Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT00071448
Collaborator
(none)
378
76
24
5
0.2
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
378 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date
:
Jun 1, 2002
Actual Primary Completion Date
:
Jun 1, 2004
Actual Study Completion Date
:
Jun 1, 2004
Outcome Measures
Primary Outcome Measures
- HbA1c (glycosylated haemoglobin A1c) []
Secondary Outcome Measures
- FPG (fasting plasma glucose) []
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Years
to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Birmingham | Alabama | United States | 35294 |
| 2 | Novo Nordisk Investigational Site | Mobile | Alabama | United States | 36617 |
| 3 | Novo Nordisk Investigational Site | Phoenix | Arizona | United States | 85013 |
| 4 | Novo Nordisk Investigational Site | Tucson | Arizona | United States | 85712 |
| 5 | Novo Nordisk Investigational Site | Loma Linda | California | United States | 92354 |
| 6 | Novo Nordisk Investigational Site | Long Beach | California | United States | 90806 |
| 7 | Novo Nordisk Investigational Site | Los Angeles | California | United States | 90027 |
| 8 | Novo Nordisk Investigational Site | Sacramento | California | United States | 95817 |
| 9 | Novo Nordisk Investigational Site | San Diego | California | United States | 92093 |
| 10 | Novo Nordisk Investigational Site | San Diego | California | United States | 92123 |
| 11 | Novo Nordisk Investigational Site | Englewood | Colorado | United States | 80110 |
| 12 | Novo Nordisk Investigational Site | Hartford | Connecticut | United States | 06106 |
| 13 | Novo Nordisk Investigational Site | New Haven | Connecticut | United States | 06520 |
| 14 | Novo Nordisk Investigational Site | Gainesville | Florida | United States | 32605 |
| 15 | Novo Nordisk Investigational Site | Gainesville | Florida | United States | 32608 |
| 16 | Novo Nordisk Investigational Site | Miami | Florida | United States | 33136 |
| 17 | Novo Nordisk Investigational Site | Orlando | Florida | United States | 32806-1101 |
| 18 | Novo Nordisk Investigational Site | Pensacola | Florida | United States | 32504 |
| 19 | Novo Nordisk Investigational Site | Tallahassee | Florida | United States | 32308 |
| 20 | Novo Nordisk Investigational Site | Tampa | Florida | United States | 33612 |
| 21 | Novo Nordisk Investigational Site | Atlanta | Georgia | United States | 30342 |
| 22 | Novo Nordisk Investigational Site | Idaho Falls | Idaho | United States | 83404-7596 |
| 23 | Novo Nordisk Investigational Site | Indianapolis | Indiana | United States | 46202-2879 |
| 24 | Novo Nordisk Investigational Site | Indianapolis | Indiana | United States | 46250 |
| 25 | Novo Nordisk Investigational Site | Iowa City | Iowa | United States | 52242 |
| 26 | Novo Nordisk Investigational Site | Baton Rouge | Louisiana | United States | 70808 |
| 27 | Novo Nordisk Investigational Site | New Orleans | Louisiana | United States | 70127-5430 |
| 28 | Novo Nordisk Investigational Site | Baltimore | Maryland | United States | 21201 |
| 29 | Novo Nordisk Investigational Site | Baltimore | Maryland | United States | 21229 |
| 30 | Novo Nordisk Investigational Site | Boston | Massachusetts | United States | 02115 |
| 31 | Novo Nordisk Investigational Site | Boston | Massachusetts | United States | 02215 |
| 32 | Novo Nordisk Investigational Site | Worcester | Massachusetts | United States | 01655 |
| 33 | Novo Nordisk Investigational Site | Ann Arbor | Michigan | United States | 48109 |
| 34 | Novo Nordisk Investigational Site | Minneapolis | Minnesota | United States | 55416 |
| 35 | Novo Nordisk Investigational Site | Rochester | Minnesota | United States | 55905 |
| 36 | Novo Nordisk Investigational Site | Kansas City | Missouri | United States | 64108 |
| 37 | Novo Nordisk Investigational Site | Omaha | Nebraska | United States | 68114 |
| 38 | Novo Nordisk Investigational Site | Omaha | Nebraska | United States | 68198-3020 |
| 39 | Novo Nordisk Investigational Site | Hackensack | New Jersey | United States | 07601 |
| 40 | Novo Nordisk Investigational Site | Morristown | New Jersey | United States | 07962 |
| 41 | Novo Nordisk Investigational Site | Paterson | New Jersey | United States | 07503 |
| 42 | Novo Nordisk Investigational Site | Albuquerque | New Mexico | United States | 87102 |
| 43 | Novo Nordisk Investigational Site | Albany | New York | United States | 12208 |
| 44 | Novo Nordisk Investigational Site | Brooklyn | New York | United States | 11219 |
| 45 | Novo Nordisk Investigational Site | Buffalo | New York | United States | 53226 |
| 46 | Novo Nordisk Investigational Site | Mineola | New York | United States | 11501 |
| 47 | Novo Nordisk Investigational Site | New York | New York | United States | 10022 |
| 48 | Novo Nordisk Investigational Site | New York | New York | United States | 10029 |
| 49 | Novo Nordisk Investigational Site | Rochester | New York | United States | 14642 |
| 50 | Novo Nordisk Investigational Site | Chapel Hill | North Carolina | United States | 27599-7220 |
| 51 | Novo Nordisk Investigational Site | Akron | Ohio | United States | 44308-1062 |
| 52 | Novo Nordisk Investigational Site | Cleveland | Ohio | United States | 44195 |
| 53 | Novo Nordisk Investigational Site | Columbus | Ohio | United States | 43231 |
| 54 | Novo Nordisk Investigational Site | Dayton | Ohio | United States | 45404 |
| 55 | Novo Nordisk Investigational Site | Portland | Oregon | United States | 97227 |
| 56 | Novo Nordisk Investigational Site | Danville | Pennsylvania | United States | 17822 |
| 57 | Novo Nordisk Investigational Site | Erie | Pennsylvania | United States | 16507 |
| 58 | Novo Nordisk Investigational Site | Hershey | Pennsylvania | United States | 17033 |
| 59 | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | United States | 19104 |
| 60 | Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | United States | 15213-3417 |
| 61 | Novo Nordisk Investigational Site | Charleston | South Carolina | United States | 29425 |
| 62 | Novo Nordisk Investigational Site | Columbia | South Carolina | United States | 29203 |
| 63 | Novo Nordisk Investigational Site | Greer | South Carolina | United States | 29651 |
| 64 | Novo Nordisk Investigational Site | Memphis | Tennessee | United States | 38103 |
| 65 | Novo Nordisk Investigational Site | Memphis | Tennessee | United States | 38119 |
| 66 | Novo Nordisk Investigational Site | Corpus Christi | Texas | United States | 78411 |
| 67 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75235 |
| 68 | Novo Nordisk Investigational Site | Lackland | Texas | United States | 78236 |
| 69 | Novo Nordisk Investigational Site | San Antonio | Texas | United States | 78229 |
| 70 | Novo Nordisk Investigational Site | San Antonio | Texas | United States | 78284 |
| 71 | Novo Nordisk Investigational Site | Temple | Texas | United States | 76508 |
| 72 | Novo Nordisk Investigational Site | Salt Lake City | Utah | United States | 84132 |
| 73 | Novo Nordisk Investigational Site | Norfolk | Virginia | United States | 23510 |
| 74 | Novo Nordisk Investigational Site | Spokane | Washington | United States | 99201 |
| 75 | Novo Nordisk Investigational Site | Morgantown | West Virginia | United States | 26506 |
| 76 | Novo Nordisk Investigational Site | Madison | Wisconsin | United States | 53792 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00071448
Other Study ID Numbers:
- ANA-2126
First Posted:
Oct 24, 2003
Last Update Posted:
Dec 22, 2016
Last Verified:
Dec 1, 2016
Additional relevant MeSH terms: