Back to resultsStudy of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
pramlintide acetate
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes, Amylin, pramlintide, Symlin
Eligibility Criteria
Inclusion Criteria: The subject has completed the full dosing period in Protocol 137-150.
Sites / Locations
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Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Pramlintide Acetate
Arm Description
Pramlintide 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.
Outcomes
Primary Outcome Measures
To investigate the long term safety profile of pramlintide treatment in subjects with type 1 diabetes completing protocol 137-150.
To examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight
Secondary Outcome Measures
To examine the effects of long term pramlintide treatment on HbA1c in subjects with type 1 diabetes completing protocol 137-150.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00107107
Brief Title
Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus
Official Title
A Multicenter, Open-Label, Extension Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus Completing Protocol 137-150
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Diabetes, Amylin, pramlintide, Symlin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pramlintide Acetate
Arm Type
Active Comparator
Arm Description
Pramlintide 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.
Intervention Type
Drug
Intervention Name(s)
pramlintide acetate
Intervention Description
Syringe vial and Pen-cartridge
Primary Outcome Measure Information:
Title
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
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject has completed the full dosing period in Protocol 137-150.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Porter, MD
Organizational Affiliation
Amylin Pharmaceuticals, LLC.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Tempe
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Concord
State/Province
California
Country
United States
Facility Name
Research Site
City
Fresno
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
San Mateo
State/Province
California
Country
United States
Facility Name
Research Site
City
Santa Barbara
State/Province
California
Country
United States
Facility Name
Research Site
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Research Site
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
Research Site
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Tallahassee
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Grand Rapids
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
St. Peters
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Butte
State/Province
Montana
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Camp Hill
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Irving
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Renton
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18715216
Citation
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.
Results Reference
derived
Learn more about this trial
Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus
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