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Completed Phase 3 Interventional Results available

A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate

ClinicalTrials.gov ID: NCT00740051

Public ClinicalTrials.gov record NCT00740051. 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.

ClinicalTrials.gov public records Last synced Oct 28, 2026, 8:28 AM EDT

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, db, Placebo-controlled, Parallel Group Efficacy and Safety Study of BI 1356 (5mg), Administered Orally Once Daily for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients With Insufficient Glycaemic Control for Whom Metformin Therapy is Inappropriate (Intolerability or Contraindication)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)

Study identification

NCT ID
NCT00740051
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
227 participants

Conditions and interventions

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
Aug 2008 (Type not available)
Primary completion
Aug 2010 (Actual)
Completion
Not listed
Last update posted
Jun 27, 2014

Started 2008

United States locations

U.S. sites
15
U.S. states
9
U.S. cities
13
Facility City State ZIP Site status
1218.50.10009 Boehringer Ingelheim Investigational Site Birmingham Alabama — —
1218.50.10011 Boehringer Ingelheim Investigational Site Peoria Arizona — —
1218.50.10013 Boehringer Ingelheim Investigational Site Greenbrae California — —
1218.50.10016 Boehringer Ingelheim Investigational Site Harbor City California — —
1218.50.10017 Boehringer Ingelheim Investigational Site Huntington Park California — —
1218.50.10006 Boehringer Ingelheim Investigational Site Los Angeles California — —
1218.50.10007 Boehringer Ingelheim Investigational Site Miami Florida — —
1218.50.10004 Boehringer Ingelheim Investigational Site Statesville North Carolina — —
1218.50.10002 Boehringer Ingelheim Investigational Site Eugene Oregon — —
1218.50.10015 Boehringer Ingelheim Investigational Site Greer South Carolina — —
1218.50.10005 Boehringer Ingelheim Investigational Site Kingsport Tennessee — —
1218.50.10012 Boehringer Ingelheim Investigational Site Dallas Texas — —
1218.50.10022 Boehringer Ingelheim Investigational Site Dallas Texas — —
1218.50.10010 Boehringer Ingelheim Investigational Site San Antonio Texas — —
1218.50.10018 Boehringer Ingelheim Investigational Site San Antonio Texas — —

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 38 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00740051, 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 27, 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 NCT00740051 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →