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NCT01045707 · ClinicalTrials.gov registry record · Phase 3
Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes
A Phase 3 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 530
- Enrollment target
NCT01045707: Completed Phase 3 study, sponsored by Novo Nordisk A/S.
NCT01045707 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 530 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01045707, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 530 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Change from baseline in HbA1c after 26 weeks of treatment.
Interventions
- DRUG insulin glargine
- DRUG insulin degludec/insulin aspart
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 530 participants |
| Start Date | 2010-01 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
What the finished NCT01045707 record still lists
NCT01045707 is an interventional study that assigns participants to a tested intervention. The registered 530 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 2 interventions - of which insulin glargine is the first listed.
NCT01045707 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01045707 about?
NCT01045707 is a clinical study titled "Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes". 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...
What is the current status of trial NCT01045707?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 530 participants. The study started on 2010-01. Estimated completion is 2010-10.
What interventions are being tested in trial NCT01045707?
The interventions under investigation include: insulin glargine (DRUG), insulin degludec/insulin aspart (DRUG).
Who is sponsoring clinical trial NCT01045707?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01045707's enrollment target sits among peer trials
530 706th of 2000 higher than 1,292 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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