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CompletedPhase 4Results posted

Effect of Exenatide on Liver and Heart Fat and Inflammation

Effect of Exenatide Treatment on Myocardial Fat Content, Left Ventricular Function, and Vascular Inflammation in Patients With Type 2 Diabetes Mellitus

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

24

actual

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoints

Myocardial Fat ContentLiver fat content, change

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 IDNCT01951651
Org study IDH-26030

Timeline

Milestones

Study first posted2013-09-26estimated
Results first posted2016-04-15estimated
Last update posted2016-05-16estimated
Study start2010-04 (month precision)
Primary completion2012-10actual (month precision)
Study completion2013-03actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.

2. Patients may be of either sex. Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions.

3. Patients must range in age from 30 to 70 years, inclusive.

4. Patients must meet the American Diabetes Association (ADA) criteria (ADA 1997 Criteria: fasting plasma glucose greater than or equal to 126 mg/dl) for the diagnosis of type 2 diabetes mellitus.

5. Patients must be on diet therapy and/or metformin treatment for type 2 diabetes (stable dose)and have a fasting plasma glucose concentration between 126 and 260 mg/dl

6. Patients must have Hematocrit greater than 34 vol%.

7. Subjects whose body weight has been stable over the three months prior to study enrollment will be included.

Exclusion criteria

1. Patients must not have type 1 diabetes.

2. Patients must not have a fasting plasma glucose greater than 260 mg/dl.

3. Patients must not have received a thiazolidinedione for at least 3 months prior to randomization.

4. Patients must not be on insulin treatment or have received insulin for more than one week within the previous year prior to entry. Patients should not be on sulfonylureas, sitagliptin, or exenatide treatment.

5. Patients taking systemic glucocorticoids or other medications known to affect glucose tolerance are excluded.

6. Patients taking medications that affect gastrointestinal motility will be excluded.

7. Patients with a history of Congestive Heart Failure, or clinically significant cardiac, liver or kidney disease (creatinine greater than 1.5 mg/dl).

Endpoints (4)

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

Cardiovascular outcomes
2
MASH / liver
1
Cardiometabolic biomarkers
1

Cardiovascular outcomes

2 endpoints
Primary/protocol endpoint

Myocardial Fat Content

Time frame:6 months

change from baseline, improvement

Posted result

GroupValue (mean), percentage of myocardium content95% CI
Exenatide1.7
Glipizide1.1
Secondary/protocol endpoint

Left Ventricular Ejection Fraction (LVEF)(%).

Time frame:6 months

LVEF

change from baseline, improvement

Posted result

GroupValue (mean), percent of Left ventricular function95% CI
Exenatide60
Glipizide56

MASH / liver

1 endpoint
Primary/protocol endpoint

Hepatic Fat Content

Time frame:6 months

Liver fat content, change

change from baseline, improvement

Posted result

GroupValue (mean), percent of hepatic fat95% CI
Exenatide10.9
Glipizide13.1

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Monocyte Inflammatory Protein Nuclear Factor Kappa-B (NFkappaB) (%)

Time frame:6 months

percent change from baseline, improvement

Posted result

GroupValue (mean), percentage change from baseline95% CI
Exenatide-65.0
Glipizide0.0

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.