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NCT01388361 · ClinicalTrials.gov registry record · Phase 3
Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin
A Phase 3 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 413
- Enrollment target
NCT01388361: Completed Phase 3 study, sponsored by Novo Nordisk A/S.
NCT01388361 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 413 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01388361, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 413 participants
- Enrollment target
Study Summary
This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes. Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin treatment.
Primary Outcome
Values for change in HbA1c from baseline to 26 weeks of treatment period.
Interventions
- DRUG liraglutide
- DRUG insulin aspart
- DRUG insulin degludec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 413 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-07 |
| Phase | Phase 3 |
What the finished NCT01388361 record still lists
NCT01388361 is an interventional study that assigns participants to a tested intervention. The registered 413 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 (47% lower).
The record links to 0 conditions, and to 3 interventions - of which liraglutide is the first listed.
NCT01388361 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01388361 about?
NCT01388361 is a clinical study titled "Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin". This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes. Eligible subjects with an HbA1c equal to or above 7% a...
What is the current status of trial NCT01388361?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 413 participants. The study started on 2011-09. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01388361?
The interventions under investigation include: liraglutide (DRUG), insulin aspart (DRUG), insulin degludec (DRUG).
Who is sponsoring clinical trial NCT01388361?
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 NCT01388361's enrollment target sits among peer trials
413 905th of 2000 higher than 1,095 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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