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The purpose of this study is to evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes who are not achieving glycemic targets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pramlintide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pramlintide acetate | Drug | Clear, colorless, sterile solution for SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes. | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effects of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes on markers of cardiovascular risk, fasting serum lipids, fasting plasma glucose, waist circumference, and patient-reported outcomes. | 16 Weeks |
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Inclusion Criteria:
Exclusion 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 | Phoenix | Arizona | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19049375 | Derived | Peyrot M, Rubin RR, Polonsky WH. Diabetes distress and its association with clinical outcomes in patients with type 2 diabetes treated with pramlintide as an adjunct to insulin therapy. Diabetes Technol Ther. 2008 Dec;10(6):461-6. doi: 10.1089/dia.2008.0031. | |
| 18031595 | Derived | Wysham C, Lush C, Zhang B, Maier H, Wilhelm K. Effect of pramlintide as an adjunct to basal insulin on markers of cardiovascular risk in patients with type 2 diabetes. Curr Med Res Opin. 2008 Jan;24(1):79-85. doi: 10.1185/030079908x253537. |
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| Concord |
| California |
| United States |
| Research Site | La Jolla | California | United States |
| Research Site | Los Gatos | California | United States |
| Research Site | Salinas | California | United States |
| Research Site | Walnut Creek | California | United States |
| Research Site | Denver | Colorado | United States |
| Research Site | New Britain | Connecticut | United States |
| Research Site | Washington D.C. | District of Columbia | United States |
| Research Site | Palm Harbor | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Lexington | Kentucky | United States |
| Research Site | Baton Rouge | Louisiana | United States |
| Research Site | Bloomfield Hills | Michigan | United States |
| Research Site | Detroit | Michigan | United States |
| Research Site | Grand Rapids | Michigan | United States |
| Research Site | Chesterfield | Missouri | United States |
| Research Site | Butte | Montana | United States |
| Research Site | Omaha | Nebraska | United States |
| Research Site | Charlotte | North Carolina | United States |
| Research Site | Durham | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Medford | Oregon | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Tipton | Pennsylvania | United States |
| Research Site | Nashville | Tennessee | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Charlottesville | Virginia | United States |
| Research Site | Olympia | Washington | United States |
| Research Site | Spokane | Washington | United States |
| 17698615 | Derived | Riddle M, Frias J, Zhang B, Maier H, Brown C, Lutz K, Kolterman O. Pramlintide improved glycemic control and reduced weight in patients with type 2 diabetes using basal insulin. Diabetes Care. 2007 Nov;30(11):2794-9. doi: 10.2337/dc07-0589. Epub 2007 Aug 13. |
| ID | Term |
|---|---|
| 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 |
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| ID | Term |
|---|---|
| C105254 | pramlintide |
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