Clinical trial NCT01708044 (phase 1, status: completed)
Conditions: type 1 diabetes
ICD codes: E10.65, E10.9, E10.21, E10.36, E10.41, E10.42, E10.44
Drugs: pramlintide acetate
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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).