Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes
Public ClinicalTrials.gov record NCT00622284. 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, Active-controlled Parallel Group Efficacy and Safety Study of BI 1356 ( 5.0 mg, Administered Orally Once Daily) Compared to Glimepiride Over Two Years 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 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
Study identification
- NCT ID
- NCT00622284
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,560 participants
Conditions and interventions
Conditions
Interventions
- Placebo identical to BI 1356 5mg Drug
- Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg Drug
- BI 1356 Drug
- Glimepiride Drug
Drug
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
- Feb 2008 (Type not available)
- Primary completion
- Dec 2010 (Actual)
- Completion
- Not listed
- Last update posted
- Jan 29, 2014
Started 2008
United States locations
- U.S. sites
- 23
- U.S. states
- 15
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1218.20.10033 Boehringer Ingelheim Investigational Site | Tempe | Arizona | — | — |
| 1218.20.10003 Boehringer Ingelheim Investigational Site | Chula Vista | California | — | — |
| 1218.20.10020 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1218.20.10035 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1218.20.10037 Boehringer Ingelheim Investigational Site | Los Gatos | California | — | — |
| 1218.20.10034 Boehringer Ingelheim Investigational Site | West Palm Beach | Florida | — | — |
| 1218.20.10023 Boehringer Ingelheim Investigational Site | Indianapolis | Indiana | — | — |
| 1218.20.10030 Boehringer Ingelheim Investigational Site | Topeka | Kansas | — | — |
| 1218.20.10028 Boehringer Ingelheim Investigational Site | St Louis | Missouri | — | — |
| 1218.20.10006 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | — | — |
| 1218.20.10022 Boehringer Ingelheim Investigational Site | Endwell | New York | — | — |
| 1218.20.10032 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | — | — |
| 1218.20.10031 Boehringer Ingelheim Investigational Site | Columbus | Ohio | — | — |
| 1218.20.10013 Boehringer Ingelheim Investigational Site | Mentor | Ohio | — | — |
| 1218.20.10045 Boehringer Ingelheim Investigational Site | Perrysburg | Ohio | — | — |
| 1218.20.10042 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | — | — |
| 1218.20.10024 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | — | — |
| 1218.20.10002 Boehringer Ingelheim Investigational Site | Greer | South Carolina | — | — |
| 1218.20.10007 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1218.20.10036 Boehringer Ingelheim Investigational Site | Murray | Utah | — | — |
| 1218.20.10029 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | — | — |
| 1218.20.10009 Boehringer Ingelheim Investigational Site | Federal Way | Washington | — | — |
| 1218.20.10026 Boehringer Ingelheim Investigational Site | Renton | 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 198 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00622284, 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 29, 2014 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00622284 live on ClinicalTrials.gov.