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This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.Ingredients: D-Mannitol 43.0 mg/mL Metacresol 2.25 mg/mL Glacial acetic acid 1.53 mg/mL Sodium acetate trihydrate 0.61 mg/mL pH 4.0 Water for injection qs to 5.0 mL |
|
| Pramlintide Acetate (AC137) | Active Comparator | Pramlintide acetate (AC137) 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. The strength of pramlintide injection is 0.6 mg/mL |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramlintide acetate | Drug | Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| - To investigate the safety of pramlintide treatment employing dose titration upon initiation of pramlintide followed by insulin dose optimization in subjects with type 1 diabetes. | 29 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| - To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study. | 29 Weeks | |
| - To examine the pattern of daily insulin use over the course of the study. | 29 Weeks |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ana Ventures LLC | Mesa | Arizona | 85204 | United States | ||
| Phoenix Endocrinology Clinic, Ltd. |
| 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. |
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| Placebo | Drug | The placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper. |
|
| Phoenix |
| Arizona |
| 85006 |
| United States |
| East Bay Clinical Trial Center | Concord | California | United States |
| Valley Research | Fresno | California | United States |
| UCSD Diabetes Research Center | San Diego | California | United States |
| Diabetes Research Institute | San Mateo | California | United States |
| Sansum Medical Research Institute | Santa Barbara | California | United States |
| Diablo Clinical Research | Walnut Creek | California | United States |
| Barbara Davis Center for Childhood Diabetes | Denver | Colorado | 80262 | United States |
| MedStar Clinical Research Center | Washington D.C. | District of Columbia | United States |
| Medical Research Unlimited | Aventura | Florida | 33180 | United States |
| Medical Research Unlimited | Aventura | Florida | United States |
| Internal Medicine Associates | Fort Myers | Florida | United States |
| Suncoast Clinical Research | New Port Richey | Florida | United States |
| Children's Clinic | Tallahassee | Florida | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | United States |
| St. James Diabetes Center | Chicago Heights | Illinois | 60411 | United States |
| St. James Diabetes Center | Chicago Heights | Illinois | United States |
| Indiana University Outpatient Clinical Research | Indianapolis | Indiana | United States |
| University of Maryland Joslin Diabetes Center | Baltimore | Maryland | 21012 | United States |
| Henry Ford Health System | Detroit | Michigan | United States |
| Grand Rapids Associated Interns | Grand Rapids | Michigan | United States |
| Radiant Research | St Louis | Missouri | 63141 | United States |
| Mercury Street Medical | Butte | Montana | United States |
| UNC Diabetes Care Center | Durham | North Carolina | 27713 | United States |
| Ohio State Univ.-Division of Endocrinology, Diabetes | Columbus | Ohio | 43210 | United States |
| Radiant Research | Portland | Oregon | United States |
| Physicians for Clinical Research | Camp Hill | Pennsylvania | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | United States |
| North Texas Clinical Research | Irving | Texas | United States |
| Private Practice | Lufkin | Texas | 75904 | United States |
| Private Practice | Lufkin | Texas | United States |
| Rainier Clinical Research Center | Renton | Washington | United States |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| 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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