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Clinical Trial Details

Trial ID: L5116
Source ID: NCT01512979
Associated Drug: Metformin
Title: Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01512979/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: metformin|DRUG: linagliptin|DRUG: metformin placebo|DRUG: metformin placebo
Outcome Measures: Primary: Change From Baseline in HbA1c After 24 Weeks, HbA1c is measured as a percentage. The change from baseline is the Week 24 HbA1c minus the baseline HbA1c. Means are adjusted for treatment and continuous baseline HbA1c, Baseline and 24 weeks | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment, The change from baseline is the FPG after 24 weeks minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose., Baseline and 24 weeks|Change From Baseline in HbA1c by Visit Over Time, HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes treatment, continuous baseline HbA1c in addition to week repeated within patient, week by baseline HbA1c interaction and week by treatment interaction., Baseline, 6, 12, 18 and 24 weeks|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment), The proportion of patients who achieved HbA1c lowering by at least 0.5% after 24 weeks of treatment.The model includes treatment, and continuous baseline HbA1c., Baseline and 24 weeks|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 1.0% After 24 Weeks of Treatment), The proportion of patients who achieved HbA1c lowering by at least 1.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c., Baseline and 24 weeks|Occurrence of Treat to Target Efficacy Response (HbA1c <7.0%) After 24 Weeks of Treatment, The proportion of patients who achieved HbA1c below 7.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c., Baseline and 24 weeks|Change From Baseline in FPG by Visit Over Time, The change from baseline is the FPG over time minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c, continuous baseline FPG in addition to week repeated within patient, week by baseline FPG interaction and week by treatment interaction., Baseline, 6, 12, 18 and 24 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 316
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2012-01
Completion Date: 2013-04
Results First Posted: 2014-05-09
Last Update Posted: 2014-05-20
Locations: 1218.83.11002 Boehringer Ingelheim Investigational Site, Phoenix, Arizona, United States|1218.83.11036 Boehringer Ingelheim Investigational Site, Little Rock, Arkansas, United States|1218.83.11011 Boehringer Ingelheim Investigational Site, Chino, California, United States|1218.83.11001 Boehringer Ingelheim Investigational Site, Huntington Beach, California, United States|1218.83.11019 Boehringer Ingelheim Investigational Site, Huntington Park, California, United States|1218.83.11015 Boehringer Ingelheim Investigational Site, Lomita, California, United States|1218.83.11023 Boehringer Ingelheim Investigational Site, Norwalk, California, United States|1218.83.11014 Boehringer Ingelheim Investigational Site, Roseville, California, United States|1218.83.11031 Boehringer Ingelheim Investigational Site, San Diego, California, United States|1218.83.11022 Boehringer Ingelheim Investigational Site, Fort Lauderdale, Florida, United States|1218.83.11025 Boehringer Ingelheim Investigational Site, Orlando, Florida, United States|1218.83.11033 Boehringer Ingelheim Investigational Site, Sanford, Florida, United States|1218.83.11029 Boehringer Ingelheim Investigational Site, Oakwood, Georgia, United States|1218.83.11026 Boehringer Ingelheim Investigational Site, Owensboro, Kentucky, United States|1218.83.11008 Boehringer Ingelheim Investigational Site, Elkton, Maryland, United States|1218.83.11027 Boehringer Ingelheim Investigational Site, Freemont, Nebraska, United States|1218.83.11005 Boehringer Ingelheim Investigational Site, Edison, New Jersey, United States|1218.83.11013 Boehringer Ingelheim Investigational Site, Jacksonville, North Carolina, United States|1218.83.11028 Boehringer Ingelheim Investigational Site, Salisbury, North Carolina, United States|1218.83.11009 Boehringer Ingelheim Investigational Site, Shelby, North Carolina, United States|1218.83.11003 Boehringer Ingelheim Investigational Site, Franklin, Ohio, United States|1218.83.11024 Boehringer Ingelheim Investigational Site, Gallipolis, Ohio, United States|1218.83.11018 Boehringer Ingelheim Investigational Site, Columbia, South Carolina, United States|1218.83.11004 Boehringer Ingelheim Investigational Site, Bristol, Tennessee, United States|1218.83.11017 Boehringer Ingelheim Investigational Site, Chattanooga, Tennessee, United States|1218.83.11032 Boehringer Ingelheim Investigational Site, Grand Prairie, Texas, United States|1218.83.11030 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1218.83.11034 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States|1218.83.11021 Boehringer Ingelheim Investigational Site, Tomball, Texas, United States|1218.83.12011 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada|1218.83.12007 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada|1218.83.12001 Boehringer Ingelheim Investigational Site, Red Deer, Alberta, Canada|1218.83.12002 Boehringer Ingelheim Investigational Site, Paradise, Newfoundland and Labrador, Canada|1218.83.12009 Boehringer Ingelheim Investigational Site, St. John's, Newfoundland and Labrador, Canada|1218.83.12005 Boehringer Ingelheim Investigational Site, Kitchener, Ontario, Canada|1218.83.12006 Boehringer Ingelheim Investigational Site, London, Ontario, Canada|1218.83.12003 Boehringer Ingelheim Investigational Site, Smiths Falls, Ontario, Canada|1218.83.12010 Boehringer Ingelheim Investigational Site, Sudbury, Ontario, Canada|1218.83.12012 Boehringer Ingelheim Investigational Site, Winnipeg, Ontario, Canada|1218.83.91003 Boehringer Ingelheim Investigational Site, Bangalore, India|1218.83.91005 Boehringer Ingelheim Investigational Site, Chennai, India|1218.83.91001 Boehringer Ingelheim Investigational Site, Mumbai, India|1218.83.97004 Boehringer Ingelheim Investigational Site, Haifa, Israel|1218.83.97005 Boehringer Ingelheim Investigational Site, Haifa, Israel|1218.83.97007 Boehringer Ingelheim Investigational Site, Holon, Israel|1218.83.60001 Boehringer Ingelheim Investigational Site, Kelantan, Malaysia|1218.83.60002 Boehringer Ingelheim Investigational Site, Perak, Malaysia|1218.83.60003 Boehringer Ingelheim Investigational Site, Selangor, Malaysia, Malaysia|1218.83.52004 Boehringer Ingelheim Investigational Site, Cuautla, Mexico|1218.83.52001 Boehringer Ingelheim Investigational Site, Guadalajara, Mexico|1218.83.52002 Boehringer Ingelheim Investigational Site, Guadalajara, Mexico|1218.83.52005 Boehringer Ingelheim Investigational Site, Merida, Mexico|1218.83.52003 Boehringer Ingelheim Investigational Site, Tampico, Mexico|1218.83.63007 Boehringer Ingelheim Investigational Site, Cebu City, Philippines|1218.83.63001 Boehringer Ingelheim Investigational Site, Cebu, Philippines|1218.83.63008 Boehringer Ingelheim Investigational Site, Iloilo City, Philippines|1218.83.63003 Boehringer Ingelheim Investigational Site, Iloilo, Philippines|1218.83.63002 Boehringer Ingelheim Investigational Site, Marikina City, Philippines|1218.83.63006 Boehringer Ingelheim Investigational Site, Marikina City, Philippines|1218.83.63004 Boehringer Ingelheim Investigational Site, Quezon, Philippines|1218.83.11037 Boehringer Ingelheim Investigational Site, San Juan, Puerto Rico|1218.83.07001 Boehringer Ingelheim Investigational Site, Kazan, Russian Federation|1218.83.07002 Boehringer Ingelheim Investigational Site, Petrozavodsk, Russian Federation|1218.83.07004 Boehringer Ingelheim Investigational Site, Samara, Russian Federation|1218.83.07006 Boehringer Ingelheim Investigational Site, Smolensk, Russian Federation|1218.83.07003 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1218.83.07007 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1218.83.07005 Boehringer Ingelheim Investigational Site, Yaroslavl, Russian Federation|1218.83.94004 Boehringer Ingelheim Investigational Site, Dehiwela, Sri Lanka|1218.83.94002 Boehringer Ingelheim Investigational Site, Galle, Sri Lanka, Sri Lanka|1218.83.94003 Boehringer Ingelheim Investigational Site, Kandy, Sri Lanka|1218.83.94001 Boehringer Ingelheim Investigational Site, Ragama, Sri Lanka|1218.83.66002 Boehringer Ingelheim Investigational Site, Bangkok, Thailand|1218.83.66003 Boehringer Ingelheim Investigational Site, Bangkok, Thailand|1218.83.66001 Boehringer Ingelheim Investigational Site, Muang, Khonkaen, Thailand|1218.83.38007 Boehringer Ingelheim Investigational Site, Dnepropetrovsk, Ukraine|1218.83.38001 Boehringer Ingelheim Investigational Site, Ivano-Frankivsk, Ukraine|1218.83.38006 Boehringer Ingelheim Investigational Site, Kharkiv, Ukraine|1218.83.38004 Boehringer Ingelheim Investigational Site, Odessa, Ukraine|1218.83.38008 Boehringer Ingelheim Investigational Site, Vinnitsa, Ukraine|1218.83.38003 Boehringer Ingelheim Investigational Site, Vinnytsya, Ukraine|1218.83.38005 Boehringer Ingelheim Investigational Site, Vinnytsya, Ukraine
URL: https://clinicaltrials.gov/show/NCT01512979

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details