Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6832
Source ID: NCT00954447
Associated Drug: Placebo
Title: Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00954447/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Placebo|DRUG: Linagliptin
Outcome Measures: Primary: Change From Baseline in HbA1c After 24 Weeks, HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD), Baseline and 24 weeks | Secondary: Number of Patients With HbA1c < 7.0 Percent, 24 and 52 weeks|Number of Patients Lowering HbA1c by at Least 0.5 Percent, 24 and 52 weeks|Change From Baseline in HbA1c by Visit at Week 6, Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs, Baseline and 6 weeks|Change From Baseline in HbA1c by Visit at Week 12, Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs, Baseline and 12 weeks|Change From Baseline in HbA1c by Visit at Week 18, Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs, Baseline and 18 weeks|Change From Baseline in HbA1c by Visit at Week 32, Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs, Baseline and 32 weeks|Change From Baseline in HbA1c by Visit at Week 40, Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs, Baseline and 40 weeks|Change From Baseline in HbA1c by Visit at Week 52, Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs, Baseline and 52 weeks|Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment, Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs, Baseline and 24 weeks|Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment, Baseline and 52 weeks|Change From Baseline in FPG, Baseline, 6, 12, 18, 24, 32 and 40 weeks|Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment, Means adjusted for treatment, continous baseline HbA1c, continous baseline weight, continous baseline Insulin, categorical renal function impairment and concomitant OADs, Baseline and 52 weeks|Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment, Mean Daily Glucose was calculated using the 8-point blood glucose profile, Baseline, 24 and 52 weeks|Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment, Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner | Other: Number of Patients With HbA1c < 6.5 Percent, 24 and 52 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1263
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2009-08
Completion Date:
Results First Posted: 2012-09-27
Last Update Posted: 2013-12-30
Locations: 1218.36.01043 Boehringer Ingelheim Investigational Site, Escondido, California, United States|1218.36.01051 Boehringer Ingelheim Investigational Site, Escondido, California, United States|1218.36.01065 Boehringer Ingelheim Investigational Site, Fresno, California, United States|1218.36.01021 Boehringer Ingelheim Investigational Site, Greenbrae, California, United States|1218.36.01013 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States|1218.36.01048 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States|1218.36.01058 Boehringer Ingelheim Investigational Site, San Diego, California, United States|1218.36.01008 Boehringer Ingelheim Investigational Site, Santa Ana, California, United States|1218.36.01056 Boehringer Ingelheim Investigational Site, Waterbury, Connecticut, United States|1218.36.01054 Boehringer Ingelheim Investigational Site, Clearwater, Florida, United States|1218.36.01035 Boehringer Ingelheim Investigational Site, Inverness, Florida, United States|1218.36.01010 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1218.36.01042 Boehringer Ingelheim Investigational Site, New Port Richey, Florida, United States|1218.36.01063 Boehringer Ingelheim Investigational Site, Pembroke Pines, Florida, United States|1218.36.01037 Boehringer Ingelheim Investigational Site, Ponte Vedra, Florida, United States|1218.36.01032 Boehringer Ingelheim Investigational Site, St. Cloud, Florida, United States|1218.36.01049 Boehringer Ingelheim Investigational Site, St. Petersburg, Florida, United States|1218.36.01036 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States|1218.36.01047 Boehringer Ingelheim Investigational Site, Decatur, Georgia, United States|1218.36.01009 Boehringer Ingelheim Investigational Site, Roswell, Georgia, United States|1218.36.01055 Boehringer Ingelheim Investigational Site, Honolulu, Hawaii, United States|1218.36.01014 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States|1218.36.01011 Boehringer Ingelheim Investigational Site, Paducah, Kentucky, United States|1218.36.01040 Boehringer Ingelheim Investigational Site, Kansas City, Missouri, United States|1218.36.01029 Boehringer Ingelheim Investigational Site, St. Louis, Missouri, United States|1218.36.01034 Boehringer Ingelheim Investigational Site, St. Peters, Missouri, United States|1218.36.01018 Boehringer Ingelheim Investigational Site, Omaha, Nebraska, United States|1218.36.01053 Boehringer Ingelheim Investigational Site, New Hartford, New York, United States|1218.36.01006 Boehringer Ingelheim Investigational Site, Burlington, North Carolina, United States|1218.36.01025 Boehringer Ingelheim Investigational Site, Hickory, North Carolina, United States|1218.36.01005 Boehringer Ingelheim Investigational Site, Statesville, North Carolina, United States|1218.36.01015 Boehringer Ingelheim Investigational Site, Cincinnati, Ohio, United States|1218.36.01039 Boehringer Ingelheim Investigational Site, Tulsa, Oklahoma, United States|1218.36.01019 Boehringer Ingelheim Investigational Site, Altoona, Pennsylvania, United States|1218.36.01012 Boehringer Ingelheim Investigational Site, Norristown, Pennsylvania, United States|1218.36.01004 Boehringer Ingelheim Investigational Site, Greer, South Carolina, United States|1218.36.01020 Boehringer Ingelheim Investigational Site, Simpsonville, South Carolina, United States|1218.36.01003 Boehringer Ingelheim Investigational Site, Kingsport, Tennessee, United States|1218.36.01038 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States|1218.36.01016 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1218.36.01026 Boehringer Ingelheim Investigational Site, Salt Lake city, Utah, United States|1218.36.01041 Boehringer Ingelheim Investigational Site, Bennington, Vermont, United States|1218.36.01064 Boehringer Ingelheim Investigational Site, Richmond, Virginia, United States|1218.36.01024 Boehringer Ingelheim Investigational Site, Lakewood, Washington, United States|1218.36.01007 Boehringer Ingelheim Investigational Site, Renton, Washington, United States|1218.36.01027 Boehringer Ingelheim Investigational Site, Spokane, Washington, United States|1218.36.01062 Boehringer Ingelheim Investigational Site, Tacoma, Washington, United States|1218.36.54001 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1218.36.54002 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1218.36.54003 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1218.36.54005 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1218.36.54004 Boehringer Ingelheim Investigational Site, Córdoba, Argentina|1218.36.32002 Boehringer Ingelheim Investigational Site, Edegem, Belgium|1218.36.320099 Boehringer Ingelheim Investigational Site, Edegem, Belgium|1218.36.32006 Boehringer Ingelheim Investigational Site, Sint-Gillis-Waas, Belgium|1218.36.55003 Boehringer Ingelheim Investigational Site, Belém, Brazil|1218.36.55004 Boehringer Ingelheim Investigational Site, Porto Alegre, Brazil|1218.36.55001 Boehringer Ingelheim Investigational Site, São Paulo, Brazil|1218.36.55002 Boehringer Ingelheim Investigational Site, São Paulo, Brazil|1218.36.02010 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada|1218.36.02004 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada|1218.36.02011 Boehringer Ingelheim Investigational Site, Victoria, British Columbia, Canada|1218.36.02006 Boehringer Ingelheim Investigational Site, St. John's, Newfoundland and Labrador, Canada|1218.36.02002 Boehringer Ingelheim Investigational Site, Halifax, Nova Scotia, Canada|1218.36.02009 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada|1218.36.02005 Boehringer Ingelheim Investigational Site, Kingston, Ontario, Canada|1218.36.02008 Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada|1218.36.02007 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada|1218.36.02001 Boehringer Ingelheim Investigational Site, Laval, Quebec, Canada|1218.36.02003 Boehringer Ingelheim Investigational Site, Montreal, Quebec, Canada|1218.36.42006 Boehringer Ingelheim Investigational Site, Breclav, Czech Republic|1218.36.42004 Boehringer Ingelheim Investigational Site, Brno, Czech Republic|1218.36.42005 Boehringer Ingelheim Investigational Site, Hodonin, Czech Republic|1218.36.42002 Boehringer Ingelheim Investigational Site, Mlada Boleslav, Czech Republic|1218.36.42001 Boehringer Ingelheim Investigational Site, Neratovice, Czech Republic|1218.36.42007 Boehringer Ingelheim Investigational Site, Zlin, Czech Republic|1218.36.35807 Boehringer Ingelheim Investigational Site, Joensuu, Finland|1218.36.35802 Boehringer Ingelheim Investigational Site, Kuopio, Finland|1218.36.35803 Boehringer Ingelheim Investigational Site, Oulu, Finland|1218.36.35805 Boehringer Ingelheim Investigational Site, Tampere, Finland|1218.36.35804 Boehringer Ingelheim Investigational Site, Turku, Finland|1218.36.35806 Boehringer Ingelheim Investigational Site, Vantaa, Finland|1218.36.49001 Boehringer Ingelheim Investigational Site, Berlin, Germany|1218.36.49002 Boehringer Ingelheim Investigational Site, Berlin, Germany|1218.36.49010 Boehringer Ingelheim Investigational Site, Berlin, Germany|1218.36.49009 Boehringer Ingelheim Investigational Site, Bosenheim, Germany|1218.36.49004 Boehringer Ingelheim Investigational Site, Dortmund, Germany|1218.36.49006 Boehringer Ingelheim Investigational Site, Dresden, Germany|1218.36.49017 Boehringer Ingelheim Investigational Site, Köln, Germany|1218.36.49012 Boehringer Ingelheim Investigational Site, Magdeburg, Germany|1218.36.49005 Boehringer Ingelheim Investigational Site, Mainz, Germany|1218.36.49018 Boehringer Ingelheim Investigational Site, Neuwied, Germany|1218.36.49008 Boehringer Ingelheim Investigational Site, Pirna, Germany|1218.36.49019 Boehringer Ingelheim Investigational Site, Sulzbach-Rosenberg, Germany|1218.36.49003 Boehringer Ingelheim Investigational Site, Unterschneidheim, Germany|1218.36.49011 Boehringer Ingelheim Investigational Site, Wangen, Germany|1218.36.49014 Boehringer Ingelheim Investigational Site, Wangen, Germany|1218.36.49015 Boehringer Ingelheim Investigational Site, Westerkappeln, Germany|1218.36.30003 Boehringer Ingelheim Investigational Site, Athens, Greece|1218.36.30007 Boehringer Ingelheim Investigational Site, Athens, Greece|1218.36.30010 Boehringer Ingelheim Investigational Site, Athens, Greece|1218.36.30011 Boehringer Ingelheim Investigational Site, Larissa, Greece|1218.36.30002 Boehringer Ingelheim Investigational Site, Nikaia, Greece|1218.36.30005 Boehringer Ingelheim Investigational Site, Thessaloniki, Greece|1218.36.39002 Boehringer Ingelheim Investigational Site, Ferrara, Italy|1218.36.39003 Boehringer Ingelheim Investigational Site, Ferrara, Italy|1218.36.39004 Boehringer Ingelheim Investigational Site, Genova, Italy|1218.36.39005 Boehringer Ingelheim Investigational Site, Milano, Italy|1218.36.39001 Boehringer Ingelheim Investigational Site, Pordenone, Italy|1218.36.39007 Boehringer Ingelheim Investigational Site, Siena, Italy|1218.36.39006 Boehringer Ingelheim Investigational Site, Siracusa, Italy|1218.36.82004 Boehringer Ingelheim Investigational Site, Daegu, Korea, Republic of|1218.36.82009 Boehringer Ingelheim Investigational Site, Daegu, Korea, Republic of|1218.36.82008 Boehringer Ingelheim Investigational Site, Incheon, Korea, Republic of|1218.36.82007 Boehringer Ingelheim Investigational Site, Jeonju, Korea, Republic of|1218.36.82001 Boehringer Ingelheim Investigational Site, Pusan, Korea, Republic of|1218.36.82002 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1218.36.82003 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1218.36.82005 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1218.36.82006 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1218.36.82010 Boehringer Ingelheim Investigational Site, Suwon, Korea, Republic of|1218.36.52002 Boehringer Ingelheim Investigational Site, Pachuca, Mexico|1218.36.52004 Boehringer Ingelheim Investigational Site, San Luis Potosi, Mexico|1218.36.52005 Boehringer Ingelheim Investigational Site, Tijuana, Mexico|1218.36.31008 Boehringer Ingelheim Investigational Site, 's Hertogenbosch, Netherlands|1218.36.31001 Boehringer Ingelheim Investigational Site, Almere, Netherlands|1218.36.31006 Boehringer Ingelheim Investigational Site, Beek, Netherlands|1218.36.31002 Boehringer Ingelheim Investigational Site, Ewijk, Netherlands|1218.36.31004 Boehringer Ingelheim Investigational Site, Oude Pekela, Netherlands|1218.36.31007 Boehringer Ingelheim Investigational Site, Roelofarendsveen, Netherlands|1218.36.31005 Boehringer Ingelheim Investigational Site, Wildervank, Netherlands|1218.36.47002 Boehringer Ingelheim Investigational Site, Bergen, Norway|1218.36.47006 Boehringer Ingelheim Investigational Site, Elverum, Norway|1218.36.47005 Boehringer Ingelheim Investigational Site, Hamar, Norway|1218.36.47004 Boehringer Ingelheim Investigational Site, Oslo, Norway|1218.36.47001 Boehringer Ingelheim Investigational Site, Stavanger, Norway|1218.36.51003 Boehringer Ingelheim Investigational Site, Lima, Peru|1218.36.70002 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.36.70003 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.36.70001 Boehringer Ingelheim Investigational Site, Samara, Russian Federation|1218.36.70007 Boehringer Ingelheim Investigational Site, Smolensk, Russian Federation|1218.36.70005 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1218.36.70006 Boehringer Ingelheim Investigational Site, Yaroslavl, Russian Federation|1218.36.42103 Boehringer Ingelheim Investigational Site, Banska Bystrica, Slovakia|1218.36.42101 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia|1218.36.42102 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia|1218.36.42104 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia|1218.36.42105 Boehringer Ingelheim Investigational Site, Presov, Slovakia|1218.36.42106 Boehringer Ingelheim Investigational Site, Trebisov, Slovakia|1218.36.34002 Boehringer Ingelheim Investigational Site, Badia del Vallés (Barcelona), Spain|1218.36.34005 Boehringer Ingelheim Investigational Site, Barcelona, Spain|1218.36.34010 Boehringer Ingelheim Investigational Site, Barcelona, Spain|1218.36.34001 Boehringer Ingelheim Investigational Site, Bercelona, Spain|1218.36.34007 Boehringer Ingelheim Investigational Site, Borges del Camp (Tarragona), Spain|1218.36.34003 Boehringer Ingelheim Investigational Site, Centelles (Barcelona), Spain|1218.36.34004 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat (Barcelona), Spain|1218.36.34011 Boehringer Ingelheim Investigational Site, Sevilla, Spain|1218.36.34009 Boehringer Ingelheim Investigational Site, Tàrrega (Lleida), Spain|1218.36.34006 Boehringer Ingelheim Investigational Site, Vic (Barcelona), Spain|1218.36.88610 Boehringer Ingelheim Investigational Site, Changhua, Taiwan|1218.36.88607 Boehringer Ingelheim Investigational Site, Kaohsiung, Taiwan|1218.36.88601 Boehringer Ingelheim Investigational Site, Taichung, Taiwan|1218.36.88603 Boehringer Ingelheim Investigational Site, Taichung, Taiwan|1218.36.88606 Boehringer Ingelheim Investigational Site, Tainan, Taiwan|1218.36.88609 Boehringer Ingelheim Investigational Site, Taipei City, Taiwan|1218.36.88602 Boehringer Ingelheim Investigational Site, Taipei, Taiwan|1218.36.88604 Boehringer Ingelheim Investigational Site, Taipei, Taiwan|1218.36.88605 Boehringer Ingelheim Investigational Site, Taipei, Taiwan|1218.36.88608 Boehringer Ingelheim Investigational Site, Taipei, Taiwan
URL: https://clinicaltrials.gov/show/NCT00954447

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress