GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT00701935

TerminatedPhase 2Results posted

Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 27-40•HbA1c 7-8.9%

Primary endpoint

•Visceral fat, 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 IDNCT00701935

Org study IDH8O-CA-GWCE

Timeline

Milestones

Study first posted2008-06-19estimated

Results first posted2013-02-13estimated

Last update posted2015-04-10estimated

Study start2008-08 (month precision)

Primary completion2012-01actual (month precision)

Study completion2012-01actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients between 18 and 85 years of age, inclusive.

•Patients with type 2 diabetes

•Patients have been treated with metformin, at a stable dose for at least 3 months prior to Visit 1

•Patients have HbA1c of 7.0% to 8.9%, inclusive.

•Patients have a body mass index >27 kg/m2 and <40 kg/m2 and meet local CT scan body weight requirements. For South Asian, Japanese, and Chinese patients, a body mass index >=25 kg/m2 is acceptable as the lower limit.

•Patients have a history of stable body weight (not varying by >2 kg in the 3 months prior to Visit 1).

•Medications for the treatment of high blood pressure are stable with respect to treatment regimen for 4 weeks prior to Visit 1.

•Stable regimen of lipid-lowering agents for 6 weeks prior to Visit 1.

Exclusion criteria

•Have received treatment in the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

•Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.

•Have a history of renal transplantation, or are currently receiving renal dialysis.

•Have had a clinically significant history of cardiac disease or presence of active cardiac disease within 1 year prior to Visit 1, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.

•Have known hemoglobinopathy or clinically significant, chronic anemia.

•Known or are likely to become transfusion dependent during the study.

•Have active, symptomatic proliferative retinopathy.

•Are receiving chronic treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility. (i.e. metoclopramide, cisapride, and chronic use of macrolide antibiotics)

•Have severe gastrointestinal disease, including gastroparesis.

•Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 months immediately prior to Visit 1.

•Have taken exenatide, liraglutide or any other GLP-1 receptor agonist in the past 6 months, either in a clinical study or as commercially available medication. Patients with known allergy to exenatide should be excluded.

•Have used any prescription or over the counter drug to promote weight loss within 3 months prior to Visit 1, or intend to use such a drug during the study. (Examples: Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Acomplia [rimonabant]).

•Have participated in a structured weight loss program within 3 months prior to Visit 1, or intend to participate in such a plan during this study.

•Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to Visit 1: Insulin; Thiazolidinediones; Alpha-glucosidase inhibitors; Sulfonylureas; Oral DPP-IV inhibitors; Meglitinides.

•Are taking warfarin, or a coumarol derivative.

Endpoints (13)

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

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

4 endpoints

Primary/protocol endpoint

Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months

Time frame:baseline, 6 months

Visceral fat, change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), % change	95% CI
Exenatide BID	-5.28	—
Placebo	-4.30	—

Mean Difference (Final Values)-0.9895% CI-9.92 – 7.95p0.8252ANCOVA

Secondary/protocol endpoint

Percentage Change in Total Abdominal Fat From Baseline to 6 Months

Time frame:baseline, 6 months

Total fat mass

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), % change	95% CI
Exenatide BID	-5.81	—
Placebo	-3.74	—

Mean Difference (Final Values)-2.0795% CI-8.53 – 4.39p0.5207ANCOVA

Secondary/protocol endpoint

Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months

Time frame:baseline, 6 months

Subcutaneous fat, change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), % change	95% CI
Exenatide BID	-7.27	—
Placebo	-3.56	—

Mean Difference (Final Values)-3.7195% CI-9.15 – 1.73p0.1755ANCOVA

Secondary/protocol endpoint

Change in Weight From Baseline to 6 Months

Time frame:baseline, 6 months

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Exenatide BID	-2.54	—
Placebo	-0.33	—

Mean Difference (Final Values)-2.2195% CI-3.66 – -0.76p0.0035ANCOVA

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Change in HbA1c From Baseline to 6 Months

Time frame:baseline, 6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), % change	95% CI
Exenatide BID	-0.69	—
Placebo	0.19	—

Mean Difference (Final Values)-0.8895% CI-1.19 – -0.57p<0.0001ANCOVA

Secondary/protocol endpoint

Percentage of Patients With HbA1c <=7.0% at 6 Months

Time frame:6 months

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of patients	95% CI
Exenatide BID	60.7	—
Placebo	21.4	—

Secondary/protocol endpoint

Change in Fasting Plasma Glucose From Baseline to 6 Months

Time frame:baseline, 6 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide BID	-1.47	—
Placebo	-0.08	—

Mean Difference (Final Values)-1.3995% CI-2.38 – -0.40p0.0073ANCOVA

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

Change in Systolic Blood Pressure From Baseline to 6 Months

Time frame:baseline, 6 months

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Exenatide BID	-7.48	—
Placebo	1.79	—

Secondary/protocol endpoint

Change in Diastolic Blood Pressure From Baseline to 6 Months

Time frame:baseline, 6 months

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), mmHg	95% CI
Exenatide BID	-2.86	—
Placebo	-0.18	—

Secondary/protocol endpoint

Change in Total Cholesterol From Baseline to 6 Months

Time frame:baseline, 6 months

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide BID	-0.06	—
Placebo	0.14	—

Mean Difference (Final Values)-0.2095% CI-0.71 – 0.30p0.4145ANCOVA

Secondary/protocol endpoint

Change in Triglycerides From Baseline to 6 Months

Time frame:baseline, 6 months

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide BID	-0.17	—
Placebo	0.06	—

Mean Difference (Final Values)-0.2495% CI-0.80 – 0.33p0.4007ANCOVA

Secondary/protocol endpoint

Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months

Time frame:baseline, 6 months

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide BID	0.06	—
Placebo	0.04	—

Mean Difference (Final Values)0.0195% CI-0.08 – 0.11p0.7915ANCOVA

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event

Time frame:baseline, 6 months

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), hypoglycemia rate/year	95% CI
Exenatide BID	0.41	—
Placebo	0.12	—

Ratio3.2895% CI0.68 – 15.77p0.1388Regression, Linear

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.