Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
Public ClinicalTrials.gov record NCT00978627. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
NN5401-3594: A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes / NN5401-3645: An Extension Trial Comparing Safety and Efficacy of NN5401 Plus Meal-time Insulin Aspart for the Remaining Meals With Insulin Detemir Plus Meal-time Insulin Aspart in Type 1 Diabetes (BOOST™: T1)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This trial is conducted in Europe, Oceania, and the United States of America (USA). The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart. The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.
Study identification
- NCT ID
- NCT00978627
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 548 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2009 (Type not available)
- Primary completion
- May 2010 (Actual)
- Completion
- May 2010 (Actual)
- Last update posted
- Mar 20, 2017
2009 – 2010
United States locations
- U.S. sites
- 30
- U.S. states
- 18
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novo Nordisk Investigational Site | La Mesa | California | 91942 | — |
| Novo Nordisk Investigational Site | Lancaster | California | 93534 | — |
| Novo Nordisk Investigational Site | Mission Hills | California | 91345 | — |
| Novo Nordisk Investigational Site | North Hollywood | California | 91606 | — |
| Novo Nordisk Investigational Site | Salinas | California | 93901 | — |
| Novo Nordisk Investigational Site | Valencia | California | 91355 | — |
| Novo Nordisk Investigational Site | Aurora | Colorado | 80045 | — |
| Novo Nordisk Investigational Site | Miami | Florida | 33156 | — |
| Novo Nordisk Investigational Site | Miami | Florida | 33169 | — |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30318 | — |
| Novo Nordisk Investigational Site | Lawrenceville | Georgia | 30046 | — |
| Novo Nordisk Investigational Site | Roswell | Georgia | 30076 | — |
| Novo Nordisk Investigational Site | Honolulu | Hawaii | 96814 | — |
| Novo Nordisk Investigational Site | Chicago | Illinois | 60607 | — |
| Novo Nordisk Investigational Site | Shawnee Mission | Kansas | 66204 | — |
| Novo Nordisk Investigational Site | Lexington | Kentucky | 40503 | — |
| Novo Nordisk Investigational Site | Eagan | Minnesota | 55123 | — |
| Novo Nordisk Investigational Site | Minneapolis | Minnesota | 55416 | — |
| Novo Nordisk Investigational Site | City of Saint Peters | Missouri | 63376 | — |
| Novo Nordisk Investigational Site | Butte | Montana | 59701 | — |
| Novo Nordisk Investigational Site | Omaha | Nebraska | 68131 | — |
| Novo Nordisk Investigational Site | Henderson | Nevada | 89052-2649 | — |
| Novo Nordisk Investigational Site | Albany | New York | 12206 | — |
| Novo Nordisk Investigational Site | Northport | New York | 11768 | — |
| Novo Nordisk Investigational Site | Morehead City | North Carolina | 28557 | — |
| Novo Nordisk Investigational Site | Greer | South Carolina | 29651 | — |
| Novo Nordisk Investigational Site | Dallas | Texas | 75390-9302 | — |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78215 | — |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78240 | — |
| Novo Nordisk Investigational Site | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 51 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00978627, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 20, 2017 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00978627 live on ClinicalTrials.gov.