Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus
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
1 other identifier
interventional
400
1 country
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2003
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 12, 2005
CompletedFirst Posted
Study publicly available on registry
April 13, 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
CompletedMay 21, 2015
May 1, 2015
2.2 years
April 12, 2005
May 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
6 months
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
6 months
Study Arms (1)
Pramlintide
EXPERIMENTALPramlintide 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (48)
Research Site
Anaheim, California, United States
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Escondido, California, United States
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La Jolla, California, United States
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Los Gatos, California, United States
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San Francisco, California, United States
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Torrance, California, United States
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New Britain, Connecticut, United States
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Norwalk, Connecticut, United States
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Norwich, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Clearwater, Florida, United States
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Orlando, Florida, United States
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Columbus, Georgia, United States
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Honolulu, Hawaii, United States
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Idaho Falls, Idaho, United States
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Indianapolis, Indiana, United States
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Vincennes, Indiana, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Baltimore, Maryland, United States
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Bloomfield Hills, Michigan, United States
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Tupelo, Mississippi, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Moorestown, New Jersey, United States
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Neptune City, New Jersey, United States
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Roseland, New Jersey, United States
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New York, New York, United States
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Williston Park, New York, United States
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Yonkers, New York, United States
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Greenville, North Carolina, United States
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Lakewood, Ohio, United States
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Westlake, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Wilkes-Barre, Pennsylvania, United States
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Charleston, South Carolina, United States
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Sumter, South Carolina, United States
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Chattanooga, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Arlington, Texas, United States
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Dallas, Texas, United States
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Olympia, Washington, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
Related Publications (3)
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.
PMID: 23748514DERIVEDKarl 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.
PMID: 17425446DERIVEDEdelman 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.
PMID: 17109671DERIVED
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2005
First Posted
April 13, 2005
Study Start
April 1, 2003
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
May 21, 2015
Record last verified: 2015-05