effect of different fixed pramlintide:insulin dose ratios on postprandial glucose in t1dm

Conditions: Type 1 Diabetes

Summary: to examine the effects of different fixed pramlintide:insulin dose ratios in subjects with type 1 diabetes on postprandial plasma glucose concentrations


Eligibility criteria:
inclusion criteria: * is 18 to 70 years old * is male, or is female and meets all the following criteria: 1. not breastfeeding 2. negative pregnancy test result and, if of childbearing potential, must practice and be willing to continue to practice appropriate birth control * has been diagnosed with type 1 diabetes mellitus for at least 1 year and not achieving glycemic goal while on mdi of insulin * has hba1c between 7.0% and 9.0% * has been on mdi of regular insulin, at a dose not to exceed 10 units/breakfast for at least 3 months or has been on continuous subcutaneous insulin infusion (csii), at a dose not to exceed 10 units/breakfast, for at least 3 months and is willing to switch to an mdi insulin regimen for 1 day prior to enrollment and through the study * has a body mass index (bmi) \<30 kg/m2 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).

Keywords: pramlintide, insulin, type 1 diabetes, reduction in postprandial glucose, pramlintide:insulin dose-ratio