Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes
Public ClinicalTrials.gov record NCT00601250. 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 Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT00601250
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 701 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 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
- Dec 31, 2007
- Primary completion
- Apr 30, 2009
- Completion
- Not listed
- Last update posted
- Jan 27, 2014
Started 2008
United States locations
- U.S. sites
- 19
- U.S. states
- 12
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1218.17.10003 Boehringer Ingelheim Investigational Site | Chula Vista | California | — | — |
| 1218.17.10014 Boehringer Ingelheim Investigational Site | Spring Valley | California | — | — |
| 1218.17.10001 Boehringer Ingelheim Investigational Site | Walnut Creek | California | — | — |
| 1218.17.10021 Boehringer Ingelheim Investigational Site | Northglenn | Colorado | — | — |
| 1218.17.10010 Boehringer Ingelheim Investigational Site | Hollywood | Florida | — | — |
| 1218.17.10011 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1218.17.10008 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | — | — |
| 1218.17.10017 Boehringer Ingelheim Investigational Site | Gurnee | Illinois | — | — |
| 1218.17.10006 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | — | — |
| 1218.17.10012 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina | — | — |
| 1218.17.10013 Boehringer Ingelheim Investigational Site | Mentor | Ohio | — | — |
| 1218.17.10015 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | — | — |
| 1218.17.10016 Boehringer Ingelheim Investigational Site | Eugene | Oregon | — | — |
| 1218.17.10002 Boehringer Ingelheim Investigational Site | Greer | South Carolina | — | — |
| 1218.17.10004 Boehringer Ingelheim Investigational Site | Simpsonville | South Carolina | — | — |
| 1218.17.10005 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1218.17.10018 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1218.17.10007 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1218.17.10009 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 63 non-U.S. sites.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00601250, 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 Jan 27, 2014 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00601250 live on ClinicalTrials.gov.