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

June 18, 2014 updated by: Boehringer Ingelheim

A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 1356 (5 mg) as Monotherapy or in Combination With Other Antidiabetic Medications in Type 2 Diabetic Patients.

The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment.

The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin in combination with a sulphonylurea (patients in 1218.18 study)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2122

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Capital Federal, Argentina
        • 1218.40.54002 Boehringer Ingelheim Investigational Site
      • Capital Federal, Argentina
        • 1218.40.54010 Boehringer Ingelheim Investigational Site
      • Mendoza, Argentina
        • 1218.40.54011 Boehringer Ingelheim Investigational Site
      • Parque Velez Sarfield, Argentina
        • 1218.40.54015 Boehringer Ingelheim Investigational Site
  • Austria
      • Graz, Austria
        • 1218.40.43001 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1218.40.43005 Boehringer Ingelheim Investigational Site
  • Belgium
      • Brugge, Belgium
        • 1218.40.32005 Boehringer Ingelheim Investigational Site
      • Brussel, Belgium
        • 1218.40.32007 Boehringer Ingelheim Investigational Site
      • Edegem, Belgium
        • 1218.40.32006 Boehringer Ingelheim Investigational Site
      • Genk, Belgium
        • 1218.40.32004 Boehringer Ingelheim Investigational Site
      • Gent, Belgium
        • 1218.40.32003 Boehringer Ingelheim Investigational Site
      • Huy, Belgium
        • 1218.40.32002 Boehringer Ingelheim Investigational Site
      • Liège, Belgium
        • 1218.40.32001 Boehringer Ingelheim Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • 1218.40.01005 Boehringer Ingelheim Investigational Site
      • Calgary, Alberta, Canada
        • 1218.40.01010 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 1218.40.01003 Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Canada
        • 1218.40.01011 Boehringer Ingelheim Investigational Site
    • Ontario
      • Etobicoke, Ontario, Canada
        • 1218.40.01006 Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, Canada
        • 1218.40.01009 Boehringer Ingelheim Investigational Site
      • London, Ontario, Canada
        • 1218.40.01002 Boehringer Ingelheim Investigational Site
      • Oakville, Ontario, Canada
        • 1218.40.01012 Boehringer Ingelheim Investigational Site
      • Sarnia, Ontario, Canada
        • 1218.40.01008 Boehringer Ingelheim Investigational Site
      • Strathroy, Ontario, Canada
        • 1218.40.20005 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1218.40.01001 Boehringer Ingelheim Investigational Site
    • Prince Edward Island
      • Montague, Prince Edward Island, Canada
        • 1218.40.01004 Boehringer Ingelheim Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • 1218.40.01007 Boehringer Ingelheim Investigational Site
  • China
      • Beijing, China
        • 1218.40.86001 Boehringer Ingelheim Investigational Site
      • Beijing, China
        • 1218.40.86002 Boehringer Ingelheim Investigational Site
      • Beijing, China
        • 1218.40.86004 Boehringer Ingelheim Investigational Site
      • Chengdu, China
        • 1218.40.86013 Boehringer Ingelheim Investigational Site
      • Dalian, China
        • 1218.40.86009 Boehringer Ingelheim Investigational Site
      • Guangzhou, China
        • 1218.40.86011 Boehringer Ingelheim Investigational Site
      • Haerbin, China
        • 1218.40.86014 Boehringer Ingelheim Investigational Site
      • Qingdao, China
        • 1218.40.86008 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1218.40.86015 Boehringer Ingelheim Investigational Site
      • Shenyang, China
        • 1218.40.86010 Boehringer Ingelheim Investigational Site
      • Wuhan, China
        • 1218.40.86007 Boehringer Ingelheim Investigational Site
      • Wuhan, China
        • 1218.40.86012 Boehringer Ingelheim Investigational Site
      • Xi'An, China
        • 1218.40.86006 Boehringer Ingelheim Investigational Site
  • Croatia
      • Krapinske Toplice, Croatia
        • 1218.40.38605 Boehringer Ingelheim Investigational Site
      • Slavonski Brod, Croatia
        • 1218.40.38604 Boehringer Ingelheim Investigational Site
  • Czech Republic
      • Breclav, Czech Republic
        • 1218.40.42006 Boehringer Ingelheim Investigational Site
      • Brno, Czech Republic
        • 1218.40.42004 Boehringer Ingelheim Investigational Site
      • Brno, Czech Republic
        • 1218.40.42007 Boehringer Ingelheim Investigational Site
      • Brno, Czech Republic
        • 1218.40.42009 Boehringer Ingelheim Investigational Site
      • Hodonin, Czech Republic
        • 1218.40.42008 Boehringer Ingelheim Investigational Site
      • Olomouc, Czech Republic
        • 1218.40.42003 Boehringer Ingelheim Investigational Site
  • Finland
      • Helsinki, Finland
        • 1218.40.35806 Boehringer Ingelheim Investigational Site
      • Kuopio, Finland
        • 1218.40.35801 Boehringer Ingelheim Investigational Site
      • Oulu, Finland
        • 1218.40.35803 Boehringer Ingelheim Investigational Site
      • Seinäjoki, Finland
        • 1218.40.35805 Boehringer Ingelheim Investigational Site
      • Turku, Finland
        • 1218.40.35802 Boehringer Ingelheim Investigational Site
  • Germany
      • Bad Mergentheim, Germany
        • 1218.40.49028 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1218.40.49022 Boehringer Ingelheim Investigational Site
      • Bosenheim, Germany
        • 1218.40.49024 Boehringer Ingelheim Investigational Site
      • Dresden, Germany
        • 1218.40.49020 Boehringer Ingelheim Investigational Site
      • Mainz, Germany
        • 1218.40.49101 Boehringer Ingelheim Investigational Site
      • Neuwied, Germany
        • 1218.40.49003 Boehringer Ingelheim Investigational Site
      • Nürnberg, Germany
        • 1218.40.49007 Boehringer Ingelheim Investigational Site
      • Saarbrücken, Germany
        • 1218.40.49014 Boehringer Ingelheim Investigational Site
  • Greece
      • Athens, Greece
        • 1218.40.30004 Boehringer Ingelheim Investigational Site
      • Athens, Greece
        • 1218.40.30007 Boehringer Ingelheim Investigational Site
      • Athens, Greece
        • 1218.40.30013 Boehringer Ingelheim Investigational Site
      • Nikaia, Greece
        • 1218.40.30003 Boehringer Ingelheim Investigational Site
      • Piraeus, Greece
        • 1218.40.30011 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Greece
        • 1218.40.30006 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Greece
        • 1218.40.30016 Boehringer Ingelheim Investigational Site
  • Hungary
      • Budapest, Hungary
        • 1218.40.36003 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1218.40.36004 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1218.40.36006 Boehringer Ingelheim Investigational Site
      • Debrecen, Hungary
        • 1218.40.36008 Boehringer Ingelheim Investigational Site
      • Györ, Hungary
        • 1218.40.36005 Boehringer Ingelheim Investigational Site
      • Szombathely, Hungary
        • 1218.40.36002 Boehringer Ingelheim Investigational Site
  • India
      • Andhra Pradesh, India
        • 1218.40.91010 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1218.40.91002 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1218.40.91005 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 1218.40.91012 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 1218.40.91014 Boehringer Ingelheim Investigational Site
      • Hyderabad, Andra Pradesh, India
        • 1218.40.91009 Boehringer Ingelheim Investigational Site
      • Jaipur, India
        • 1218.40.91006 Boehringer Ingelheim Investigational Site
      • Kerala, India
        • 1218.40.91001 Boehringer Ingelheim Investigational Site
      • Maharashtra, India
        • 1218.40.91011 Boehringer Ingelheim Investigational Site
      • Mangalore, India
        • 1218.40.91008 Boehringer Ingelheim Investigational Site
      • Manipal, India
        • 1218.40.91007 Boehringer Ingelheim Investigational Site
      • Mumbai, India
        • 1218.40.91004 Boehringer Ingelheim Investigational Site
      • Nasik, India
        • 1218.40.91003 Boehringer Ingelheim Investigational Site
      • Uttar Pradesh, India
        • 1218.40.91013 Boehringer Ingelheim Investigational Site
  • Israel
      • Afula, Israel
        • 1218.40.97274 Boehringer Ingelheim Investigational Site
      • Haifa, Israel
        • 1218.40.97273 Boehringer Ingelheim Investigational Site
      • Holon, Israel
        • 1218.40.97275 Boehringer Ingelheim Investigational Site
      • Jerusalem, Israel
        • 1218.40.97271 Boehringer Ingelheim Investigational Site
      • Nahariya, Israel
        • 1218.40.97272 Boehringer Ingelheim Investigational Site
      • Safed, Israel
        • 1218.40.97276 Boehringer Ingelheim Investigational Site
      • Tel Aviv, Israel
        • 1218.40.97278 Boehringer Ingelheim Investigational Site
  • Italy
      • Genova, Italy
        • 1218.40.39008 Boehringer Ingelheim Investigational Site
      • Milano, Italy
        • 1218.40.39002 Boehringer Ingelheim Investigational Site
      • Pisa, Italy
        • 1218.40.39001 Boehringer Ingelheim Investigational Site
      • Roma, Italy
        • 1218.40.39006 Boehringer Ingelheim Investigational Site
  • Japan
      • Amagasaki, Hyogo, Japan
        • 1218.40.81001 Boehringer Ingelheim Investigational Site
      • Koganei, Tokyo, Japan
        • 1218.40.81005 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japan
        • 1218.40.81002 Boehringer Ingelheim Investigational Site
      • Shinjyuku-ku,Tokyo, Japan
        • 1218.40.81004 Boehringer Ingelheim Investigational Site
      • Suita, Osaka,, Japan
        • 1218.40.81003 Boehringer Ingelheim Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of
        • 1218.40.82002 Boehringer Ingelheim Investigational Site
      • Daegu, Korea, Republic of
        • 1218.40.82011 Boehringer Ingelheim Investigational Site
      • Incheon, Korea, Republic of
        • 1218.40.82008 Boehringer Ingelheim Investigational Site
      • Jeonju, Korea, Republic of
        • 1218.40.82010 Boehringer Ingelheim Investigational Site
      • Pusan, Korea, Republic of
        • 1218.40.82004 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1218.40.82001 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1218.40.82005 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1218.40.82006 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1218.40.82007 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1218.40.82009 Boehringer Ingelheim Investigational Site
      • Suwon, Korea, Republic of
        • 1218.40.82003 Boehringer Ingelheim Investigational Site
  • Malaysia
      • Kelantan, Malaysia
        • 1218.40.60003 Boehringer Ingelheim Investigational Site
      • Kuala Lumpur, Malaysia
        • 1218.40.60001 Boehringer Ingelheim Investigational Site
      • Kuala Lumpur, Malaysia
        • 1218.40.60002 Boehringer Ingelheim Investigational Site
      • Penang, Malaysia
        • 1218.40.60007 Boehringer Ingelheim Investigational Site
      • Perak, Malaysia
        • 1218.40.60004 Boehringer Ingelheim Investigational Site
      • Perak, Malaysia
        • 1218.40.60005 Boehringer Ingelheim Investigational Site
  • Mexico
      • Aguascalientes, Ags., Mexico
        • 1218.40.52007 Boehringer Ingelheim Investigational Site
      • Col.Americana, Guadalajara, Jalisco, Mexico
        • 1218.40.52010 Boehringer Ingelheim Investigational Site
      • Colonia Tlalpan, mexico, Mexico
        • 1218.40.52008 Boehringer Ingelheim Investigational Site
      • Faccionamiento Lomas de Campestre,AGUASCAL, Mexico
        • 1218.40.52006 Boehringer Ingelheim Investigational Site
      • León, Mexico
        • 1218.40.52009 Boehringer Ingelheim Investigational Site
      • Monterrey, Mexico
        • 1218.40.52003 Boehringer Ingelheim Investigational Site
      • Monterrey N.L., Mexico
        • 1218.40.52001 Boehringer Ingelheim Investigational Site
      • México, Mexico
        • 1218.40.52002 Boehringer Ingelheim Investigational Site
      • México, Mexico
        • 1218.40.52004 Boehringer Ingelheim Investigational Site
      • México, Mexico
        • 1218.40.52005 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Deurne, Netherlands
        • 1218.40.31006 Boehringer Ingelheim Investigational Site
      • Ewijk, Netherlands
        • 1218.40.31001 Boehringer Ingelheim Investigational Site
      • Losser, Netherlands
        • 1218.40.31010 Boehringer Ingelheim Investigational Site
      • Roelofarendsveen, Netherlands
        • 1218.40.31008 Boehringer Ingelheim Investigational Site
      • Wildervank, Netherlands
        • 1218.40.31002 Boehringer Ingelheim Investigational Site
  • New Zealand
      • Christchurch, New Zealand
        • 1218.40.64004 Boehringer Ingelheim Investigational Site
      • Dunedin, New Zealand
        • 1218.40.64003 Boehringer Ingelheim Investigational Site
      • Otahuhu, New Zealand
        • 1218.40.64002 Boehringer Ingelheim Investigational Site
      • Tauranga, New Zealand
        • 1218.40.64001 Boehringer Ingelheim Investigational Site
      • Wellington, New Zealand
        • 1218.40.64005 Boehringer Ingelheim Investigational Site
  • Philippines
      • Greenhills, San Juan, Philippines
        • 1218.40.63003 Boehringer Ingelheim Investigational Site
      • Manila, Philippines
        • 1218.40.63005 Boehringer Ingelheim Investigational Site
      • Marikina, Philippines
        • 1218.40.63002 Boehringer Ingelheim Investigational Site
      • Pasig, Philippines
        • 1218.40.63001 Boehringer Ingelheim Investigational Site
      • Quezon City, Philippines
        • 1218.40.63004 Boehringer Ingelheim Investigational Site
  • Poland
      • Lublin, Poland
        • 1218.40.48603 Boehringer Ingelheim Investigational Site
      • Warsaw, Poland
        • 1218.40.48601 Boehringer Ingelheim Investigational Site
      • Zabrze, Poland
        • 1218.40.48604 Boehringer Ingelheim Investigational Site
  • Romania
      • Alba Iulia, Romania
        • 1218.40.40504 Boehringer Ingelheim Investigational Site
      • Brasov, Romania
        • 1218.40.40604 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 1218.40.40501 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 1218.40.40502 Boehringer Ingelheim Investigational Site
      • Galati, Romania
        • 1218.40.40603 Boehringer Ingelheim Investigational Site
      • Sibiu, Romania
        • 1218.40.40503 Boehringer Ingelheim Investigational Site
      • Targu-Mures, Romania
        • 1218.40.40505 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Arkhangelsk, Russian Federation
        • 1218.40.70014 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1218.40.70001 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1218.40.70002 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1218.40.70003 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1218.40.70012 Boehringer Ingelheim Investigational Site
      • Novosibirsk, Russian Federation
        • 1218.40.70005 Boehringer Ingelheim Investigational Site
      • Perm, Russian Federation
        • 1218.40.70006 Boehringer Ingelheim Investigational Site
      • Rostov-on-Don, Russian Federation
        • 1218.40.70013 Boehringer Ingelheim Investigational Site
      • Samara, Russian Federation
        • 1218.40.70016 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1218.40.70015 Boehringer Ingelheim Investigational Site
      • Tomsk, Russian Federation
        • 1218.40.70004 Boehringer Ingelheim Investigational Site
  • Slovakia
      • Banska Bystrica, Slovakia
        • 1218.40.42103 Boehringer Ingelheim Investigational Site
      • Bratislava, Slovakia
        • 1218.40.42102 Boehringer Ingelheim Investigational Site
      • Bratislava, Slovakia
        • 1218.40.42104 Boehringer Ingelheim Investigational Site
      • Bratislava, Slovakia
        • 1218.40.42105 Boehringer Ingelheim Investigational Site
      • Nove Mesto, Slovakia
        • 1218.40.42101 Boehringer Ingelheim Investigational Site
      • Samorin, Slovakia
        • 1218.40.42106 Boehringer Ingelheim Investigational Site
  • Spain
      • Badalona, Spain
        • 1218.40.34002 Boehringer Ingelheim Investigational Site
      • Badia del Vallés, Spain
        • 1218.40.34011 Boehringer Ingelheim Investigational Site
      • Borges del Camp, Spain
        • 1218.40.34012 Boehringer Ingelheim Investigational Site
      • Centelles, Spain
        • 1218.40.34013 Boehringer Ingelheim Investigational Site
      • Granada, Spain
        • 1218.40.34007 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat (Barcelona), Spain
        • 1218.40.34008 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat (Barcelona), Spain
        • 1218.40.34009 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1218.40.34004 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1218.40.34006 Boehringer Ingelheim Investigational Site
      • Sant Adrià del Besós (Barcelona), Spain
        • 1218.40.34010 Boehringer Ingelheim Investigational Site
      • Sevilla, Spain
        • 1218.40.34005 Boehringer Ingelheim Investigational Site
      • Vic (Barcelona), Spain
        • 1218.40.34014 Boehringer Ingelheim Investigational Site
  • Sweden
      • Härnösand, Sweden
        • 1218.40.46013 Boehringer Ingelheim Investigational Site
      • Malmö, Sweden
        • 1218.40.46001 Boehringer Ingelheim Investigational Site
      • Uddevalla, Sweden
        • 1218.40.46012 Boehringer Ingelheim Investigational Site
      • Uppsala, Sweden
        • 1218.40.46004 Boehringer Ingelheim Investigational Site
  • Taiwan
      • ChangHua, Taiwan
        • 1218.40.88605 Boehringer Ingelheim Investigational Site
      • Taichung, Taiwan
        • 1218.40.88604 Boehringer Ingelheim Investigational Site
      • Tainan, Taiwan
        • 1218.40.88606 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1218.40.88601 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1218.40.88602 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1218.40.88603 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1218.40.88607 Boehringer Ingelheim Investigational Site
      • Taoyuan, Taiwan
        • 1218.40.88608 Boehringer Ingelheim Investigational Site
  • Thailand
      • Bangkok, Thailand
        • 1218.40.66001 Boehringer Ingelheim Investigational Site
      • Khon Kaen, Thailand
        • 1218.40.66002 Boehringer Ingelheim Investigational Site
  • Ukraine
      • Dnepropetrovsk, Ukraine
        • 1218.40.38011 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraine
        • 1218.40.38002 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraine
        • 1218.40.38004 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraine
        • 1218.40.38010 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1218.40.38001 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1218.40.38005 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1218.40.38008 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1218.40.38009 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1218.40.38012 Boehringer Ingelheim Investigational Site
      • Lvov, Ukraine
        • 1218.40.38003 Boehringer Ingelheim Investigational Site
      • Vinnitsa, Ukraine
        • 1218.40.38006 Boehringer Ingelheim Investigational Site
      • Zaporizhzhya, Ukraine
        • 1218.40.38007 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Ashford, United Kingdom
        • 1218.40.44005 Boehringer Ingelheim Investigational Site
      • Baillieston, Glasgow, United Kingdom
        • 1218.40.44004 Boehringer Ingelheim Investigational Site
      • Bath, United Kingdom
        • 1218.40.44001 Boehringer Ingelheim Investigational Site
      • Burbage, United Kingdom
        • 1218.40.44003 Boehringer Ingelheim Investigational Site
      • Bury St Edmonds, United Kingdom
        • 1218.40.44010 Boehringer Ingelheim Investigational Site
      • Cardiff, United Kingdom
        • 1218.40.44009 Boehringer Ingelheim Investigational Site
      • Penarth, United Kingdom
        • 1218.40.44002 Boehringer Ingelheim Investigational Site
      • Reading, United Kingdom
        • 1218.40.44006 Boehringer Ingelheim Investigational Site
      • Waterloo, Liverpool, United Kingdom
        • 1218.40.44007 Boehringer Ingelheim Investigational Site
  • United States
    • California
      • Chula Vista, California, United States
        • 1218.40.10003 Boehringer Ingelheim Investigational Site
      • Spring Valley, California, United States
        • 1218.40.10014 Boehringer Ingelheim Investigational Site
      • Walnut Creek, California, United States
        • 1218.40.10001 Boehringer Ingelheim Investigational Site
    • Colorado
      • Northglenn, Colorado, United States
        • 1218.40.10021 Boehringer Ingelheim Investigational Site
    • Florida
      • Hollywood, Florida, United States
        • 1218.40.10010 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1218.40.10011 Boehringer Ingelheim Investigational Site
    • Oregon
      • Eugene, Oregon, United States
        • 1218.40.10016 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Greer, South Carolina, United States
        • 1218.40.10002 Boehringer Ingelheim Investigational Site
      • Simpsonville, South Carolina, United States
        • 1218.40.10004 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, United States
        • 1218.40.10005 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1218.40.10018 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1218.40.10007 Boehringer Ingelheim Investigational Site
    • Washington
      • Federal Way, Washington, United States
        • 1218.40.10009 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: linagliptin 5 mg
open label
Drug: linagliptine 5 mg
safety and efficacy of linagliptine 5 mg open label
Experimental: linagliptin 5 mg and pioglitazone 30 mg
open label
Drug: linagliptine 5 mg and pioglitazone 30 mg
efficacy and safety of the combination linagliptine and pioglitazone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Patients With Adverse Events (AEs)
Time Frame: 78 weeks
This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
78 weeks
Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events
Time Frame: 78 weeks
78 weeks
Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)
Time Frame: 78 weeks
As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis'').
78 weeks
Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events
Time Frame: 78 weeks
Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)
78 weeks
Number of Patients With Abnormalities in Vital Signs
Time Frame: 78 weeks
Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)
78 weeks
Number of Patients With Abnormalities in Haematology: Eosinophils
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.
78 weeks
Number of Patients With Abnormalities in Haematology: Haemoglobin
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients.
78 weeks
Number of Patients With Abnormalities in Haematology: Haematocrit
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.
78 weeks
Number of Patients With Abnormalities in Haematology: Red Blood Cell Count
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^12/L.
78 weeks
Number of Patients With Abnormalities in Haematology: White Blood Cell Count
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^9/L (decrease) or a value greater than 20.1 * 10^9/L (increase).
78 weeks
Number of Patients With Abnormalities in Haematology: Platelets
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as value less than or equal to 75 * 10^9/L (decrease) or a value greater than or equal to 700 * 10^9/L (increase).
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Potassium
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase).
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients.
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Amylase
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN).
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT)
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Creatinine
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL.
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Phosphate
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase).
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Calcium
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase).
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Sodium
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 130 mmol/L (decrease) or a value greater than 160 mmol/L (increase).
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Glucose
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL.
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL.
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN.
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Albumin
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL.
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol
Time Frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.
78 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c From Baseline to Week 6
Time Frame: Baseline and week 6
Baseline and week 6
Change in HbA1c From Baseline to Week 18
Time Frame: Baseline and week 18
Baseline and week 18
Change in HbA1c From Baseline to Week 30
Time Frame: Baseline and week 30
Baseline and week 30
Change in HbA1c From Baseline to Week 42
Time Frame: Baseline and week 42
Baseline and week 42
Change in HbA1c From Baseline to Week 54
Time Frame: Baseline and week 54
Baseline and week 54
Change in HbA1c From Baseline to Week 66
Time Frame: Baseline and week 66
Baseline and week 66
Change in HbA1c From Baseline to Week 78
Time Frame: Baseline and week 78
Baseline and week 78
Number of Patients With HbA1c<7.0% Over Time
Time Frame: 78 weeks
78 weeks
Number of Patients With HbA1c<6.5% Over Time
Time Frame: 78 weeks
78 weeks
Number of Patients With Lowered HbA1c by at Least 0.5% Over Time
Time Frame: 78 weeks
78 weeks
Change in FPG From Baseline to Week 6
Time Frame: Baseline and week 6
Baseline and week 6
Change in FPG From Baseline to Week 18
Time Frame: Baseline and week 18
Baseline and week 18
Change in FPG From Baseline to Week 30
Time Frame: Baseline and week 30
Baseline and week 30
Change in FPG From Baseline to Week 42
Time Frame: Baseline and week 42
Baseline and week 42
Change in FPG From Baseline to Week 54
Time Frame: Baseline and week 54
Baseline and week 54
Change in FPG From Baseline to Week 66
Time Frame: Baseline and week 66
Baseline and week 66
Change in FPG From Baseline to Week 78
Time Frame: Baseline and week 78
Baseline and week 78

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (Estimate)

August 15, 2008

Study Record Updates

Last Update Posted (Estimate)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 18, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1218.40
  • 2008-000750-13 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on linagliptine 5 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe