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NCT00736099 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,122
- Enrollment target
NCT00736099: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00736099 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 2,122 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (175% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00736099, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,122 participants
- Enrollment target
Study Summary
The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment. The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin in combination with a sulphonylurea (patients in 1218.18 study)
Primary Outcome
This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
Interventions
- DRUG linagliptine 5 mg
- DRUG linagliptine 5 mg and pioglitazone 30 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,122 participants |
| Start Date | 2008-08 |
| Phase | Phase 3 |
What the finished NCT00736099 record still lists
NCT00736099 is an interventional study that assigns participants to a tested intervention. Its 2,122 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 (175% higher).
The record links to 0 conditions, and to 2 interventions - of which linagliptine 5 mg is the first listed.
NCT00736099 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00736099 about?
NCT00736099 is a clinical study titled "Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM". The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment. The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI...
What is the current status of trial NCT00736099?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,122 participants. The study started on 2008-08.
What interventions are being tested in trial NCT00736099?
The interventions under investigation include: linagliptine 5 mg (DRUG), linagliptine 5 mg and pioglitazone 30 mg (DRUG).
Who is sponsoring clinical trial NCT00736099?
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 NCT00736099's enrollment target sits among peer trials
2,122 98th of 2000 higher than 1,903 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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