Back to resultsClinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus
Primary Purpose
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
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 Type 1 Diabetes Mellitus focused on measuring Diabetes, Amylin, Symlin, pramlintide acetate
Eligibility Criteria
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pramlintide
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
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00108004
Brief Title
Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus
Official Title
A Phase 3B, Multicenter, Open-Label Study Investigating the Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Insulin Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2003 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Keywords
Diabetes, Amylin, Symlin, pramlintide acetate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pramlintide
Arm Type
Experimental
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
Intervention Type
Drug
Intervention Name(s)
pramlintide acetate
Intervention Description
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.
Primary Outcome Measure Information:
Title
To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus
Description
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
Title
Understand management issues in subjects with type 1 and type 2 diabetes mellitus
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Anaheim
State/Province
California
Country
United States
Facility Name
Research Site
City
Escondido
State/Province
California
Country
United States
Facility Name
Research Site
City
La Jolla
State/Province
California
Country
United States
Facility Name
Research Site
City
Los Gatos
State/Province
California
Country
United States
Facility Name
Research Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
Research Site
City
Torrance
State/Province
California
Country
United States
Facility Name
Research Site
City
New Britain
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
Norwalk
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
Norwich
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Research Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Research Site
City
Idaho Falls
State/Province
Idaho
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Vincennes
State/Province
Indiana
Country
United States
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Research Site
City
Topeka
State/Province
Kansas
Country
United States
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Research Site
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Wichita
State/Province
Kansas
Country
United States
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Research Site
City
Lexington
State/Province
Kentucky
Country
United States
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Baltimore
State/Province
Maryland
Country
United States
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City
Bloomfield Hills
State/Province
Michigan
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United States
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Tupelo
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Mississippi
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United States
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Las Vegas
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Nevada
Country
United States
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Research Site
City
Reno
State/Province
Nevada
Country
United States
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Research Site
City
Moorestown
State/Province
New Jersey
Country
United States
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Research Site
City
Neptune
State/Province
New Jersey
Country
United States
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Research Site
City
Roseland
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Williston Park
State/Province
New York
Country
United States
Facility Name
Research Site
City
Yonkers
State/Province
New York
Country
United States
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Research Site
City
Greenville
State/Province
North Carolina
Country
United States
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Research Site
City
Lakewood
State/Province
Ohio
Country
United States
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City
Westlake
State/Province
Ohio
Country
United States
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Research Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Wilkes Barre
State/Province
Pennsylvania
Country
United States
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City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Sumter
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
Country
United States
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Research Site
City
Arlington
State/Province
Texas
Country
United States
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City
Dallas
State/Province
Texas
Country
United States
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City
Olympia
State/Province
Washington
Country
United States
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Madison
State/Province
Wisconsin
Country
United States
Facility Name
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Milwaukee
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23748514
Citation
Herrmann K, Frias JP, Edelman SV, Lutz K, Shan K, Chen S, Maggs D, Kolterman OG. Pramlintide improved measures of glycemic control and body weight in patients with type 1 diabetes mellitus undergoing continuous subcutaneous insulin infusion therapy. Postgrad Med. 2013 May;125(3):136-44. doi: 10.3810/pgm.2013.05.2635.
Results Reference
derived
PubMed Identifier
17425446
Citation
Karl D, Philis-Tsimikas A, Darsow T, Lorenzi G, Kellmeyer T, Lutz K, Wang Y, Frias JP. Pramlintide as an adjunct to insulin in patients with type 2 diabetes in a clinical practice setting reduced A1C, postprandial glucose excursions, and weight. Diabetes Technol Ther. 2007 Apr;9(2):191-9. doi: 10.1089/dia.2006.0013.
Results Reference
derived
PubMed Identifier
17109671
Citation
Edelman SV, Darsow T, Frias JP. Pramlintide in the treatment of diabetes. Int J Clin Pract. 2006 Dec;60(12):1647-53. doi: 10.1111/j.1742-1241.2006.01187.x.
Results Reference
derived
Learn more about this trial
Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus
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