Effect of Different Fixed Pramlintide:Insulin Dose Ratios on Postprandial Glucose in T1DM

Exclusion Criteria

• •Has experienced recurrent severe hypoglycemia requiring assistance within 6 months before Visit 1 Screening
• •Has a history of hypoglycemia unawareness
• •Has a confirmed diagnosis of gastroparesis
• •Has been treated, is currently being treated, or is expected to require or undergo treatment with the following medications:
• •1. Any antihyperglycemic agent other than insulin
• •2. Drugs that directly affect gastrointestinal motility (e.g., anticholinergic agents such as atropine)
• •3. Drugs that slow the intestinal absorption of nutrients (e.g., α-glucosidase inhibitors.
• •Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:
• •1. Hepatic disease
• •2. Renal disease
• •3. Gastrointestinal disease
• •4. Pulmonary disease
• •5. Organ transplantation
• •6. Chronic infection (e.g., tuberculosis, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus)
• •Is currently treated or has been previously treated with SYMLIN/pramlintide or has participated in a SYMLIN/pramlintide clinical study within 3 months of Visit 1 (Screening).
• •Has any clinically significant laboratory findings or medical history that may affect successful completion of the study and/or personal well-being
• •Has donated blood within 2 months or is planning to donate blood during the study.
• •Has had a major surgery or a blood transfusion within 2 months
• •Has received any investigational drug within 1 month
• •Has known allergies or hypersensitivity to any component of study treatment.
• •Is an immediate family member of personnel directly affiliated with the study at the clinical study site, or is directly affiliated with the study at the clinical study site.
• •Is employed by Amylin Pharmaceuticals, Inc (Amylin) (that is an employee, temporary contract worker, or designee responsible for the conduct of the study).