Search / Trial NCT00622284

Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes
Launched by BOEHRINGER INGELHEIM · Feb 22, 2008

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Trial Information

Current as of July 04, 2025

Completed

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

Inclusion criteria:
• 1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
• 2. Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
• 3. HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone
• 4. HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase
Exclusion criteria:
• 1. Myocardial infarction, stroke or transient ischemic attack (TIA)
• 2. Impaired hepatic function
• 3. Renal failure or renal impairment
• 4. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
• 5. Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within 3 months prior to screening

About Boehringer Ingelheim

Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.

Locations

Tempe, Arizona, United States

Chula Vista, California, United States

Los Angeles, California, United States

Los Gatos, California, United States

West Palm Beach, Florida, United States

Indianapolis, Indiana, United States

Topeka, Kansas, United States

St. Louis, Missouri, United States

Omaha, Nebraska, United States

Endwell, New York, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Mentor, Ohio, United States

Perrysburg, Ohio, United States

Oklahoma City, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Greer, South Carolina, United States

San Antonio, Texas, United States

Murray, Utah, United States

Salt Lake City, Utah, United States

Federal Way, Washington, United States

Renton, Washington, United States

Sofia, , Bulgaria

Stara Zagora, , Bulgaria

Aalborg, , Denmark

Aarhus C, , Denmark

Hvidovre, , Denmark

København Nv, , Denmark

Odense, , Denmark

Joué Les Tours Cedex, , France

Joué Les Tours, , France

Nantes Cedex 1, , France

Nantes, , France

Potigny, , France

Aschaffenburg, , Germany

Bad Mergentheim, , Germany

Berlin, , Germany

Bosenheim, , Germany

Dresden, , Germany

Flörsheim, , Germany

Frankfurt/Main, , Germany

Großheirath, , Germany

Haag, , Germany

Hamburg, , Germany

Hannover, , Germany

Hatten, , Germany

Kelkheim, , Germany

Köln, , Germany

Künzing, , Germany

Leipzig, , Germany

Neuwied, , Germany

Nürnberg, , Germany

Rednitzhembach, , Germany

Saaldorf Surheim, , Germany

Saarbrücken, , Germany

Speyer, , Germany

St. Ingbert/Oberwürzbach, , Germany

Sulzbach Rosenberg, , Germany

Unterschneidheim, , Germany

Wangen, , Germany

Westerkappeln, , Germany

Würzburg, , Germany

Hong Kong, , Hong Kong

Ajka, , Hungary

Baja, , Hungary

Békéscsaba, , Hungary

Hódmezövásárhely, , Hungary

Makó, , Hungary

Miskolc, , Hungary

Mosonmagyarovar, , Hungary

Szentes, , Hungary

Chennai, , India

Coimbatore, , India

Gujarat, , India

Hyderabad, , India

Kochi, , India

Mumbai, , India

Patna, , India

Tamilnadu, , India

Co. Cork, , Ireland

Co. Wexford, , Ireland

Dublin, , Ireland

Waterford, , Ireland

Catania, , Italy

Chieti, , Italy

Codogno (Lo), , Italy

Genova, , Italy

Perugia, , Italy

Pordenone, , Italy

Ravenna, , Italy

Roma, , Italy

Siena, , Italy

'S Hertogenbosch, , Netherlands

Almere, , Netherlands

Beek En Donk, , Netherlands

Ewijk, , Netherlands

Hoogwoud, , Netherlands

Oude Pekela, , Netherlands

Rilland, , Netherlands

Roelofarendsveen, , Netherlands

Wildervank, , Netherlands

Fevik, , Norway

Fornebu, , Norway

Hamar, , Norway

Rud, , Norway

Sandvika, , Norway

Bialystok, , Poland

Gdynia, , Poland

Krakow, , Poland

Lodz, , Poland

Olsztyn, , Poland

Torun, , Poland

Warsaw, , Poland

Bellville, , South Africa

Cape Town, , South Africa

Durban, , South Africa

Lenasia, , South Africa

Pretoria, , South Africa

Göteborg, , Sweden

Malmö, , Sweden

Uppsala, , Sweden

Baillieston, Glasgow, , United Kingdom

Blackpool, , United Kingdom

Bradford On Avon, , United Kingdom

Buckshaw Village, Chorley, , United Kingdom

Cheadle, , United Kingdom

Chestfield, Whitstable, , United Kingdom

Chippenham, , United Kingdom

Dundee, , United Kingdom

Edgbaston, Birmingham, , United Kingdom

Ely, , United Kingdom

Guildford, , United Kingdom

Manchester, , United Kingdom

Trowbridge, , United Kingdom

Waterloo, Liverpool, , United Kingdom

Westbury, , United Kingdom

Whitstable, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Boehringer Ingelheim

Study Chair

Boehringer Ingelheim

Timeline

First submit

February 13, 2008

Trial launched

February 01, 2008

Trial updated

December 11, 2013

Estimated completion

Not reported

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Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes Launched by BOEHRINGER INGELHEIM · Feb 22, 2008

Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes
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