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Clinical Trial Details

Trial ID: L4098
Source ID: NCT00996658
Associated Drug: Placebo
Title: Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00996658/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Placebo|DRUG: Linagliptin
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, Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24, baseline, 24 weeks|Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks, Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6, baseline, 6 weeks|Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks, Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12, baseline, 12 weeks|Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks, Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18, baseline, 18 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 278
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2009-10
Completion Date:
Results First Posted: 2013-03-26
Last Update Posted: 2014-03-26
Locations: 1218.61.01028 Boehringer Ingelheim Investigational Site, Escondido, California, United States|1218.61.01014 Boehringer Ingelheim Investigational Site, Greenbrae, California, United States|1218.61.01015 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States|1218.61.01042 Boehringer Ingelheim Investigational Site, Paramount, California, United States|1218.61.01046 Boehringer Ingelheim Investigational Site, Poway, California, United States|1218.61.01044 Boehringer Ingelheim Investigational Site, San Diego, California, United States|1218.61.01009 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1218.61.01049 Boehringer Ingelheim Investigational Site, Lawrenceville, Georgia, United States|1218.61.01008 Boehringer Ingelheim Investigational Site, Roswell, Georgia, United States|1218.61.01040 Boehringer Ingelheim Investigational Site, Meridian, Idaho, United States|1218.61.01016 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States|1218.61.01018 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States|1218.61.01048 Boehringer Ingelheim Investigational Site, Lafayette, Indiana, United States|1218.61.01001 Boehringer Ingelheim Investigational Site, Auburn, Maine, United States|1218.61.01043 Boehringer Ingelheim Investigational Site, Olive Branch, Mississippi, United States|1218.61.01052 Boehringer Ingelheim Investigational Site, Las Vegas, Nevada, United States|1218.61.01030 Boehringer Ingelheim Investigational Site, New York, New York, United States|1218.61.01007 Boehringer Ingelheim Investigational Site, Greensboro, North Carolina, United States|1218.61.01004 Boehringer Ingelheim Investigational Site, Jacksonville, North Carolina, United States|1218.61.01023 Boehringer Ingelheim Investigational Site, Wilmington, North Carolina, United States|1218.61.01027 Boehringer Ingelheim Investigational Site, Perrysburg, Ohio, United States|1218.61.01031 Boehringer Ingelheim Investigational Site, East Providence, Rhode Island, United States|1218.61.01017 Boehringer Ingelheim Investigational Site, Simpsonville, South Carolina, United States|1218.61.01005 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States|1218.61.01006 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1218.61.01053 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States|1218.61.01003 Boehringer Ingelheim Investigational Site, Sugar Land, Texas, United States|1218.61.01024 Boehringer Ingelheim Investigational Site, Bennington, Vermont, United States|1218.61.01020 Boehringer Ingelheim Investigational Site, Spokane, Washington, United States|1218.61.3301A Boehringer Ingelheim Investigational Site, Besancon, France|1218.61.3306A Boehringer Ingelheim Investigational Site, Beziers, France|1218.61.3311A Boehringer Ingelheim Investigational Site, Beziers, France|1218.61.3309A Boehringer Ingelheim Investigational Site, Bourg des cptes, France|1218.61.3310A Boehringer Ingelheim Investigational Site, Cournonterral, France|1218.61.3312A Boehringer Ingelheim Investigational Site, Laval, France|1218.61.3313A Boehringer Ingelheim Investigational Site, Louvigne De bais, France|1218.61.3305A Boehringer Ingelheim Investigational Site, Paris, France|1218.61.3307A Boehringer Ingelheim Investigational Site, Paris, France|1218.61.91002 Boehringer Ingelheim Investigational Site, Bangalore, India|1218.61.91003 Boehringer Ingelheim Investigational Site, Bangalore, India|1218.61.91004 Boehringer Ingelheim Investigational Site, Bangalore, India|1218.61.91008 Boehringer Ingelheim Investigational Site, Hyderabad, India|1218.61.91009 Boehringer Ingelheim Investigational Site, Jaipur, India|1218.61.91010 Boehringer Ingelheim Investigational Site, Karnataka, India|1218.61.91001 Boehringer Ingelheim Investigational Site, Maharashtra, India|1218.61.91006 Boehringer Ingelheim Investigational Site, Maharashtra, India|1218.61.91011 Boehringer Ingelheim Investigational Site, Maharashtra, India|1218.61.91005 Boehringer Ingelheim Investigational Site, Mumbai, India|1218.61.91007 Boehringer Ingelheim Investigational Site, Mumbai, India|1218.61.63003 Boehringer Ingelheim Investigational Site, Cebu City, Philippines|1218.61.63004 Boehringer Ingelheim Investigational Site, Cebu City, Philippines|1218.61.63002 Boehringer Ingelheim Investigational Site, Davao City, Philippines
URL: https://clinicaltrials.gov/show/NCT00996658

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress