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

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).