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NCT00978627 · ClinicalTrials.gov registry record · Phase 3
Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
A Phase 3 study of Diabetes and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 548
- Enrollment target
- 20
- Study locations
NCT00978627 is a Phase 3 study of Diabetes and Diabetes Mellitus, Type 1 that has completed, run by Novo Nordisk A/S. The registered enrollment target is 548 participants, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT00978627, a Phase 3 study of Diabetes and Diabetes Mellitus, Type 1, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 548 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG insulin aspart
- DRUG insulin degludec/insulin aspart
- DRUG insulin detemir
Study Locations (20)
California
- Novo Nordisk Investigational Site - La Mesa
- Novo Nordisk Investigational Site - Lancaster
- Novo Nordisk Investigational Site - Mission Hills
- Novo Nordisk Investigational Site - North Hollywood
- Novo Nordisk Investigational Site - Salinas
- Novo Nordisk Investigational Site - Valencia
Georgia
- Novo Nordisk Investigational Site - Atlanta
- Novo Nordisk Investigational Site - Lawrenceville
- Novo Nordisk Investigational Site - Roswell
Florida
- Novo Nordisk Investigational Site - Miami
- Novo Nordisk Investigational Site - Miami
Minnesota
- Novo Nordisk Investigational Site - Eagan
- Novo Nordisk Investigational Site - Minneapolis
Colorado
- Novo Nordisk Investigational Site - Aurora
Hawaii
- Novo Nordisk Investigational Site - Honolulu
Illinois
- Novo Nordisk Investigational Site - Chicago
Kansas
- Novo Nordisk Investigational Site - Shawnee Mission
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 548 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00978627
The ClinicalTrials.gov registry entry for NCT00978627 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 548 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (82% lower). The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 3 interventions - of which insulin aspart is the first listed.
NCT00978627 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Georgia, Florida.
Frequently Asked Questions
What is clinical trial NCT00978627 about?
NCT00978627 is a clinical study titled "Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes". 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 extensio...
What is the current status of trial NCT00978627?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 548 participants. The study started on 2009-08. Estimated completion is 2010-05.
What conditions does trial NCT00978627 study?
This clinical trial studies the following conditions: Diabetes, Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT00978627?
The interventions under investigation include: insulin aspart (DRUG), insulin degludec/insulin aspart (DRUG), insulin detemir (DRUG).
Who is sponsoring clinical trial NCT00978627?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00978627 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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