / glucose intolerance, Type 2 diabetes

Eligibility highlights

•HbA1c ≤8%

Primary endpoint

•Reactive Hyperemia Index (RHI)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01181986

Org study ID1-10-CT-31

Timeline

Milestones

Study first posted2010-08-16estimated

Results first posted2014-04-28estimated

Last update posted2014-05-20estimated

Study start2010-08 (month precision)

Primary completion2012-12actual (month precision)

Study completion2012-12actual (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Prediabetes / glucose intoleranceType 2 diabetes

Who can enroll

Minimum age35 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•US Veterans

•type 2 diabetes mellitus (T2D) diagnosed within 3 years with good glycemic control on diet, metformin, or sulfonylurea agents or combinations of these agents (HbA1c ≤8.0%)

•T2D diagnosed ≥ 5 years prior to study enrollment

•Impaired glucose tolerance

Exclusion criteria

•T2D not meeting inclusion above criteria for duration of diabetes or HbA1c values

•known or suspected T1D (early onset age, low body mass index, lack of family history)

•TZD use in the prior 3 months

•prior regular use of insulin

•Creatinine >2.0 mg/dl or other laboratory or clinical evidence of kidney disease

•anemia

•known active liver disease or hepatic enzyme elevation two-and-a half times above normal

•acute bacterial or viral illness or evidence of other active infection in the past 4 weeks

•stable or unstable angina or other major illness in the past 6 months

•Raynaud's disease or any rheumatic disease affecting fingers

•current regular use of anti-inflammatory medications or antioxidants, including over the counter medications and high dose salicylates (>1 g/day);

•subjects receiving lipid lowering or anti-hypertension medications must be on stable doses for at least 2 months prior to participation.

Endpoints (3)

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

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Plasma Glucose

Time frame:0, 2, 4, 6, and 8 hours post-study drug on day 11

Postprandial glucose

descriptive, improvement

Posted result

Group	Least-squares mean · mg/dl	95% CI
Exenatide (Sub-study 1)	115	-
Placebo (Sub-study 1)	136	-

p<0.0001ANCOVA

Cardiometabolic biomarkers

2 endpoints

Primary/protocol endpoint

Reactive Hyperemia Index (RHI)

Time frame:0, 2, 4, 6 and 8 hours on Day 11 (Sub-study 1); 0 and 120 minutes on test Days 1, 2 & 3 (Sub-study 2)

ratio, improvement

Posted result

Group	Least-squares mean · ratio	95% CI
Exenatide (Subs-study 1)	1.90	-
Placebo (Sub-study 1)	1.79	-
Saline+Exenatide (Sub-study 2)	2.24	-
Saline+Placebo (Sub-study 2)	1.95	-
Exendin-9+Exenatide (Sub-study 2)	1.99	-

p<0.0001ANCOVA

p0.006ANCOVA

p0.003ANCOVA

Secondary/protocol endpoint

Plasma Triglycerides

Time frame:0, 2, 4, 6 and 8 hours post-study drug on day 11

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Least-squares mean · mg/dl	95% CI
Exenatide (Sub-study 1)	175	-
Placebo (Sub-study 1)	230	-

p<0.0001ANCOVA

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.