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NCT01365507 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens
A Phase 3 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 276
- Enrollment target
NCT01365507: Completed Phase 3 study, sponsored by Novo Nordisk A/S.
NCT01365507 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 276 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01365507, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 276 participants
- Enrollment target
Study Summary
This trial is conducted in Asia and North America. The aim of this trial is to compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve subjects with type 2 diabetes mellitus when using two different titration algorithms (dose individually adjusted) as add-on to subject's ongoing treatment with metformin.
Primary Outcome
Change from baseline in HbA1c after 26 weeks of treatment.
Interventions
- DRUG insulin degludec/insulin aspart
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
What the finished NCT01365507 record still lists
NCT01365507 is an interventional study that assigns participants to a tested intervention. The registered 276 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 (64% lower).
The record links to 0 conditions, and to 1 intervention - of which insulin degludec/insulin aspart is the first listed.
NCT01365507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01365507 about?
NCT01365507 is a clinical study titled "Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens". This trial is conducted in Asia and North America. The aim of this trial is to compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve subjects with type 2 diabetes mellitus when using two different titration algorithms (dose individually adjusted) as...
What is the current status of trial NCT01365507?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2011-06. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01365507?
The interventions under investigation include: insulin degludec/insulin aspart (DRUG).
Who is sponsoring clinical trial NCT01365507?
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 NCT01365507's enrollment target sits among peer trials
276 1202nd of 2000 higher than 795 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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