Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT00097071
Collaborator
(none)
299
52
19
5.8
0.3
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
299 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Insulin Aspart Versus Insulin Lispro in Insulin Pumps in Children and Adolescents With Type 1 Diabetes
Study Start Date
:
Oct 1, 2004
Actual Primary Completion Date
:
May 1, 2006
Actual Study Completion Date
:
May 1, 2006
Outcome Measures
Primary Outcome Measures
- HbA1c [After 16 weeks treatment]
Secondary Outcome Measures
- Measurements of glycaemic control, safety parameters including frequency of hypoglycaemia, laboratory tests, clinical evaluations and adverse events []
Eligibility Criteria
Criteria
Ages Eligible for Study:
3 Years
to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Type 1 Diabetes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Mobile | Alabama | United States | 36617 |
| 2 | Novo Nordisk Investigational Site | Montgomery | Alabama | United States | 36106 |
| 3 | Novo Nordisk Investigational Site | Phoenix | Arizona | United States | 85016 |
| 4 | Novo Nordisk Investigational Site | Little Rock | Arkansas | United States | 72202 |
| 5 | Novo Nordisk Investigational Site | Loma Linda | California | United States | 92354 |
| 6 | Novo Nordisk Investigational Site | Sacramento | California | United States | 95816 |
| 7 | Novo Nordisk Investigational Site | San Diego | California | United States | 92123 |
| 8 | Novo Nordisk Investigational Site | Denver | Colorado | United States | 80262 |
| 9 | Novo Nordisk Investigational Site | Englewood | Colorado | United States | 80110 |
| 10 | Novo Nordisk Investigational Site | New Haven | Connecticut | United States | 06520 |
| 11 | Novo Nordisk Investigational Site | Orlando | Florida | United States | 32806-1101 |
| 12 | Novo Nordisk Investigational Site | St. Petersburg | Florida | United States | 33701 |
| 13 | Novo Nordisk Investigational Site | Tallahassee | Florida | United States | 32308 |
| 14 | Novo Nordisk Investigational Site | Atlanta | Georgia | United States | 30318 |
| 15 | Novo Nordisk Investigational Site | Idaho Falls | Idaho | United States | 83404-7596 |
| 16 | Novo Nordisk Investigational Site | Indianapolis | Indiana | United States | 46202-2879 |
| 17 | Novo Nordisk Investigational Site | Iowa City | Iowa | United States | 52242 |
| 18 | Novo Nordisk Investigational Site | Topeka | Kansas | United States | 66606 |
| 19 | Novo Nordisk Investigational Site | Wichita | Kansas | United States | 67226 |
| 20 | Novo Nordisk Investigational Site | Baton Rouge | Louisiana | United States | 70808 |
| 21 | Novo Nordisk Investigational Site | Baltimore | Maryland | United States | 21229 |
| 22 | Novo Nordisk Investigational Site | Baltimore | Maryland | United States | 21287 |
| 23 | Novo Nordisk Investigational Site | Boston | Massachusetts | United States | 02115 |
| 24 | Novo Nordisk Investigational Site | Boston | Massachusetts | United States | 02215 |
| 25 | Novo Nordisk Investigational Site | Springfield | Massachusetts | United States | 01107 |
| 26 | Novo Nordisk Investigational Site | Worcester | Massachusetts | United States | 01655 |
| 27 | Novo Nordisk Investigational Site | Detroit | Michigan | United States | 48202-2689 |
| 28 | Novo Nordisk Investigational Site | Minneapolis | Minnesota | United States | 55416 |
| 29 | Novo Nordisk Investigational Site | Minneapolis | Minnesota | United States | 55455 |
| 30 | Novo Nordisk Investigational Site | Kansas City | Missouri | United States | 64108 |
| 31 | Novo Nordisk Investigational Site | Omaha | Nebraska | United States | 68114 |
| 32 | Novo Nordisk Investigational Site | Omaha | Nebraska | United States | 68198-3020 |
| 33 | Novo Nordisk Investigational Site | Hackensack | New Jersey | United States | 07601 |
| 34 | Novo Nordisk Investigational Site | Bronx | New York | United States | 10467 |
| 35 | Novo Nordisk Investigational Site | Brooklyn | New York | United States | 11219 |
| 36 | Novo Nordisk Investigational Site | Buffalo | New York | United States | 14222 |
| 37 | Novo Nordisk Investigational Site | Manhasset | New York | United States | 11030 |
| 38 | Novo Nordisk Investigational Site | Asheville | North Carolina | United States | 28803 |
| 39 | Novo Nordisk Investigational Site | Chapel Hill | North Carolina | United States | 27599-7220 |
| 40 | Novo Nordisk Investigational Site | Columbus | Ohio | United States | 43203 |
| 41 | Novo Nordisk Investigational Site | Tulsa | Oklahoma | United States | 74136 |
| 42 | Novo Nordisk Investigational Site | Portland | Oregon | United States | 97239 |
| 43 | Novo Nordisk Investigational Site | Hershey | Pennsylvania | United States | 17033 |
| 44 | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | United States | 19107 |
| 45 | Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | United States | 15224 |
| 46 | Novo Nordisk Investigational Site | Charleston | South Carolina | United States | 29425 |
| 47 | Novo Nordisk Investigational Site | San Antonio | Texas | United States | 78229 |
| 48 | Novo Nordisk Investigational Site | San Antonio | Texas | United States | 78284 |
| 49 | Novo Nordisk Investigational Site | Norfolk | Virginia | United States | 23507 |
| 50 | Novo Nordisk Investigational Site | Seattle | Washington | United States | 98105 |
| 51 | Novo Nordisk Investigational Site | Charleston | West Virginia | United States | 25302 |
| 52 | Novo Nordisk Investigational Site | Milwaukee | Wisconsin | United States | 53226-0509 |
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:
NCT00097071
Other Study ID Numbers:
- ANA-2181
First Posted:
Nov 18, 2004
Last Update Posted:
Dec 22, 2016
Last Verified:
Dec 1, 2016
Keywords provided by Novo Nordisk A/S
Additional relevant MeSH terms: