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This trial is conducted in the United States of America (USA). It is demonstrated that intensive insulin therapy resulting in good glycaemic control can reduce or delay the incidence of complications secondary to Type 1 Diabetes. Insulin Aspart (NovoLog®) is an ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin injection (CSII) therapy in the pediatric and adolescent age population. This trial compares the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered by CSII in children and adolescents with type 1 diabetes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin lispro | Drug | |||
| insulin aspart | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | After 16 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Measurements of glycaemic control, safety parameters including frequency of hypoglycaemia, laboratory tests, clinical evaluations and adverse events |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Mobile | Alabama | 36617 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17989308 | Result | Weinzimer SA, Ternand C, Howard C, Chang CT, Becker DJ, Laffel LM; Insulin Aspart Pediatric Pump Study Group. A randomized trial comparing continuous subcutaneous insulin infusion of insulin aspart versus insulin lispro in children and adolescents with type 1 diabetes. Diabetes Care. 2008 Feb;31(2):210-5. doi: 10.2337/dc07-1378. Epub 2007 Nov 5. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Montgomery |
| Alabama |
| 36106 |
| United States |
| Novo Nordisk Investigational Site | Phoenix | Arizona | 85016 | United States |
| Novo Nordisk Investigational Site | Little Rock | Arkansas | 72202 | United States |
| Novo Nordisk Investigational Site | Loma Linda | California | 92354 | United States |
| Novo Nordisk Investigational Site | Sacramento | California | 95816 | United States |
| Novo Nordisk Investigational Site | San Diego | California | 92123 | United States |
| Novo Nordisk Investigational Site | Denver | Colorado | 80262 | United States |
| Novo Nordisk Investigational Site | Englewood | Colorado | 80110 | United States |
| Novo Nordisk Investigational Site | New Haven | Connecticut | 06520 | United States |
| Novo Nordisk Investigational Site | Orlando | Florida | 32806-1101 | United States |
| Novo Nordisk Investigational Site | St. Petersburg | Florida | 33701 | United States |
| Novo Nordisk Investigational Site | Tallahassee | Florida | 32308 | United States |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30318 | United States |
| Novo Nordisk Investigational Site | Idaho Falls | Idaho | 83404-7596 | United States |
| Novo Nordisk Investigational Site | Indianapolis | Indiana | 46202-2879 | United States |
| Novo Nordisk Investigational Site | Iowa City | Iowa | 52242 | United States |
| Novo Nordisk Investigational Site | Topeka | Kansas | 66606 | United States |
| Novo Nordisk Investigational Site | Wichita | Kansas | 67226 | United States |
| Novo Nordisk Investigational Site | Baton Rouge | Louisiana | 70808 | United States |
| Novo Nordisk Investigational Site | Baltimore | Maryland | 21229 | United States |
| Novo Nordisk Investigational Site | Baltimore | Maryland | 21287 | United States |
| Novo Nordisk Investigational Site | Boston | Massachusetts | 02115 | United States |
| Novo Nordisk Investigational Site | Boston | Massachusetts | 02215 | United States |
| Novo Nordisk Investigational Site | Springfield | Massachusetts | 01107 | United States |
| Novo Nordisk Investigational Site | Worcester | Massachusetts | 01655 | United States |
| Novo Nordisk Investigational Site | Detroit | Michigan | 48202-2689 | United States |
| Novo Nordisk Investigational Site | Minneapolis | Minnesota | 55416 | United States |
| Novo Nordisk Investigational Site | Minneapolis | Minnesota | 55455 | United States |
| Novo Nordisk Investigational Site | Kansas City | Missouri | 64108 | United States |
| Novo Nordisk Investigational Site | Omaha | Nebraska | 68114 | United States |
| Novo Nordisk Investigational Site | Omaha | Nebraska | 68198-3020 | United States |
| Novo Nordisk Investigational Site | Hackensack | New Jersey | 07601 | United States |
| Novo Nordisk Investigational Site | Brooklyn | New York | 11219 | United States |
| Novo Nordisk Investigational Site | Buffalo | New York | 14222 | United States |
| Novo Nordisk Investigational Site | Manhasset | New York | 11030 | United States |
| Novo Nordisk Investigational Site | The Bronx | New York | 10467 | United States |
| Novo Nordisk Investigational Site | Asheville | North Carolina | 28803 | United States |
| Novo Nordisk Investigational Site | Chapel Hill | North Carolina | 27599-7220 | United States |
| Novo Nordisk Investigational Site | Columbus | Ohio | 43203 | United States |
| Novo Nordisk Investigational Site | Tulsa | Oklahoma | 74136 | United States |
| Novo Nordisk Investigational Site | Portland | Oregon | 97239 | United States |
| Novo Nordisk Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | 15224 | United States |
| Novo Nordisk Investigational Site | Charleston | South Carolina | 29425 | United States |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78229 | United States |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78284 | United States |
| Novo Nordisk Investigational Site | Norfolk | Virginia | 23507 | United States |
| Novo Nordisk Investigational Site | Seattle | Washington | 98105 | United States |
| Novo Nordisk Investigational Site | Charleston | West Virginia | 25302 | United States |
| Novo Nordisk Investigational Site | Milwaukee | Wisconsin | 53226-0509 | United States |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| 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 |
|---|---|
| D061268 | Insulin Lispro |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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