← Trials/Trial dossier/NCT01432405

CompletedPhase 4Results posted

Effect Of Exenatide Treatment on Liver Fat Content in Patients With Diabetes

Effect of Exenatide Treatment on Hepatic Fat Content and Plasma Adipocytokine Levels 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 endpoint

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

NCT IDNCT01432405
Org study IDH-21068

Timeline

Milestones

Study first posted2011-09-13estimated
Last update posted2016-04-12estimated
Results first posted2016-04-12estimated
Study start2007-06 (month precision)
Primary completion2008-07actual (month precision)
Study completion2009-06actual (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 range in age from 30 to 70 years.

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

3. 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 or be surgically sterilized.

4. Patients must meet the American Diabetes Association Criteria for diagnosis of type 2 diabetes mellitus.

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

6. Patients must have Hematocrit greater than 34%.

7. Subjects whose body weight has been stable (±1 Kg) over the three months prior to study will be included.

Exclusion criteria

1, Type 1 diabetes.

2. 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 (CHF), or clinically significant cardiac, liver or kidney disease (creatinine greater than 1.8 mg/dl).

Endpoints (2)

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

MASH / liver
1
Cardiometabolic biomarkers
1

MASH / liver

1 endpoint
Primary/protocol endpoint

Hepatic Fat

Time frame:one year

Liver fat content, change

change from baseline, improvement

Posted result

GroupValue (mean), percent of liver fat95% CI
Pioglitazone and Exenatide4.7
Pioglitazone6.5

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Plasma Adipocytokines

Time frame:one year

Adiponectin, change

change from baseline, improvement

Posted result

GroupValue (mean), microgram per ml95% CI
Pioglitazone and Exenatide23.2
Pioglitazone15.8

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.