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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 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 302 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00328172
The ClinicalTrials.gov registry entry for NCT00328172 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 302 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 5 interventions - of which Placebo is the first listed.
NCT00328172 reports 0 study locations.
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.
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