Exenatide Compared with Twice-Daily Biphasic Insulin Aspart in Patients with Type 2 Diabetes Using Sulfonylurea and Metformin

Exclusion Criteria

• - Patients are investigator site personnel
• directly affiliated with the study, or are
• immediate family of investigator site
• personnel directly affiliated with the study.
• - Patients are employed by Lilly or Amylin.
• - Patients have previously, in this or any other study, received exenatide or glucagon-like peptide-1 analogs.
• - Patients have participated in an
• interventional medical, surgical, or
• pharmaceutical study within 30 days prior to
• screening. This criterion includes drugs
• that have not received regulatory approval
• for any indication at the time of study entry.
• - Patients have had greater than three episodes
• of severe hypoglycemia within 6 months prior
• to screening.
• - Patients have less than 5 years of remission history from any malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer).
• - Patients have cardiac disease that is Class
• III or IV, according to the New York Heart
• Association criteria.
• - Patients have a known allergy or
• hypersensitivity to biphasic insulin aspart, exenatide, or excipients contained in these agents.
• - Patients have characteristics
• contraindicating metformin or sulfonylurea
• use, according to product-specific label.
• - Patients have a history of renal
• transplantation or are currently receiving
• renal dialysis or have serum creatinine >=1.5
• mg/dL for males and >=1.2 mg/dL for females.
• - Patients have obvious clinical signs or
• symptoms of liver disease, acute or chronic
• hepatitis, or alanine aminotransferase/serum
• glutamic pyruvic transaminase greater than
• three times the upper limit of the reference
• range.
• - Patients have known hemoglobinopathy or
• chronic anemia.
• - Patients have active proliferative retinopathy or macular edema.
• - Patients are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility, including but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics.
• - Patients are receiving chronic (lasting
• longer than 2 weeks) systemic glucocorticoid
• therapy (excluding topical and inhaled
• preparations) or have received such therapy
• within 2 weeks immediately prior to screening.
• - Patients have used any prescription drug to
• promote weight loss within 3 months prior to
• screening.
• - Patients have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, thiazolidinediones, alpha-glucosidase inhibitors, meglitinides.
• - Patients have any other condition (including
• known drug or alcohol abuse or psychiatric
• disorder) that precludes them from following
• and completing the protocol, in the opinion
• of the investigator.
• - Patients fail to satisfy the investigator of
• suitability to participate for any other
• reason.