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NCT02121483 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT02121483: Completed Phase 1 study, sponsored by Boehringer Ingelheim.
NCT02121483 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02121483, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
The aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18 years with type 2 diabetes mellitus.
Primary Outcome
Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
Interventions
- DRUG empagliflozin medium dose
- DRUG empagliflozin high dose
- DRUG empagliflozin low dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2014-06 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
What the finished NCT02121483 record still lists
NCT02121483 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 3 interventions - of which empagliflozin medium dose is the first listed.
NCT02121483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02121483 about?
NCT02121483 is a clinical study titled "Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus". The aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18 years with type 2 diabetes mellitus.
What is the current status of trial NCT02121483?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2014-06. Estimated completion is 2016-02.
What interventions are being tested in trial NCT02121483?
The interventions under investigation include: empagliflozin medium dose (DRUG), empagliflozin high dose (DRUG), empagliflozin low dose (DRUG).
Who is sponsoring clinical trial NCT02121483?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02121483's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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