Phase 3
Completed N=58
An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00516048 ↗Enrolled (actual)
58
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Treatment-emergent Antibody Status (Maximum Titer Level Experienced) — 15; 0; 0; 0 Participants
Summary
The primary purpose of this study is to assess the anti-exenatide-antibody response to exenatide re-exposure as measured by anti-exenatide antibodies and incidence of treatment-emergent allergy and hypersensitivity reactions following a period of treatment interruption, in patients previously exposed to exenatide.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-emergent Antibody Status (Maximum Titer Level Experienced) |
15; 0; 0; 0; 25; 0 | — |
| PRIMARY Incidence of Potentially Immune-related Treatment-emergent Adverse Events |
1; 0; 0; 1; 0; 0 | — |
| SECONDARY Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint |
8.13; 8.05; 0; -1.03; -0.30; 0 | — |
Eligibility Criteria
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- Have previously completed or withdrawn from this study.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.
Data sourced from ClinicalTrials.gov (NCT00516048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.