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NCT00328172 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 302
- Enrollment target
NCT00328172: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT00328172 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 302 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (127% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00328172, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 302 participants
- Enrollment target
Study Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.
Primary Outcome
The change from baseline reflects the Week 12 HbA1c minus the Week 0 HbA1c. Means are adjusted for baseline HbA1c.
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG BI 1356 dose 3 once daily
- DRUG BI 1356 dose 2 once daily
- DRUG BI 1356 dose 1 once daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2006-05 |
| Phase | Phase 2 |
What the finished NCT00328172 record still lists
NCT00328172 is an interventional study that assigns participants to a tested intervention. The registered 302 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (127% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00328172 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00328172 about?
NCT00328172 is a clinical study titled "Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients". The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-la...
What is the current status of trial NCT00328172?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 302 participants. The study started on 2006-05.
What interventions are being tested in trial NCT00328172?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), BI 1356 dose 3 once daily (DRUG), BI 1356 dose 2 once daily (DRUG), BI 1356 dose 1 once daily (DRUG).
Who is sponsoring clinical trial NCT00328172?
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 NCT00328172's enrollment target sits among peer trials
302 167th of 2000 higher than 1,834 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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