Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes
Public ClinicalTrials.gov record NCT01045707. 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
NN5401-3590: A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™ : START 1) / NN5401-3726: An Extension Trial Comparing Safety and Efficacy of NN5401 With Insulin Glargine in Subjects With Type 2 Diabetes (BOOST™: START 1)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug). The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension period is registered as NN5401-3726.
Study identification
- NCT ID
- NCT01045707
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 530 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
- Jan 2010 (Type not available)
- Primary completion
- Oct 2010 (Actual)
- Completion
- Oct 2010 (Actual)
- Last update posted
- Dec 8, 2016
2010
United States locations
- U.S. sites
- 41
- U.S. states
- 20
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novo Nordisk Investigational Site | Birmingham | Alabama | 35233 | — |
| Novo Nordisk Investigational Site | Vestavia Hills | Alabama | 35209 | — |
| Novo Nordisk Investigational Site | Concord | California | 94520-1926 | — |
| Novo Nordisk Investigational Site | Greenbrae | California | 94904 | — |
| Novo Nordisk Investigational Site | Los Angeles | California | 90057 | — |
| Novo Nordisk Investigational Site | Waterbury | Connecticut | 06708 | — |
| Novo Nordisk Investigational Site | Miami | Florida | 33135 | — |
| Novo Nordisk Investigational Site | Miami | Florida | 33136 | — |
| Novo Nordisk Investigational Site | Miami | Florida | 33169 | — |
| Novo Nordisk Investigational Site | North Miami | Florida | 33161 | — |
| Novo Nordisk Investigational Site | Pembroke Pines | Florida | 33027 | — |
| Novo Nordisk Investigational Site | Honolulu | Hawaii | 96813 | — |
| Novo Nordisk Investigational Site | Honolulu | Hawaii | 96814 | — |
| Novo Nordisk Investigational Site | Idaho Falls | Idaho | 83404-7596 | — |
| Novo Nordisk Investigational Site | Council Bluffs | Iowa | 51501 | — |
| Novo Nordisk Investigational Site | Metairie | Louisiana | 70006-2930 | — |
| Novo Nordisk Investigational Site | New Orleans | Louisiana | 70119 | — |
| Novo Nordisk Investigational Site | Detroit | Michigan | 48235 | — |
| Novo Nordisk Investigational Site | Troy | Michigan | 48085-5524 | — |
| Novo Nordisk Investigational Site | Saint Charles | Missouri | 63303 | — |
| Novo Nordisk Investigational Site | Springfield | Missouri | 65807 | — |
| Novo Nordisk Investigational Site | Brooklyn | New York | 11203 | — |
| Novo Nordisk Investigational Site | Smithtown | New York | 11787 | — |
| Novo Nordisk Investigational Site | Greensboro | North Carolina | 27408 | — |
| Novo Nordisk Investigational Site | Greenville | North Carolina | 27834 | — |
| Novo Nordisk Investigational Site | Morehead City | North Carolina | 28557 | — |
| Novo Nordisk Investigational Site | Wilson | North Carolina | 27893 | — |
| Novo Nordisk Investigational Site | Tulsa | Oklahoma | 74104 | — |
| Novo Nordisk Investigational Site | Portland | Oregon | 97220 | — |
| Novo Nordisk Investigational Site | Portland | Oregon | 97239 | — |
| Novo Nordisk Investigational Site | Greer | South Carolina | 29651 | — |
| Novo Nordisk Investigational Site | Chattanooga | Tennessee | 37404 | — |
| Novo Nordisk Investigational Site | Memphis | Tennessee | 38119 | — |
| Novo Nordisk Investigational Site | Dallas | Texas | 75230 | — |
| Novo Nordisk Investigational Site | Dallas | Texas | 75235 | — |
| Novo Nordisk Investigational Site | Lubbock | Texas | 79423 | — |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78240 | — |
| Novo Nordisk Investigational Site | Tomball | Texas | 77375 | — |
| Novo Nordisk Investigational Site | St. George | Utah | 84790 | — |
| Novo Nordisk Investigational Site | Newport News | Virginia | 23606 | — |
| Novo Nordisk Investigational Site | Olympia | Washington | 98502 | — |
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 NCT01045707, 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 Dec 8, 2016 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01045707 live on ClinicalTrials.gov.