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Adding Exenatide to Insulin Therapy for Patients With Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease
A New Treatment Strategy of Adding Exenatide to Insulin Therapy for Patients With Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease (NAFLD)
Lead sponsor
Asset
Exenatide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
24
actual
Study population
MASH / NAFLD / liver fibrosis, 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
To enter the study subjects must meet the following criteria:
1. Have been on intensified insulin therapy with insulin detemir (Levemir) and premeal insulin aspart (Novolog®) for the previous 6 months.
2. Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent.
3. Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients who have undergone a hysterectomy are eligible for participation in the study. Female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period.
4. Age range of 18 to 70 years (inclusive).
5. Patients must have been on a stable dose of allowed chronic medications for 6 months prior to entering the double-blind treatment period.
6. All participants must have the following laboratory values:
Hemoglobin ≥12 g/dl in males or ≥11 g/dl in females Serum creatinine ≤1.5 mg/dl AST (SGOT) and ALT (SGPT) ≤2.5 times upper limit of normal Alkaline phosphatase ≤2.5 times upper limit of normal
Exclusion criteria
Patients will be excluded if any of the following criteria are present:
1. Individuals with type 1 diabetes or type 2 diabetes and a FPG ≥ 300 mg/dl; poor compliance with insulin therapy.
2. Subjects on sulfonylureas, metformin and/or TZDs unless the dose has been stable for at least 6 months prior to study entry.
3. Patients on any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on stable doses of such agents for the past two months before entry into the study. Patients may be taking stable doses of estrogens or other hormonal replacement therapy if the patient has been on these agents for the prior two months. Patients taking systemic glucocorticoids will be excluded.
4. Past (within 1 year) or current history of alcohol abuse.
5. Patients will be excluded if there is a history of clinically significant heart disease (New York Heart Classification greater than grade II), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) or chronic renal failure (serum creatinine greater than 1.5 mg/dl).
Endpoints (8)
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
Weight & body composition
2 endpointsChange in Anthropometric Variables (Weight).
Time frame:6 months
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), Kg | 95% CI |
|---|---|---|
| Exenatide (Twice Daily) | -4.7 | — |
Change in Anthropometric Variables (BMI).
Time frame:6 months
BMI, change
change from baseline, improvement
Posted result
| Group | Value (mean), Kg/m2 | 95% CI |
|---|---|---|
| Exenatide (Twice Daily) | -1.5 | — |
Glycemic / diabetes
3 endpointsA1c
Time frame:6 months
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), percentage of A1c | 95% CI |
|---|---|---|
| Exenatide (Twice Daily) | 6.8 | — |
Insulin Secretion (Hyperglycemic Clamp)
Time frame:6 months
C-peptide AUC
change from baseline, improvement
Posted result
| Group | Value (mean), ng/ml | 95% CI |
|---|---|---|
| Exenatide (Twice Daily)Delta first phase insulin secretion | -0.1 | — |
| Delta second phase insulin secretion | 1.1 | — |
Percent Change From Baseline in Glucose Infusion (M Value) During Hyperglycemic Clamp
Time frame:6 months
HOMA-IR (insulin sensitivity)
percent change from baseline, improvement
Posted result
| Group | Value (mean), percentage change vs pretreatment | 95% CI |
|---|---|---|
| Exenatide (Twice Daily) | 30 | — |
MASH / liver
1 endpointHepatic Steatosis
Time frame:6 months
Liver fat content, change
change from baseline, improvement
Posted result
| Group | Value (mean), Percentage of liver fat | 95% CI |
|---|---|---|
| Exenatide (Twice Daily) | 4.0 | — |
Cardiometabolic biomarkers
1 endpointLipid Profiles, Lipoprotein Analysis by NMR (LipoScience).
Time frame:6 months
change from baseline, improvement
Posted result
| Group | Value (mean), mg/dl | 95% CI |
|---|---|---|
| Exenatide (Twice Daily)Cholesterol | -4 | — |
| Triglyceride | 21 | — |
| LDL-C | -8 | — |
| HDL-C | -1 | — |
Safety / tolerability / PK
1 endpointNumber of Severe Hypoglycemic (Glucose ≤40 mg/dL) Events.
Time frame:6 months
Severe hypoglycemia
event count, event
Posted result
| Group | Value (number), number of events | 95% CI |
|---|---|---|
| Exenatide (Twice Daily) | 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.