A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension

Exclusion Criteria

• •Clinically significant medical condition that could potentially affect study participation including:
• •Acute or chronic pancreatitis
• •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type 2
• •Active cardiovascular disease within 3 months of study start
• •Underlying hepatic or renal disease
• •Inflammatory bowel disease, or other severe gastrointestinal diseases (particularly those that may affect gastric emptying, such as gastroparesis, pyloric stenosis, and metabolic surgery)
• •Has had \> 2 episodes of major hypoglycemia in the preceding 6 months before study start
• •Has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start
• •Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:
• •* Any exposure to exenatide (BYETTA®, exenatide once weekly, or exenatide suspension), liraglutide (Victoza®), or any GLP-1 receptor agonist
• •* Any DPP-IV inhibitor, sulfonylurea (SU), or rosiglitazone (Avandia®) within 3 months prior to study start
• •* Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days prior to study start
• •* Insulin within 2 weeks prior to study start, or for more than 1 week within 3 months prior to study start
• •* Systemic corticosteroids by oral, intravenous, intra-articular, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
• •* Prescription or over-the-counter weight loss medications within 3 months prior to study start