An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
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.
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 -  Have previously completed or withdrawn from this study.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.