Search / Trial NCT00736099

Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
Launched by BOEHRINGER INGELHEIM · Aug 14, 2008

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Trial Information

Current as of August 11, 2025

Completed

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

Inclusion criteria:
• 1. Signed and dated written informed consent in accordance with the GCP and local legislation.
• 2. Patients completing the entire treatment period as a double blind trial whether or not they have been treated with rescue medication.
Exclusion criteria:
• 1. Patients who meet one or more of the withdrawal criteria of the treatment period of the previous trial.
2. Pre-menopausal women (last menstruation =\< 1 year prior to signing informed consent) who:
• are nursing or pregnant,
• or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence \[e.g. calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of birth control) and vasectomised partners. No exception will be made.
• 3. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation.
• 4. Drug abuse which, in the opinion of the investigator, would interfere with trial participation.
• 5. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.

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

Chula Vista, California, United States

Spring Valley, California, United States

Walnut Creek, California, United States

Northglenn, Colorado, United States

Hollywood, Florida, United States

Miami, Florida, United States

Eugene, Oregon, United States

Greer, South Carolina, United States

Simpsonville, South Carolina, United States

Dallas, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Federal Way, Washington, United States

Capital Federal, , Argentina

Mendoza, , Argentina

Parque Velez Sarfield, , Argentina

Graz, , Austria

Wien, , Austria

Brugge, , Belgium

Brussel, , Belgium

Edegem, , Belgium

Genk, , Belgium

Gent, , Belgium

Huy, , Belgium

Liège, , Belgium

Calgary, Alberta, Canada

Vancouver, British Columbia, Canada

Etobicoke, Ontario, Canada

Hamilton, Ontario, Canada

London, Ontario, Canada

Oakville, Ontario, Canada

Sarnia, Ontario, Canada

Strathroy, Ontario, Canada

Toronto, Ontario, Canada

Montague, , Canada

Saskatoon, Saskatchewan, Canada

Beijing, , China

Chengdu, , China

Dalian, , China

Guangzhou, , China

Haerbin, , China

Qingdao, , China

Shanghai, , China

Shenyang, , China

Wuhan, , China

Xi'an, , China

Krapinske Toplice, , Croatia

Slavonski Brod, , Croatia

Breclav, , Czech Republic

Brno, , Czech Republic

Hodonin, , Czech Republic

Olomouc, , Czech Republic

Helsinki, , Finland

Kuopio, , Finland

Oulu, , Finland

Seinäjoki, , Finland

Turku, , Finland

Bad Mergentheim, , Germany

Berlin, , Germany

Bosenheim, , Germany

Dresden, , Germany

Mainz, , Germany

Neuwied, , Germany

Nürnberg, , Germany

Saarbrücken, , Germany

Athens, , Greece

Nikaia, , Greece

Piraeus, , Greece

Thessaloniki, , Greece

Budapest, , Hungary

Debrecen, , Hungary

Györ, , Hungary

Szombathely, , Hungary

Andhra Pradesh, , India

Bangalore, , India

Chennai, , India

Hyderabad, Andra Pradesh, , India

Jaipur, , India

Kerala, , India

Maharashtra, , India

Mangalore, , India

Manipal, , India

Mumbai, , India

Nasik, , India

Uttar Pradesh, , India

Afula, , Israel

Haifa, , Israel

Holon, , Israel

Jerusalem, , Israel

Nahariya, , Israel

Safed, , Israel

Tel Aviv, , Israel

Genova, , Italy

Milano, , Italy

Pisa, , Italy

Roma, , Italy

Amagasaki, Hyogo, , Japan

Koganei, Tokyo, , Japan

Osaka, Osaka, , Japan

Shinjyuku Ku,Tokyo, , Japan

Suita, Osaka,, , Japan

Busan, , Korea, Republic Of

Daegu, , Korea, Republic Of

Incheon, , Korea, Republic Of

Jeonju, , Korea, Republic Of

Pusan, , Korea, Republic Of

Seoul, , Korea, Republic Of

Suwon, , Korea, Republic Of

Kelantan, , Malaysia

Kuala Lumpur, , Malaysia

Penang, , Malaysia

Perak, , Malaysia

Aguascalientes, Ags., , Mexico

Col.Americana, Guadalajara, Jalisco, , Mexico

Colonia Tlalpan, Mexico, , Mexico

Faccionamiento Lomas De Campestre,Aguascal, , Mexico

León, , Mexico

Monterrey N.L., , Mexico

Monterrey, , Mexico

México, , Mexico

Deurne, , Netherlands

Ewijk, , Netherlands

Losser, , Netherlands

Roelofarendsveen, , Netherlands

Wildervank, , Netherlands

Christchurch, , New Zealand

Dunedin, , New Zealand

Otahuhu, , New Zealand

Tauranga, , New Zealand

Wellington, , New Zealand

Greenhills, San Juan, , Philippines

Manila, , Philippines

Marikina, , Philippines

Pasig, , Philippines

Quezon City, , Philippines

Lublin, , Poland

Warsaw, , Poland

Zabrze, , Poland

Alba Iulia, , Romania

Brasov, , Romania

Bucharest, , Romania

Galati, , Romania

Sibiu, , Romania

Targu Mures, , Romania

Arkhangelsk, , Russian Federation

Moscow, , Russian Federation

Novosibirsk, , Russian Federation

Perm, , Russian Federation

Rostov On Don, , Russian Federation

Samara, , Russian Federation

St. Petersburg, , Russian Federation

Tomsk, , Russian Federation

Banska Bystrica, , Slovakia

Bratislava, , Slovakia

Nove Mesto, , Slovakia

Samorin, , Slovakia

Badalona, , Spain

Badia Del Vallés, , Spain

Borges Del Camp, , Spain

Centelles, , Spain

Granada, , Spain

L'hospitalet De Llobregat (Barcelona), , Spain

Madrid, , Spain

Sant Adrià Del Besós (Barcelona), , Spain

Sevilla, , Spain

Vic (Barcelona), , Spain

Härnösand, , Sweden

Malmö, , Sweden

Uddevalla, , Sweden

Uppsala, , Sweden

Changhua, , Taiwan

Taichung, , Taiwan

Tainan, , Taiwan

Taipei, , Taiwan

Taoyuan, , Taiwan

Bangkok, , Thailand

Khon Kaen, , Thailand

Dnepropetrovsk, , Ukraine

Kharkov, , Ukraine

Kiev, , Ukraine

Lvov, , Ukraine

Vinnitsa, , Ukraine

Zaporizhzhya, , Ukraine

Ashford, , United Kingdom

Baillieston, Glasgow, , United Kingdom

Bath, , United Kingdom

Burbage, , United Kingdom

Bury St Edmonds, , United Kingdom

Cardiff, , United Kingdom

Penarth, , United Kingdom

Reading, , United Kingdom

Waterloo, Liverpool, , United Kingdom

Montague, Prince Edward Island, Canada

Patients applied

0 patients applied

Trial Officials

Boehringer Ingelheim

Study Chair

Boehringer Ingelheim

Timeline

First submit

August 14, 2008

Trial launched

August 01, 2008

Trial updated

June 18, 2014

Estimated completion

Not reported

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Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM Launched by BOEHRINGER INGELHEIM · Aug 14, 2008

Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
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