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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pramlintide | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pramlintide acetate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Porter, MD | Amylin Pharmaceuticals, LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anaheim | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23748514 | Derived | 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. | |
| 17425446 | Derived |
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|
| Escondido |
| California |
| United States |
| Research Site | La Jolla | California | United States |
| Research Site | Los Gatos | California | United States |
| Research Site | San Francisco | California | United States |
| Research Site | Torrance | California | United States |
| Research Site | New Britain | Connecticut | United States |
| Research Site | Norwalk | Connecticut | United States |
| Research Site | Norwich | Connecticut | United States |
| Research Site | Washington D.C. | District of Columbia | United States |
| Research Site | Clearwater | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Columbus | Georgia | United States |
| Research Site | Honolulu | Hawaii | United States |
| Research Site | Idaho Falls | Idaho | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Vincennes | Indiana | United States |
| Research Site | Topeka | Kansas | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Lexington | Kentucky | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Bloomfield Hills | Michigan | United States |
| Research Site | Tupelo | Mississippi | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Reno | Nevada | United States |
| Research Site | Moorestown | New Jersey | United States |
| Research Site | Neptune City | New Jersey | United States |
| Research Site | Roseland | New Jersey | United States |
| Research Site | New York | New York | United States |
| Research Site | Williston Park | New York | United States |
| Research Site | Yonkers | New York | United States |
| Research Site | Greenville | North Carolina | United States |
| Research Site | Lakewood | Ohio | United States |
| Research Site | Westlake | Ohio | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Wilkes-Barre | Pennsylvania | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Sumter | South Carolina | United States |
| Research Site | Chattanooga | Tennessee | United States |
| Research Site | Knoxville | Tennessee | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Nashville | Tennessee | United States |
| Research Site | Arlington | Texas | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Olympia | Washington | United States |
| Research Site | Madison | Wisconsin | United States |
| Research Site | Milwaukee | Wisconsin | United States |
| 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. |
| 17109671 | Derived | 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. |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C105254 | pramlintide |
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