DRUG
pramlintide acetate
Syringe vial and Pen-cartridge
Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Enrollment
190
Locations
25
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
This is a multicenter, open-label extension study designed to examine the long-term safety of pramlintide treatment in subjects with type 1 diabetes who have successfully completed treatment in the parent study 137-150.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Apr 6, 2005
Study start
Nov 2002
Primary completion
Jun 2005
Study completion
Jun 2005
Results posted
Not reported
Registry updated
Sep 23, 2015
Outcomes
What the study measures.
Primary outcomes
To investigate the long term safety profile of pramlintide treatment in subjects with type 1 diabetes completing protocol 137-150.
Time frame · participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available
To examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight
Time frame · participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available
Secondary outcomes
To examine the effects of long term pramlintide treatment on HbA1c in subjects with type 1 diabetes completing protocol 137-150.
Time frame · participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * The subject has completed the full dosing period in Protocol 137-150.
Study locations
25 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Research Site
Tempe, Arizona, United States
Research Site
Concord, California, United States
Research Site
Fresno, California, United States
Research Site
San Diego, California, United States
Research Site
San Mateo, California, United States
Research Site
Santa Barbara, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Aventura, Florida, United States
Research Site
Fort Myers, Florida, United States
Research Site
New Port Richey, Florida, United States
Research Site
Tallahassee, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Detroit, Michigan, United States
Research Site
Grand Rapids, Michigan, United States
Research Site
City of Saint Peters, Missouri, United States
Research Site
Butte, Montana, United States
Research Site
Durham, North Carolina, United States
Research Site
Columbus, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Camp Hill, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
Research Site
Irving, Texas, United States
Research Site
San Antonio, Texas, United States
Publications
Results and literature.
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More studies on Pramlintide.
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Related PeptideStat pages
Put the record in context.
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