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

A Phase 1, Randomized, Placebo-Controlled Single-Blind, Dose-Ranging, 4-Way Crossover Study to Evaluate the Effect of Different Fixed Pramlintide: Insulin Dose Ratios on Postprandial Glycemic Control in Subjects With Type 1 Diabetes Mellitus

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

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).