Safety of Exenatide Once Weekly in Patients with Type 2 Diabetes Mellitus Treated with Thiazolidinedione Alone or Thiazolidinedione in Combination with Metformin

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, coronary artery bypass surgery, angioplasty.
• - Is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
• - Have obvious clinical signs or symptoms of liver disease, acute or
• chronic hepatitis
• - Have a history of renal transplantation or are currently receiving renal
• dialysis or have serum creatinine ≥135 μmol/L for males and ≥110 μmol/L for females.
• - 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 known hemoglobinopathy or chronic anemia (hemoglobin concentration <11.5 g/dL [115 g/L] for males, <10.5 g/dL [105 g/L] for females).
• - Have clinically significant history or presence of severe gastrointestinal
• disease, particularly those which may impact gastric emptying, such as gastroparesis, pyloric stenosis, or gastric bypass surgery.
• - Have a history of pancreatitis.
• - Have had greater than three episodes of major hypoglycemia within
• 6 months prior to screening.
• - Have any contraindication for the OAD(s) which they use, according to
• local label requirements.
• - Are known to have active proliferative retinopathy.
• - Are receiving chronic (>2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received systemic glucocorticoid therapy for >2 weeks within the 4 weeks immediately preceding screening.
• - 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 previously been treated with glucagon-like peptide 1 analogs or
• liraglutide.
• - Have been treated for longer than 2 weeks with any of the following
• excluded medications within 3 months prior to screening: Insulin; Sulfonylureas; Alpha-glucosidase inhibitors (e.g., Glyset® [miglitol] or Precose® [acarbose]); Meglitinides (e.g., Prandin® [repaglinide] or Starlix® [nateglinide]); 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 participating in an interventional medical, surgical, or
• pharmaceutical study (a study in which an experimental, drug, medical,
• or surgical treatment is given). Patients completing the final visit of a study examining safety/efficacy of exenatide BID may enter this study on the same day if they meet other eligibility criteria.