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NCT01342484 · ClinicalTrials.gov registry record · Phase 2
Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT01342484: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT01342484 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01342484, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
The main objective of this study is to identify the dose of linagliptin in paediatric patients. Other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of treatment. Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD) and the PK/PD relationship of linagliptin in the paediatric population.
Primary Outcome
Change from baseline in Glycosylated haemoglobin (HbA1c) \[%\] after 12 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest.
Interventions
- DRUG placebo
- DRUG BI1356 low dose
- DRUG BI1356 high dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-04 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
What the finished NCT01342484 record still lists
NCT01342484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01342484 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01342484 about?
NCT01342484 is a clinical study titled "Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes". The main objective of this study is to identify the dose of linagliptin in paediatric patients. Other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of treatment. Furthermore,...
What is the current status of trial NCT01342484?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2011-04. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01342484?
The interventions under investigation include: placebo (DRUG), BI1356 low dose (DRUG), BI1356 high dose (DRUG).
Who is sponsoring clinical trial NCT01342484?
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 NCT01342484's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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