Status
Completed
Phase
Phase 3
Enrollment
400
Locations
48
Results
Not posted
Publications
3
Study summary
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.
Interventions
DRUG
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.
Timeline
First posted
Apr 13, 2005
Study start
Apr 2003
Primary completion
Jun 2005
Study completion
Jun 2005
Results posted
Not reported
Registry updated
May 21, 2015
Outcomes
To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus
Time frame · 6 months
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.
Understand management issues in subjects with type 1 and type 2 diabetes mellitus
Time frame · 6 months
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
Not reported in the indexed record.
Eligibility
Inclusion Criteria: * The subject has a clinical diagnosis of type 1 diabetes mellitus requiring treatment with insulin for a minimum of 6 months at Screening; -OR- The subject has a clinical diagnosis of type 2 diabetes requiring treatment with insulin with or without oral antidiabetic agents for a minimum of 6 months at Screening. * The subject has a HbA1c of 7.0% to 11.0% at Screening.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
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
Research Site
Clearwater, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Columbus, Georgia, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Idaho Falls, Idaho, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Vincennes, Indiana, United States
Research Site
Topeka, Kansas, United States
Research Site
Wichita, Kansas, United States
Research Site
Lexington, Kentucky, United States
Research Site
Baltimore, Maryland, United States
Research Site
Bloomfield Hills, Michigan, United States
Research Site
Tupelo, Mississippi, United States
Research Site
Las Vegas, Nevada, United States
Publications
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