CompletedPhase 3Results posted

An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c ≤10.5%

Primary endpoints

•Immunogenicity (ADA)•Treatment-emergent AEs (any)

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 IDNCT00516048

Org study IDH8O-MC-GWBO

Timeline

Milestones

Study first posted2007-08-14estimated

Results first posted2009-06-17estimated

Last update posted2015-04-07estimated

Study start2007-08 (month precision)

Primary completion2008-04actual (month precision)

Study completion2008-04actual (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with type 2 diabetes.

•Have been exposed to exenatide for at least 3 months in previous Amylin/Lilly Studies H8O-MC-GWAO, H8O-MC-GWAP, H8O-MC-GWAT, or H8O-MC-GWBA.

•Have interrupted exenatide treatment for a period of at least 2 months.

•HbA1c of ≤10.5%.

Exclusion criteria

•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.

•Have previously completed or withdrawn from this study.

•Have taken marketed exenatide (Byetta) during the interim period between studies GWAO, GWAP, GWAT, or GWBA and the current study.

•Used drugs for weight loss (for example, Xenical® [orlistat], Meridia® [sibutramine], Acutrim® [phenylpropanolamine], Accomplia® [rimonabant], or similar over-the-counter medications) within 3 months of screening.

•Are currently treated with any of the following excluded medications: Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.

•Use insulin with daily dosage exceeding 1 U/kg.

Endpoints (3)

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

Safety / tolerability / PK

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint

Time frame:24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Mean · percent	95% CI
Exenatide:Treatment-Emergent Antibody NegativeBaseline HbA1c (Week 0)	8.13	-
Change in HbA1c at endpoint (Week 24)	-1.03	-
Exenatide: Treatment-Emergent Antibody PositiveBaseline HbA1c (Week 0)	8.05	-
Change in HbA1c at endpoint (Week 24)	-0.30	-
Enrolled But Withdrew Before Receiving TreatmentBaseline HbA1c (Week 0)	0	-
Change in HbA1c at endpoint (Week 24)	0	-

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Treatment-emergent Antibody Status (Maximum Titer Level Experienced)

Time frame:24 weeks

Immunogenicity (ADA)

descriptive

Posted result

Group	Number · Participants	95% CI
Exenatide:Treatment-Emergent Antibody NegativeAntibody negative	15	-
Low titer antibodies	0	-
Higher titer antibodies	0	-
Exenatide: Treatment-Emergent Antibody PositiveAntibody negative	0	-
Low titer antibodies	25	-
Higher titer antibodies	17	-
Enrolled But Withdrew Before Receiving TreatmentAntibody negative	0	-
Low titer antibodies	0	-
Higher titer antibodies	0	-

Primary/protocol endpoint

Incidence of Potentially Immune-related Treatment-emergent Adverse Events

Time frame:24 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Number · participants	95% CI
Exenatide:Treatment-Emergent Antibody NegativeArthralgia	1	-
Spinal osteoarthritis	1	-
Injection site pruritis	0	-
Injection site rash	0	-
Rash	0	-
Eye allergy	0	-
Exenatide: Treatment-Emergent Antibody PositiveArthralgia	0	-
Spinal osteoarthritis	0	-
Injection site pruritis	2	-
Injection site rash	1	-
Rash	1	-
Eye allergy	1	-
Enrolled But Withdrew Before Receiving TreatmentArthralgia	0	-
Spinal osteoarthritis	0	-
Injection site pruritis	0	-
Injection site rash	0	-
Rash	0	-
Eye allergy	0	-

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.