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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 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01342484
The ClinicalTrials.gov registry entry for NCT01342484 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01342484 reports 0 study locations.
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.
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