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NCT00306384 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety of Alogliptin in Patients With Type 2 Diabetes Mellitus
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,323
- Enrollment target
NCT00306384: Completed Phase 3 study, sponsored by Takeda.
NCT00306384 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 3,323 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (330% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00306384, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,323 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the long-term safety of alogliptin, once daily (QD), following participation in 1 of 7 controlled studies in patients with type 2 diabetes mellitus.
Primary Outcome
Safety was assessed by physical examinations, clinical laboratory parameters, electrocardiogram (ECG) readings, vital sign measurements, oral temperature, and hypoglycemic events. Changes in laboratory values or ECG parameters were considered to be adverse events if they were judged to be clinically significant. A TEAE was any event that started on or after the first dose of open-label study drug and within 14 days after the last dose.
Interventions
- DRUG Alogliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,323 participants |
| Start Date | 2006-03 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
What the finished NCT00306384 record still lists
NCT00306384 is an interventional study that assigns participants to a tested intervention. Its 3,323 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (330% higher).
The record links to 0 conditions, and to 1 intervention - of which Alogliptin is the first listed.
NCT00306384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00306384 about?
NCT00306384 is a clinical study titled "Long-term Safety of Alogliptin in Patients With Type 2 Diabetes Mellitus". The purpose of this study is to evaluate the long-term safety of alogliptin, once daily (QD), following participation in 1 of 7 controlled studies in patients with type 2 diabetes mellitus.
What is the current status of trial NCT00306384?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,323 participants. The study started on 2006-03. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00306384?
The interventions under investigation include: Alogliptin (DRUG).
Who is sponsoring clinical trial NCT00306384?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00306384's enrollment target sits among peer trials
3,323 72nd of 2000 higher than 1,929 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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