CompletedPhase 3Results posted

Effect on Weight Loss of Exenatide Versus Placebo

Effect on Weight Loss of Exenatide Versus Placebo in Subjects With Type 2 Diabetes Participating in a Lifestyle Modification Program

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

196

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI 25-39.9•HbA1c 6.6-10%

Primary endpoint

•Body weight, absolute change (kg)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00375492

Org study IDH8O-US-GWBM

Timeline

Milestones

Study first posted2006-09-13estimated

Results first posted2009-09-04estimated

Last update posted2015-04-07estimated

Study start2006-09 (month precision)

Primary completion2008-02actual (month precision)

Study completion2008-02actual (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with type 2 diabetes for at least 6 months

•Have been treated with a stable dose of the following for at least 6 weeks prior to screening: *immediate or extended release metformin, or *a sulfonylurea, or *a fixed-dose sulfonylurea/metformin combination therapy

•Have an HbA1c of 6.6% to 10.0%, inclusive

•Have a Body Mass Index (BMI) of 25 kg/m^2 to 39.9 kg/m^2, inclusive

Exclusion criteria

•Are treated with any of the following excluded medications: *exogenous insulin, thiazolidinedione, or alpha-glucosidase inhibitor for more than 1 week within 6 weeks of screening; *Symlin injection at any time; * Byetta injection within 3 months of screening or discontinuation of therapy at any time due to adverse reaction; *drugs that directly affect gastrointestinal motility; *use of a weight loss drug (including those available over the counter) within 3 months of screening; *chronic (lasting longer than 2 weeks) systemic corticosteroids (excluding topical, intranasal, and inhaled preparations) by oral, intravenous, or intramuscular route within 2 months of screening

•Have conditions contraindicating metformin and/or sulfonylurea use

•Have had a change in lipid-lowering agents within 6 weeks of screening

•Have received glucagon-like peptide-1 (GLP-1) analogs, or dipeptidyl peptidase-IV inhibitors (DPP-IV inhibitors) or have previously participated in this study

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

Endpoints (12)

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

Cardiometabolic biomarkers

Weight & body composition

Safety / tolerability / PK

Weight & body composition

2 endpoints

Primary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Least-squares mean · kg	95% CI
Group A (Exenatide)	-6.16	-
Group B (Placebo)	-3.97	-

p0.0030Mixed Model Repeated Measures

Secondary/protocol endpoint

Change From Baseline in Waist Circumference at Week 24

Time frame:baseline, Week 24

Waist circumference, change

change from baseline, improvement

Posted result

Group	Least-squares mean · cm	95% CI
Group A (Exenatide)	-5.33	-
Group B (Placebo)	-4.18	-

p0.1985Mixed Model Repeated Measures

Glycemic / diabetes

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

Time frame:baseline, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · percent hemoglobin	95% CI
Group A (Exenatide)	-1.21	-
Group B (Placebo)	-0.73	-

p<0.0001Mixed Model Repeated Measures

Secondary/protocol endpoint

Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24

Time frame:baseline, Week 24

Postprandial glucose

change from baseline, improvement

Posted result

Group	Least-squares mean · mmol/L	95% CI
Group A (Exenatide)Morning Pre-Meal	-1.87	-
2 Hours Post Morning Meal	-2.67	-
Midday Pre-Meal	-1.40	-
2 Hours Post Midday Meal	-2.12	-
Evening Pre-Meal	-1.57	-
2 Hours Post Evening Meal	-3.09	-
Group B (Placebo)Morning Pre-Meal	-1.20	-
2 Hours Post Morning Meal	-1.92	-
Midday Pre-Meal	-1.37	-
2 Hours Post Midday Meal	-1.51	-
Evening Pre-Meal	-1.32	-
2 Hours Post Evening Meal	-2.28	-

Secondary/protocol endpoint

Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline

Time frame:baseline, Week 24

ratio, improvement

Posted result

Group	Geometric mean · Ratio	95% CI
Group A (Exenatide)	1.46	-
Group B (Placebo)	1.29	-

p0.1827ANCOVA

Secondary/protocol endpoint

Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline

Time frame:baseline, Week 24

HOMA-IR (insulin sensitivity)

ratio, improvement

Posted result

Group	Geometric mean · Ratio	95% CI
Group A (Exenatide)	1.08	-
Group B (Placebo)	0.97	-

p0.1584ANCOVA

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24

Time frame:baseline, Week 24

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Least-squares mean · mmol/L	95% CI
Group A (Exenatide)	0.02	-
Group B (Placebo)	0.02	-

p0.8279ANCOVA

Secondary/protocol endpoint

Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24

Time frame:baseline, Week 24

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Least-squares mean · mmol/L	95% CI
Group A (Exenatide)	-0.06	-
Group B (Placebo)	-0.04	-

p0.8334ANCOVA

Secondary/protocol endpoint

Change From Baseline in Total Cholesterol at Week 24

Time frame:baseline, week 24

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Least-squares mean · mmol/L	95% CI
Group A (Exenatide)	-0.16	-
Group B (Placebo)	-0.03	-

p0.2881ANCOVA

Secondary/protocol endpoint

Ratio of Triglycerides at Week 24 to Triglycerides at Baseline

Time frame:baseline, Week 24

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Geometric mean · Ratio	95% CI
Group A (Exenatide)	0.83	-
Group B (Placebo)	0.92	-

p0.0654ANCOVA

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of Participants With Hypoglycemic Events During the Study

Time frame:Baseline to 24 weeks

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Number · participants	95% CI
Group A (Exenatide)	33	-
Group B (Placebo)	30	-

p0.728Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Rate of Hypoglycemic Events

Time frame:24 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Least-squares mean · events per patient per year	95% CI
Group A (Exenatide)	7.14	-
Group B (Placebo)	4.58	-

p0.127ANOVA

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

Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index.
Postgraduate medicine2012 Jul (month)PMID22913891doi:10.3810/pgm.2012.07.2567via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.