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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 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 413 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01388361
The ClinicalTrials.gov registry entry for NCT01388361 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 413 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which liraglutide is the first listed.
NCT01388361 reports 0 study locations.
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.
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