Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients
Public ClinicalTrials.gov record NCT00328172. 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 Randomized, Double-blind, Placebo-controlled, Five Parallel Group Study Investigating the Efficacy and Safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg Administered Orally Once Daily) Over 12 Weeks in Drug Naive and Treated Patients With Type 2 Diabetes With Insufficient Glycemic Control (Study Includes an Open-label Metformin Treatment Arm)
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 several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.
Study identification
- NCT ID
- NCT00328172
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 302 participants
Conditions and interventions
Conditions
Interventions
- Placebo Drug
- BI 1356 dose 3 once daily Drug
- BI 1356 dose 2 once daily Drug
- BI 1356 dose 1 once daily Drug
- Metformin Drug
Drug
Eligibility (public fields only)
- Age range
- 21 Years to 75 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
- May 2006 (Type not available)
- Primary completion
- Aug 2007 (Actual)
- Completion
- Not listed
- Last update posted
- Mar 14, 2014
Started 2006
United States locations
- U.S. sites
- 34
- U.S. states
- 18
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1218.5.10020 Boehringer Ingelheim Investigational Site | Chula Vista | California | — | — |
| 1218.5.10001 Boehringer Ingelheim Investigational Site | La Jolla | California | — | — |
| 1218.5.10007 Boehringer Ingelheim Investigational Site | Walnut Creek | California | — | — |
| 1218.5.10041 Boehringer Ingelheim Investigational Site | Denver | Colorado | — | — |
| 1218.5.10018 Boehringer Ingelheim Investigational Site | Hollywood | Florida | — | — |
| 1218.5.10016 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | — | — |
| 1218.5.10003 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1218.5.10011 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1218.5.10012 Boehringer Ingelheim Investigational Site | Orlando | Florida | — | — |
| 1218.5.10017 Boehringer Ingelheim Investigational Site | Indianapolis | Indiana | — | — |
| 1218.5.10008 Boehringer Ingelheim Investigational Site | Topeka | Kansas | — | — |
| 1218.5.10024 Boehringer Ingelheim Investigational Site | Wichita | Kansas | — | — |
| 1218.5.10039 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | — | — |
| 1218.5.10032 Boehringer Ingelheim Investigational Site | Springfield | Massachusetts | — | — |
| 1218.5.10025 Boehringer Ingelheim Investigational Site | Chesterfield | Missouri | — | — |
| 1218.5.10034 Boehringer Ingelheim Investigational Site | Butte | Montana | — | — |
| 1218.5.10009 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | — | — |
| 1218.5.10042 Boehringer Ingelheim Investigational Site | Albany | New York | — | — |
| 1218.5.10029 Boehringer Ingelheim Investigational Site | Endwell | New York | — | — |
| 1218.5.10004 Boehringer Ingelheim Investigational Site | New Hyde Park | New York | — | — |
| 1218.5.10026 Boehringer Ingelheim Investigational Site | Columbus | Ohio | — | — |
| 1218.5.10035 Boehringer Ingelheim Investigational Site | Mentor | Ohio | — | — |
| 1218.5.10023 Boehringer Ingelheim Investigational Site | Medford | Oregon | — | — |
| 1218.5.10030 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | — | — |
| 1218.5.10044 Boehringer Ingelheim Investigational Site | Columbia | South Carolina | — | — |
| 1218.5.10033 Boehringer Ingelheim Investigational Site | Greer | South Carolina | — | — |
| 1218.5.10038 Boehringer Ingelheim Investigational Site | Simpsonville | South Carolina | — | — |
| 1218.5.10006 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1218.5.10040 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1218.5.10036 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1218.5.10021 Boehringer Ingelheim Investigational Site | Tyler | Texas | — | — |
| 1218.5.10027 Boehringer Ingelheim Investigational Site | Salem | Virginia | — | — |
| 1218.5.10022 Boehringer Ingelheim Investigational Site | Federal Way | Washington | — | — |
| 1218.5.10014 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 37 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00328172, 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 Mar 14, 2014 · Synced Oct 28, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00328172 live on ClinicalTrials.gov.