An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes
NCT ID: NCT00229658
Last Updated: 2015-03-25
Study Results
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View full resultsBasic Information
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COMPLETED
1297 participants
OBSERVATIONAL
2005-09-30
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Type 1
Patients with type 1 diabetes
pramlintide acetate
Subcutaneous injection prior to each major meal
Type 2
Patients with type 2 diabetes
pramlintide acetate
Subcutaneous injection prior to each major meal
Interventions
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pramlintide acetate
Subcutaneous injection prior to each major meal
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have A1C \<=9.0% within 3 months of study enrollment
* Are receiving ongoing diabetes care under the guidance of a Health Care Provider (HCP) trained in the use of SYMLIN
Exclusion Criteria
* Are poorly compliant with prescribed blood glucose self monitoring, as defined by their HCP
* Have experienced recurrent patient-ascertained severe hypoglycemia requiring assistance during the past 6 months
* Have hypoglycemia unawareness
* Have a confirmed diagnosis of gastroparesis
* Require the use of drugs that stimulate gastrointestinal motility
* Are female and pregnant or lactating and for whom the HCP determines the potential benefit does not justify the potential risk to the fetus or infant
* Have been treated with SYMLIN within 3 months prior to study start
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Vice President, Medical Development, MD
Role: STUDY_DIRECTOR
Amylin Pharmaceuticals, LLC.
Locations
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Research Site
Birmingham, Alabama, United States
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Montgomery, Alabama, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
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Encinitas, California, United States
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Escondido, California, United States
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Fresno, California, United States
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Lafayette, California, United States
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Moreno Valley, California, United States
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Sacramento, California, United States
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Salinas, California, United States
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Santa Barbara, California, United States
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Torrance, California, United States
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Vacaville, California, United States
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Arvada, Colorado, United States
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Aurora, Colorado, United States
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Norwalk, Connecticut, United States
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Wilmington, Delaware, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Plantation, Florida, United States
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Tallahassee, Florida, United States
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Winter Haven, Florida, United States
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Canton, Georgia, United States
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Columbus, Georgia, United States
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Roswell, Georgia, United States
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Valdosta, Georgia, United States
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‘Aiea, Hawaii, United States
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Caldwell, Idaho, United States
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Idaho Falls, Idaho, United States
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Pocatello, Idaho, United States
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Evergreen Park, Illinois, United States
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Wheaton, Illinois, United States
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Fort Wayne, Indiana, United States
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Franklin, Indiana, United States
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Indianapolis, Indiana, United States
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Des Moines, Iowa, United States
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Shawnee Mission, Kansas, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Lafayette, Louisiana, United States
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Laplace, Louisiana, United States
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Glen Burnie, Maryland, United States
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Towson, Maryland, United States
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Ann Arbor, Michigan, United States
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Bloomfield, Michigan, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Duluth, Minnesota, United States
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Eagan, Minnesota, United States
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Butte, Montana, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Hamilton, New Jersey, United States
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Jersey City, New Jersey, United States
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Livingston, New Jersey, 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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North Plainfield, New Jersey, United States
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Albany, New York, United States
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Binghamton, New York, United States
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Forest Hills, New York, United States
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Lawrence, New York, United States
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New York, New York, United States
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Riverhead, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
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Utica, New York, United States
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Greensboro, North Carolina, United States
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Morehead City, North Carolina, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Mentor, Ohio, United States
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Toledo, Ohio, United States
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Portland, Oregon, United States
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Salem, Oregon, United States
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Bridgeville, Pennsylvania, United States
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Carlisle, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Sewickley, Pennsylvania, United States
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Columbia, South Carolina, United States
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Orangeburg, 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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Hendersonville, Tennessee, United States
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Hixon, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Provo, Utah, United States
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Salt Lake City, Utah, United States
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McLean, Virginia, United States
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Norton, Virginia, United States
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Puyallup, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Walla Walla, Washington, United States
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Milwaukee, Wisconsin, United States
Countries
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References
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Pencek R, Roddy T, Peters Y, De Young MB, Herrmann K, Meller L, Nguyen H, Chen S, Lutz K. Safety of pramlintide added to mealtime insulin in patients with type 1 or type 2 diabetes: a large observational study. Diabetes Obes Metab. 2010 Jun;12(6):548-51. doi: 10.1111/j.1463-1326.2010.01201.x.
Other Identifiers
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137-161
Identifier Type: -
Identifier Source: org_study_id
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