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An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
Lead sponsor
Asset
Exenatide
Subcutaneous · GLP-1 agonist
Listed sites
13
Recruiting sites
—
Enrollment
58
actual
Study population
Type 2 diabetes
Key I/E criterion
•HbA1c ≤10.5%
Primary endpoints
•Immunogenicity (ADA)•Treatment-emergent AEs (any)
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
Exclusion criteria
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
Glycemic / diabetes
1 endpointChange in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
Time frame:24 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (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 endpointsTreatment-emergent Antibody Status (Maximum Titer Level Experienced)
Time frame:24 weeks
Immunogenicity (ADA)
descriptive
Posted result
| Group | Value (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 | — |
Incidence of Potentially Immune-related Treatment-emergent Adverse Events
Time frame:24 weeks
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (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 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.