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CompletedPhase 4Results posted

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)

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

NCT IDNCT01006889
Org study IDHSC20060167-2

Timeline

Milestones

Study first posted2009-11-03estimated
Results first posted2016-07-29estimated
Last update posted2016-09-28estimated
Study start2008-01 (month precision)
Primary completion2009-12actual (month precision)
Study completion2010-02actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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

Glycemic / diabetes
3
Weight & body composition
2
MASH / liver
1
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change in Anthropometric Variables (Weight).

Time frame:6 months

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), Kg95% CI
Exenatide (Twice Daily)-4.7
Secondary/protocol endpoint

Change in Anthropometric Variables (BMI).

Time frame:6 months

BMI, change

change from baseline, improvement

Posted result

GroupValue (mean), Kg/m295% CI
Exenatide (Twice Daily)-1.5

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

A1c

Time frame:6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), percentage of A1c95% CI
Exenatide (Twice Daily)6.8
Secondary/protocol endpoint

Insulin Secretion (Hyperglycemic Clamp)

Time frame:6 months

C-peptide AUC

change from baseline, improvement

Posted result

GroupValue (mean), ng/ml95% CI
Exenatide (Twice Daily)Delta first phase insulin secretion-0.1
Delta second phase insulin secretion1.1
Secondary/protocol endpoint

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

GroupValue (mean), percentage change vs pretreatment95% CI
Exenatide (Twice Daily)30

MASH / liver

1 endpoint
Primary/protocol endpoint

Hepatic Steatosis

Time frame:6 months

Liver fat content, change

change from baseline, improvement

Posted result

GroupValue (mean), Percentage of liver fat95% CI
Exenatide (Twice Daily)4.0

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Lipid Profiles, Lipoprotein Analysis by NMR (LipoScience).

Time frame:6 months

change from baseline, improvement

Posted result

GroupValue (mean), mg/dl95% CI
Exenatide (Twice Daily)Cholesterol-4
Triglyceride21
LDL-C-8
HDL-C-1

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number of Severe Hypoglycemic (Glucose ≤40 mg/dL) Events.

Time frame:6 months

Severe hypoglycemia

event count, event

Posted result

GroupValue (number), number of events95% CI
Exenatide (Twice Daily)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.