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Clinical Trial Details

Trial ID: L2915
Source ID: NCT00328172
Associated Drug: Placebo
Title: Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00328172/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Placebo|DRUG: BI 1356 dose 3 once daily|DRUG: BI 1356 dose 2 once daily|DRUG: BI 1356 dose 1 once daily|DRUG: Metformin
Outcome Measures: Primary: Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12, The change from baseline reflects the Week 12 HbA1c minus the Week 0 HbA1c. Means are adjusted for baseline HbA1c., Baseline, week 12 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12, Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG., Baseline, week 12|Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks, An absolute efficacy response is defined as HbA1c \<= 7.0% at 12 weeks. A non-response is defined as HbA1c \> 7.0% at 12 weeks., Baseline, week 12
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 302
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2006-05
Completion Date:
Results First Posted: 2011-06-07
Last Update Posted: 2014-03-14
Locations: 1218.5.10020 Boehringer Ingelheim Investigational Site, Chula Vista, California, United States|1218.5.10001 Boehringer Ingelheim Investigational Site, La Jolla, California, United States|1218.5.10007 Boehringer Ingelheim Investigational Site, Walnut Creek, California, United States|1218.5.10041 Boehringer Ingelheim Investigational Site, Denver, Colorado, United States|1218.5.10018 Boehringer Ingelheim Investigational Site, Hollywood, Florida, United States|1218.5.10016 Boehringer Ingelheim Investigational Site, Jacksonville, Florida, United States|1218.5.10003 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1218.5.10011 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1218.5.10012 Boehringer Ingelheim Investigational Site, Orlando, Florida, United States|1218.5.10017 Boehringer Ingelheim Investigational Site, Indianapolis, Indiana, United States|1218.5.10008 Boehringer Ingelheim Investigational Site, Topeka, Kansas, United States|1218.5.10024 Boehringer Ingelheim Investigational Site, Wichita, Kansas, United States|1218.5.10039 Boehringer Ingelheim Investigational Site, Baltimore, Maryland, United States|1218.5.10032 Boehringer Ingelheim Investigational Site, Springfield, Massachusetts, United States|1218.5.10025 Boehringer Ingelheim Investigational Site, Chesterfield, Missouri, United States|1218.5.10034 Boehringer Ingelheim Investigational Site, Butte, Montana, United States|1218.5.10009 Boehringer Ingelheim Investigational Site, Omaha, Nebraska, United States|1218.5.10042 Boehringer Ingelheim Investigational Site, Albany, New York, United States|1218.5.10029 Boehringer Ingelheim Investigational Site, Endwell, New York, United States|1218.5.10004 Boehringer Ingelheim Investigational Site, New Hyde Park, New York, United States|1218.5.10026 Boehringer Ingelheim Investigational Site, Columbus, Ohio, United States|1218.5.10035 Boehringer Ingelheim Investigational Site, Mentor, Ohio, United States|1218.5.10023 Boehringer Ingelheim Investigational Site, Medford, Oregon, United States|1218.5.10030 Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States|1218.5.10044 Boehringer Ingelheim Investigational Site, Columbia, South Carolina, United States|1218.5.10033 Boehringer Ingelheim Investigational Site, Greer, South Carolina, United States|1218.5.10038 Boehringer Ingelheim Investigational Site, Simpsonville, South Carolina, United States|1218.5.10006 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States|1218.5.10040 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1218.5.10036 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States|1218.5.10021 Boehringer Ingelheim Investigational Site, Tyler, Texas, United States|1218.5.10027 Boehringer Ingelheim Investigational Site, Salem, Virginia, United States|1218.5.10022 Boehringer Ingelheim Investigational Site, Federal Way, Washington, United States|1218.5.10014 Boehringer Ingelheim Investigational Site, Renton, Washington, United States|1218.5.61001 Boehringer Ingelheim Investigational Site, Miranda, New South Wales, Australia|1218.5.61005 Boehringer Ingelheim Investigational Site, Box Hill, Victoria, Australia|1218.5.61006 Boehringer Ingelheim Investigational Site, Dandenong, Victoria, Australia|1218.5.61007 Boehringer Ingelheim Investigational Site, East Ringwood, Victoria, Australia|1218.5.61004 Boehringer Ingelheim Investigational Site, Fremantle, Western Australia, Australia|1218.5.61002 Boehringer Ingelheim Investigational Site, Nedlands, Western Australia, Australia|1218.5.11011 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada|1218.5.11016 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada|1218.5.11003 Boehringer Ingelheim Investigational Site, Red Deer, Alberta, Canada|1218.5.11004 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada|1218.5.11013 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada|1218.5.11015 Boehringer Ingelheim Investigational Site, Winnipeg, Manitoba, Canada|1218.5.11005 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada|1218.5.11014 Boehringer Ingelheim Investigational Site, Oakville, Ontario, Canada|1218.5.11010 Boehringer Ingelheim Investigational Site, Ottawa, Ontario, Canada|1218.5.11009 Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada|1218.5.11012 Boehringer Ingelheim Investigational Site, Thornhill, Ontario, Canada|1218.5.11002 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada|1218.5.11006 Boehringer Ingelheim Investigational Site, Montague, Prince Edward Island, Canada|1218.5.11017 Boehringer Ingelheim Investigational Site, Sainte-Foy, Quebec, Canada|1218.5.11018 Boehringer Ingelheim Investigational Site, Saskatoon, Saskatchewan, Canada|1218.5.42002 Boehringer Ingelheim Investigational Site, Olomouc 9, Czech Republic|1218.5.42003 Boehringer Ingelheim Investigational Site, Praha 4, Czech Republic|1218.5.42005 Boehringer Ingelheim Investigational Site, Praha 4, Czech Republic|1218.5.42004 Boehringer Ingelheim Investigational Site, Praha 9, Czech Republic|1218.5.42001 Boehringer Ingelheim Investigational Site, Sternberk, Czech Republic|1218.5.70001 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.5.70002 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.5.70003 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1218.5.70004 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1218.5.70005 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1218.5.38005 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine|1218.5.38001 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1218.5.38002 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1218.5.38003 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1218.5.38004 Boehringer Ingelheim Investigational Site, Lvov, Ukraine|1218.5.38006 Boehringer Ingelheim Investigational Site, Vinnitsa, Ukraine
URL: https://clinicaltrials.gov/show/NCT00328172

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