A Pilot Study of Continuous Subcutaneous Pramlintide Infusion Therapy in Patients With Type 1 Diabetes

Inclusion Criteria: 1. Type 1 diabetes of at least one year duration; 2. Treated with CSII therapy for at least 6 months; 3. Age 18 to 70 years, inclusive; 4. A1C \>7.0 and ≤10% as screening; 5. BMI ≤35 kg/m2; 6. Stable insulin dose (±10%) for at least 3 months prior to screening; 7. If female, has a negative urine pregnancy test at screening; 8. If female and of childbearing potential, practicing and willing to continue to using appropriate contraception to ensure that pregnancy does not occur during the study; 9. Able to understand and sign the required study documents and comply with the protocol requirements Exclusion Criteria: 1. Is poorly compliant with the currently prescribed insulin regimen, as determined by the investigator; 2. Has any significant medical condition, laboratory findings, or medical history that may affect successful completion of the study and/or personal well-being; 3. If female and if of childbearing potential, is pregnant, lactating, or planning to become pregnant; 4. Has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months; 5. Has a history of hypoglycemia unawareness; 6. Has a confirmed diagnosis of gastroparesis; 7. Requires the use of drugs that stimulate gastrointestinal motility; 8. Is receiving medications known to interfere with glycemic control (i.e. glucocorticoids); 9. Has been treated with any oral antidiabetic agent or exenatide within 3 months of screening visit; 10. Has been treated with pramlintide within 3 months of screening visit; 11. Has received an investigational drug within 3 month of screening visit; 12. Is currently participating in a clinical trial