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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
Lead sponsor
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 Content•Liver 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsMyocardial Fat Content
Time frame:6 months
change from baseline, improvement
Posted result
| Group | Value (mean), percentage of myocardium content | 95% CI |
|---|---|---|
| Exenatide | 1.7 | — |
| Glipizide | 1.1 | — |
Left Ventricular Ejection Fraction (LVEF)(%).
Time frame:6 months
LVEF
change from baseline, improvement
Posted result
| Group | Value (mean), percent of Left ventricular function | 95% CI |
|---|---|---|
| Exenatide | 60 | — |
| Glipizide | 56 | — |
MASH / liver
1 endpointHepatic Fat Content
Time frame:6 months
Liver fat content, change
change from baseline, improvement
Posted result
| Group | Value (mean), percent of hepatic fat | 95% CI |
|---|---|---|
| Exenatide | 10.9 | — |
| Glipizide | 13.1 | — |
Cardiometabolic biomarkers
1 endpointMonocyte Inflammatory Protein Nuclear Factor Kappa-B (NFkappaB) (%)
Time frame:6 months
percent change from baseline, improvement
Posted result
| Group | Value (mean), percentage change from baseline | 95% CI |
|---|---|---|
| Exenatide | -65.0 | — |
| Glipizide | 0.0 | — |
Provenance
Sources
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.