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NCT00601250 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 701
- Enrollment target
NCT00601250: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00601250 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 701 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00601250, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 701 participants
- Enrollment target
Study Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
Primary Outcome
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Interventions
- DRUG linagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 701 participants |
| Start Date | 2008-01 |
| Phase | Phase 3 |
What the finished NCT00601250 record still lists
NCT00601250 is an interventional study that assigns participants to a tested intervention. The registered 701 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which linagliptin is the first listed.
NCT00601250 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00601250 about?
NCT00601250 is a clinical study titled "Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes". The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
What is the current status of trial NCT00601250?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 701 participants. The study started on 2008-01.
What interventions are being tested in trial NCT00601250?
The interventions under investigation include: linagliptin (DRUG).
Who is sponsoring clinical trial NCT00601250?
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 NCT00601250's enrollment target sits among peer trials
701 506th of 2000 higher than 1,495 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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