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NCT01541215 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes
A Phase 3 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 135
- Enrollment target
NCT01541215: Completed Phase 3 study, sponsored by Novo Nordisk A/S.
NCT01541215 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 135 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01541215, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 135 participants
- Enrollment target
Study Summary
This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.
Primary Outcome
Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication.
Interventions
- DRUG placebo
- DRUG metformin
- DRUG liraglutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2012-11-13 |
| Est. Completion | 2020-05-20 |
| Phase | Phase 3 |
What the finished NCT01541215 record still lists
NCT01541215 is an interventional study that assigns participants to a tested intervention. The registered 135 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 (83% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01541215 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01541215 about?
NCT01541215 is a clinical study titled "Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes". This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.
What is the current status of trial NCT01541215?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 2012-11-13. Estimated completion is 2020-05-20.
What interventions are being tested in trial NCT01541215?
The interventions under investigation include: placebo (DRUG), metformin (DRUG), liraglutide (DRUG).
Who is sponsoring clinical trial NCT01541215?
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 NCT01541215's enrollment target sits among peer trials
135 1582nd of 2000 higher than 416 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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