This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Pramlintide (0.6 mg/mL) in 5.0-mL multiple-draw glass vials for SC injection for 12weekes and after Pramlintide (1.0 mg/mL) 1.5 mL pen-cartridge. Subjects who do not switch to the pen-cartridge device at Week 12 will continue to administer pramlintide using a syringe and vial.
To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus
To investigate the clinical utility (change in HbA1c, seven-point glucose profile, body weight, and insulin use) and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy.
Time frame: 6 months
Understand management issues in subjects with type 1 and type 2 diabetes mellitus
To collect data regarding the selection of subjects for pramlintide administration by healthcare professionals and to further understand management issues in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy
Time frame: 6 months
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Research Site
Anaheim, California, United States
Research Site
Escondido, California, United States
Research Site
La Jolla, California, United States
Research Site
Los Gatos, California, United States
Research Site
San Francisco, California, United States
Research Site
Torrance, California, United States
Research Site
New Britain, Connecticut, United States
Research Site
Norwalk, Connecticut, United States
Research Site
Norwich, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
...and 38 more locations