Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients with Type 2 Diabetes Treated with Metformin Alone or in Combination with Sulfonylurea (DURATION - 3)

Exclusion Criteria

• - Have had a clinically significant history of cardiac disease or presence of
• active cardiac disease within the year prior to inclusion in the study,
• including myocardial infarction, clinically significant arrhythmia,
• unstable angina, moderate to severe congestive heart failure, coronary artery
• bypass surgery, or angioplasty; or is expected to require coronary artery
• bypass surgery or angioplasty during the course of the study.
• -Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.
• -Have a history of renal transplantation or are currently receiving renal
• dialysis.
• -Have active or untreated malignancy, or have been in remission from
• clinically significant malignancy (other than basal cell or squamous cell
• skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer)
• for less than 5 years.
• - Have had greater than three episodes of major hypoglycemia within
• 6 months prior to screening.
• - Have any contraindication for the oral antidiabetic agent which they use.
• - Have a known allergy or hypersensitivity to insulin glargine, exenatide
• once weekly, or excipients contained in these agents.
• - Are known to have active proliferative retinopathy.
• - Have been treated with drugs that promote weight loss (e.g., Xenical®
• [orlistat], Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim®
• [phenylpropanolamine], or similar over-the-counter medications) within
• 3 months of screening.
• - Have been treated for longer than 2 weeks with any of the following
• excluded medications within 3 months prior to screening:
• * Insulin
• * Thiazolidinediones (e.g., Actos® [pioglitazone] or Avandia® [rosiglitazone])
• * Alpha-glucosidase inhibitors (e.g., Glyset® [miglitol] or Precose®
• [acarbose])
• * Meglitinides (e.g., Prandin® [repaglinide] or Starlix® [nateglinide]).
• * Byetta® (exenatide BID formulation)
• * Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ [sitagliptin],
• Galvus® [vildagliptin])
• * Symlin® (pramlintide acetate).
• - Have had an organ transplant.
• - Have donated blood within 30 days of screening.
• - Have previously completed or withdrawn from this study or any other
• study investigating exenatide once weekly.
• - 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.
• - Are currently enrolled in any other clinical study.