Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus
A Multicenter, Open-Label, Extension Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus Completing Protocol 137-150
1 other identifier
interventional
190
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2002
Typical duration for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
April 5, 2005
CompletedFirst Posted
Study publicly available on registry
April 6, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedSeptember 23, 2015
August 1, 2015
2.6 years
April 5, 2005
September 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To investigate the long term safety profile of pramlintide treatment in subjects with type 1 diabetes completing protocol 137-150.
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
participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available
Secondary Outcomes (1)
To examine the effects of long term pramlintide treatment on HbA1c in subjects with type 1 diabetes completing protocol 137-150.
participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available
Study Arms (1)
Pramlintide Acetate
ACTIVE COMPARATORPramlintide acetate injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The concentration of pramlintide injection to be used in this study is 0.6 mg/mL.
Interventions
Eligibility Criteria
You may qualify if:
- The subject has completed the full dosing period in Protocol 137-150.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (25)
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
Research Site
Renton, Washington, United States
Related Publications (1)
Kovatchev BP, Crean J, McCall A. Pramlintide reduces the risks associated with glucose variability in type 1 diabetes. Diabetes Technol Ther. 2008 Oct;10(5):391-6. doi: 10.1089/dia.2007.0295.
PMID: 18715216DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lisa Porter, MD
Amylin Pharmaceuticals, LLC.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2005
First Posted
April 6, 2005
Study Start
November 1, 2002
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
September 23, 2015
Record last verified: 2015-08