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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: exenatide


Participation Criteria
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Eligibility Criteria
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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 Have previously completed or withdrawn from this study.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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exenatide:Treatment-Emergent Antibody Negative<br>This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. | Drug: exenatide<br>* subcutaneous injection, 5mcg or 10mcg, twice a day<br>* Other names: LY2148568;|
| Experimental: Exenatide:Treatment-Emergent Antibody Positive<br>This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. | Drug: exenatide<br>* subcutaneous injection, 5mcg or 10mcg, twice a day<br>* Other names: LY2148568;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent Antibody Status (Maximum Titer Level Experienced) | Patients who experienced specified treatment-emergent antibody status at any point during the study (grouped by maximum titer level experienced) | 24 weeks | 
| Incidence of Potentially Immune-related Treatment-emergent Adverse Events | Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint | Change in HbA1c from baseline (Week 0) to endpoint (Week 24) by treatment-emergent antibody status | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exenatide, Byetta, antibodies, Amylin, Lilly