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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 2,122 participants.
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)
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00736099
The ClinicalTrials.gov registry entry for NCT00736099 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,122 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 2 interventions - of which linagliptine 5 mg is the first listed.
NCT00736099 reports 0 study locations.
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.
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