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Clinical Trial Details

Trial ID: L1806
Source ID: NCT01194830
Associated Drug: Linagliptin
Title: Efficacy and Safety of Linagliptin (BI 1356) in Black/African Americans With Type 2 Diabetes With a MTT Sub-study
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01194830/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Linagliptin|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks, Glycosylated hemoglobin is reported as a percentage of the total hemoglobin, baseline, 24 weeks | Secondary: Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks, Glycosylated hemoglobin is reported as a percentage of the total hemoglobin, baseline, 6 weeks|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks, Glycosylated hemoglobin is reported as a percentage of the total hemoglobin, baseline, 12 weeks|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks, Glycosylated hemoglobin is reported as a percentage of the total hemoglobin, baseline, 18 weeks|Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks, Glycosylated hemoglobin is reported as a percentage of the total hemoglobin, 24 weeks|Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks, Glycosylated hemoglobin is reported as a percentage of the total hemoglobin, 24 weeks|Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks, Glycosylated hemoglobin is reported as a percentage of the total hemoglobin, 24 weeks|Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks, baseline, 24 weeks|Change From Baseline in 2-hour Post-prandial Glucose (PPG) After 24 Weeks, baseline, 24 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 234
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2010-09
Completion Date: 2011-10
Results First Posted: 2012-10-26
Last Update Posted: 2014-01-29
Locations: 1218.75.059 Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States|1218.75.054 Boehringer Ingelheim Investigational Site, Huntsville, Alabama, United States|1218.75.035 Boehringer Ingelheim Investigational Site, Mobile, Alabama, United States|1218.75.101 Boehringer Ingelheim Investigational Site, Toney, Alabama, United States|1218.75.066 Boehringer Ingelheim Investigational Site, Little Rock, Alaska, United States|1218.75.008 Boehringer Ingelheim Investigational Site, Pell City, Alaska, United States|1218.75.071 Boehringer Ingelheim Investigational Site, Anaheim, California, United States|1218.75.018 Boehringer Ingelheim Investigational Site, Chino, California, United States|1218.75.081 Boehringer Ingelheim Investigational Site, Garden Grove, California, United States|1218.75.109 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States|1218.75.040 Boehringer Ingelheim Investigational Site, Colorado Springs, Colorado, United States|1218.75.047 Boehringer Ingelheim Investigational Site, Denver, Colorado, United States|1218.75.106 Boehringer Ingelheim Investigational Site, Bartow, Florida, United States|1218.75.098 Boehringer Ingelheim Investigational Site, Bradenton, Florida, United States|1218.75.036 Boehringer Ingelheim Investigational Site, Chiefland, Florida, United States|1218.75.105 Boehringer Ingelheim Investigational Site, Fort Lauderdale, Florida, United States|1218.75.083 Boehringer Ingelheim Investigational Site, Fort Myers, Florida, United States|1218.75.002 Boehringer Ingelheim Investigational Site, Hialeah, Florida, United States|1218.75.080 Boehringer Ingelheim Investigational Site, Jacksonville, Florida, United States|1218.75.065 Boehringer Ingelheim Investigational Site, Jupiter, Florida, United States|1218.75.007 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1218.75.029 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1218.75.045 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1218.75.084 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1218.75.017 Boehringer Ingelheim Investigational Site, Ocala, Florida, United States|1218.75.012 Boehringer Ingelheim Investigational Site, Pinellas Park, Florida, United States|1218.75.074 Boehringer Ingelheim Investigational Site, Port Orange, Florida, United States|1218.75.076 Boehringer Ingelheim Investigational Site, South Miami, Florida, United States|1218.75.003 Boehringer Ingelheim Investigational Site, St. Petersburg, Florida, United States|1218.75.039 Boehringer Ingelheim Investigational Site, St. Petersburg, Florida, United States|1218.75.075 Boehringer Ingelheim Investigational Site, Tallahassee, Florida, United States|1218.75.100 Boehringer Ingelheim Investigational Site, Tamarac, Florida, United States|1218.75.015 Boehringer Ingelheim Investigational Site, Tampa, Florida, United States|1218.75.103 Boehringer Ingelheim Investigational Site, West Palm Beach, Florida, United States|1218.75.049 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States|1218.75.067 Boehringer Ingelheim Investigational Site, Calhoun, Georgia, United States|1218.75.016 Boehringer Ingelheim Investigational Site, Dunwoody, Georgia, United States|1218.75.063 Boehringer Ingelheim Investigational Site, Lawrenceville, Georgia, United States|1218.75.056 Boehringer Ingelheim Investigational Site, Marietta, Georgia, United States|1218.75.026 Boehringer Ingelheim Investigational Site, Rosswell, Georgia, United States|1218.75.079 Boehringer Ingelheim Investigational Site, Sandy Springs, Georgia, United States|1218.75.034 Boehringer Ingelheim Investigational Site, Snellville, Georgia, United States|1218.75.001 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States|1218.75.055 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States|1218.75.069 Boehringer Ingelheim Investigational Site, Owensboro, Kentucky, United States|1218.75.044 Boehringer Ingelheim Investigational Site, Baton Rouge, Louisiana, United States|1218.75.108 Boehringer Ingelheim Investigational Site, Essex, Maryland, United States|1218.75.086 Boehringer Ingelheim Investigational Site, Brockton, Massachusetts, United States|1218.75.087 Boehringer Ingelheim Investigational Site, Watertown, Massachusetts, United States|1218.75.051 Boehringer Ingelheim Investigational Site, Detroit, Michigan, United States|1218.75.088 Boehringer Ingelheim Investigational Site, Flint, Michigan, United States|1218.75.099 Boehringer Ingelheim Investigational Site, Biloxi, Mississippi, United States|1218.75.006 Boehringer Ingelheim Investigational Site, Atco, New Jersey, United States|1218.75.004 Boehringer Ingelheim Investigational Site, Camden, New Jersey, United States|1218.75.031 Boehringer Ingelheim Investigational Site, Brooklyn, New York, United States|1218.75.095 Boehringer Ingelheim Investigational Site, Brooklyn, New York, United States|1218.75.038 Boehringer Ingelheim Investigational Site, Asheboro, North Carolina, United States|1218.75.009 Boehringer Ingelheim Investigational Site, Charlotte, North Carolina, United States|1218.75.023 Boehringer Ingelheim Investigational Site, Charlotte, North Carolina, United States|1218.75.060 Boehringer Ingelheim Investigational Site, Charlotte, North Carolina, United States|1218.75.005 Boehringer Ingelheim Investigational Site, Greensboro, North Carolina, United States|1218.75.107 Boehringer Ingelheim Investigational Site, High Point, North Carolina, United States|1218.75.020 Boehringer Ingelheim Investigational Site, Jacksonville, North Carolina, United States|1218.75.027 Boehringer Ingelheim Investigational Site, Winston Salem, North Carolina, United States|1218.75.096 Boehringer Ingelheim Investigational Site, Akron, Ohio, United States|1218.75.090 Boehringer Ingelheim Investigational Site, Columbus, Ohio, United States|1218.75.078 Boehringer Ingelheim Investigational Site, Dayton, Ohio, United States|1218.75.037 Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States|1218.75.082 Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States|1218.75.010 Boehringer Ingelheim Investigational Site, Uniontown, Pennsylvania, United States|1218.75.028 Boehringer Ingelheim Investigational Site, Uniontown, Pennsylvania, United States|1218.75.091 Boehringer Ingelheim Investigational Site, Anderson, South Carolina, United States|1218.75.072 Boehringer Ingelheim Investigational Site, Columbia, South Carolina, United States|1218.75.068 Boehringer Ingelheim Investigational Site, Greenwood, South Carolina, United States|1218.75.097 Boehringer Ingelheim Investigational Site, Greer, South Carolina, United States|1218.75.024 Boehringer Ingelheim Investigational Site, Brentwood, Tennessee, United States|1218.75.025 Boehringer Ingelheim Investigational Site, Collierville, Tennessee, United States|1218.75.011 Boehringer Ingelheim Investigational Site, Germantown, Tennessee, United States|1218.75.042 Boehringer Ingelheim Investigational Site, Humboldt, Tennessee, United States|1218.75.030 Boehringer Ingelheim Investigational Site, Memphis, Tennessee, United States|1218.75.050 Boehringer Ingelheim Investigational Site, Memphis, Tennessee, United States|1218.75.053 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States|1218.75.057 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1218.75.064 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1218.75.104 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1218.75.043 Boehringer Ingelheim Investigational Site, Houton, Texas, United States|1218.75.022 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States|1218.75.058 Boehringer Ingelheim Investigational Site, Sugar Land, Texas, United States|1218.75.033 Boehringer Ingelheim Investigational Site, Tomball, Texas, United States|1218.75.102 Boehringer Ingelheim Investigational Site, Tomball, Texas, United States|1218.75.094 Boehringer Ingelheim Investigational Site, Waco, Texas, United States|1218.75.092 Boehringer Ingelheim Investigational Site, Whitney, Texas, United States|1218.75.019 Boehringer Ingelheim Investigational Site, Virgnia Beach, Virginia, United States
URL: https://clinicaltrials.gov/show/NCT01194830

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress