Diabetes Clinical Trial
Official title:
Basal/Bolus Therapy With Insulin Aspart (NovoLog®) Versus Regular Human Insulin (Novolin® R) or Insulin Lispro (Humalog®) in Combination With NPH: An Open-Label, Randomized, Parallel Group, Multicenter Study in Children and Adolescents With Type 1 Diabetes
| Verified date | December 2016 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This trial is conducted in the United States of America (USA). The aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients.
| Status | Completed |
| Enrollment | 378 |
| Est. completion date | June 2004 |
| Est. primary completion date | June 2004 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 6 Years to 18 Years |
| Eligibility |
Inclusion Criteria: - Pediatric patients with Type 1 diabetes for at least one year - HbA1c less than 12% - Willing to administer at least 3 injections per day - Willing to perform self monitored blood glucose (SMBG) at least 4 times per day, includes subject and/or parent/guardian, as necessary |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Novo Nordisk Investigational Site | Akron | Ohio |
| United States | Novo Nordisk Investigational Site | Albany | New York |
| United States | Novo Nordisk Investigational Site | Albuquerque | New Mexico |
| United States | Novo Nordisk Investigational Site | Ann Arbor | Michigan |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Baltimore | Maryland |
| United States | Novo Nordisk Investigational Site | Baltimore | Maryland |
| United States | Novo Nordisk Investigational Site | Baton Rouge | Louisiana |
| United States | Novo Nordisk Investigational Site | Birmingham | Alabama |
| United States | Novo Nordisk Investigational Site | Boston | Massachusetts |
| United States | Novo Nordisk Investigational Site | Boston | Massachusetts |
| United States | Novo Nordisk Investigational Site | Brooklyn | New York |
| United States | Novo Nordisk Investigational Site | Buffalo | New York |
| United States | Novo Nordisk Investigational Site | Chapel Hill | North Carolina |
| United States | Novo Nordisk Investigational Site | Charleston | South Carolina |
| United States | Novo Nordisk Investigational Site | Cleveland | Ohio |
| United States | Novo Nordisk Investigational Site | Columbia | South Carolina |
| United States | Novo Nordisk Investigational Site | Columbus | Ohio |
| United States | Novo Nordisk Investigational Site | Corpus Christi | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Danville | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Dayton | Ohio |
| United States | Novo Nordisk Investigational Site | Englewood | Colorado |
| United States | Novo Nordisk Investigational Site | Erie | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Gainesville | Florida |
| United States | Novo Nordisk Investigational Site | Gainesville | Florida |
| United States | Novo Nordisk Investigational Site | Greer | South Carolina |
| United States | Novo Nordisk Investigational Site | Hackensack | New Jersey |
| United States | Novo Nordisk Investigational Site | Hartford | Connecticut |
| United States | Novo Nordisk Investigational Site | Hershey | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Idaho Falls | Idaho |
| United States | Novo Nordisk Investigational Site | Indianapolis | Indiana |
| United States | Novo Nordisk Investigational Site | Indianapolis | Indiana |
| United States | Novo Nordisk Investigational Site | Iowa City | Iowa |
| United States | Novo Nordisk Investigational Site | Kansas City | Missouri |
| United States | Novo Nordisk Investigational Site | Lackland | Texas |
| United States | Novo Nordisk Investigational Site | Loma Linda | California |
| United States | Novo Nordisk Investigational Site | Long Beach | California |
| United States | Novo Nordisk Investigational Site | Los Angeles | California |
| United States | Novo Nordisk Investigational Site | Madison | Wisconsin |
| United States | Novo Nordisk Investigational Site | Memphis | Tennessee |
| United States | Novo Nordisk Investigational Site | Memphis | Tennessee |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Mineola | New York |
| United States | Novo Nordisk Investigational Site | Minneapolis | Minnesota |
| United States | Novo Nordisk Investigational Site | Mobile | Alabama |
| United States | Novo Nordisk Investigational Site | Morgantown | West Virginia |
| United States | Novo Nordisk Investigational Site | Morristown | New Jersey |
| United States | Novo Nordisk Investigational Site | New Haven | Connecticut |
| United States | Novo Nordisk Investigational Site | New Orleans | Louisiana |
| United States | Novo Nordisk Investigational Site | New York | New York |
| United States | Novo Nordisk Investigational Site | New York | New York |
| United States | Novo Nordisk Investigational Site | Norfolk | Virginia |
| United States | Novo Nordisk Investigational Site | Omaha | Nebraska |
| United States | Novo Nordisk Investigational Site | Omaha | Nebraska |
| United States | Novo Nordisk Investigational Site | Orlando | Florida |
| United States | Novo Nordisk Investigational Site | Paterson | New Jersey |
| United States | Novo Nordisk Investigational Site | Pensacola | Florida |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Phoenix | Arizona |
| United States | Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Portland | Oregon |
| United States | Novo Nordisk Investigational Site | Rochester | Minnesota |
| United States | Novo Nordisk Investigational Site | Rochester | New York |
| United States | Novo Nordisk Investigational Site | Sacramento | California |
| United States | Novo Nordisk Investigational Site | Salt Lake City | Utah |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Diego | California |
| United States | Novo Nordisk Investigational Site | San Diego | California |
| United States | Novo Nordisk Investigational Site | Spokane | Washington |
| United States | Novo Nordisk Investigational Site | Tallahassee | Florida |
| United States | Novo Nordisk Investigational Site | Tampa | Florida |
| United States | Novo Nordisk Investigational Site | Temple | Texas |
| United States | Novo Nordisk Investigational Site | Tucson | Arizona |
| United States | Novo Nordisk Investigational Site | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States,
Arslanian S, Foster C, Wright N, Stender S, Hu P, Hale P, Hale D. Comparison of Insulin Aspart, Regular Insulin, and Insulin Lispro in Basal Bolus Therapy with NPH To Treat Pediatric Patients with Type 1 Diabetes Mellitus. Diabetes 2005; 54 ((suppl 1)): A
Arslanian S, Foster C, Wright NM, Stender S, Hale P, Hale D. Insulin apart compared to regular insulin and insulin lispro in basal bolus therapy with NPH to treat pediatric patients with type 1 diabetes mellitus. EASD 2005 2005; 48(Suppl. 1): A327
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c (glycosylated haemoglobin A1c) | No | ||
| Secondary | FPG (fasting plasma glucose) | No |
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