Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
Public ClinicalTrials.gov record NCT00736099. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 1356 (5 mg) as Monotherapy or in Combination With Other Antidiabetic Medications in Type 2 Diabetic Patients.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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)
Study identification
- NCT ID
- NCT00736099
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,122 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 82 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2008
- Primary completion
- Nov 30, 2010
- Completion
- Not listed
- Last update posted
- Jun 26, 2014
Started 2008
United States locations
- U.S. sites
- 13
- U.S. states
- 7
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1218.40.10003 Boehringer Ingelheim Investigational Site | Chula Vista | California | — | — |
| 1218.40.10014 Boehringer Ingelheim Investigational Site | Spring Valley | California | — | — |
| 1218.40.10001 Boehringer Ingelheim Investigational Site | Walnut Creek | California | — | — |
| 1218.40.10021 Boehringer Ingelheim Investigational Site | Northglenn | Colorado | — | — |
| 1218.40.10010 Boehringer Ingelheim Investigational Site | Hollywood | Florida | — | — |
| 1218.40.10011 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1218.40.10016 Boehringer Ingelheim Investigational Site | Eugene | Oregon | — | — |
| 1218.40.10002 Boehringer Ingelheim Investigational Site | Greer | South Carolina | — | — |
| 1218.40.10004 Boehringer Ingelheim Investigational Site | Simpsonville | South Carolina | — | — |
| 1218.40.10005 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1218.40.10018 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1218.40.10007 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1218.40.10009 Boehringer Ingelheim Investigational Site | Federal Way | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 219 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00736099, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 26, 2014 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00736099 live on ClinicalTrials.gov.