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Clinical Trial Details

Trial ID: L7023
Source ID: NCT01370005
Associated Drug: Placebo
Title: 12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01370005/results
Conditions: Diabetes Mellitus, Type 2|Hypertension
Interventions: DRUG: Placebo|DRUG: BI 10773|DRUG: Placebo|DRUG: BI 10773|DRUG: Placebo|DRUG: Placebo
Outcome Measures: Primary: HbA1c Change From Baseline, Change from baseline in HbA1c after 12 weeks of treatment., Baseline and 12 weeks|Mean 24-hour Systolic Blood Pressure Change From Baseline, Change from baseline of mean 24-hour systolic blood pressure (SBP)., Baseline and 12 weeks | Secondary: Mean 24-hour Diastolic Blood Pressure Change From Baseline, Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks., Baseline and 12 weeks|Proportion of Patients With HbA1c <7%, Proportion of patients with HbA1c \<7% after 12 weeks., Baseline and 12 weeks|Fasting Plasma Glucose (FPG) Change From Baseline, Change from baseline in FPG after 12 weeks of treatment., Baseline and 12 weeks|Body Weight Change From Baseline, Change from baseline in body weight after 12 weeks of treatment., Baseline and 12 weeks|Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline, Change from baseline in daytime mean SBP after 12 weeks of treatment., Baseline and 12 weeks|Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline, Change from baseline in daytime mean DBP after 12 weeks of treatment., Baseline and 12 weeks|Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline, Change from baseline in nighttime mean SBP after 12 weeks of treatment., Baseline and 12 weeks|Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline, Change from baseline in nighttime mean DBP after 12 weeks of treatment., Baseline and 12 weeks|Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline, Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment., Baseline and 12 weeks|Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline, Change from baseline in trough mean seated DBP after 12 weeks of treatment., Baseline and 12 weeks|Proportion of Patients Reaching Blood Pressure <130/80 mmHg, Proportion of patients reaching blood pressure \<130/80 mmHg after 12 weeks of treatment, Baseline and 12 weeks|Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight, A composite endpoint of the following conditions at week 12 compared to baseline (all 3 fulfilled): reduction of HbA1c from baseline of at least 0.5%, reduction of systolic blood pressure \> 3 mmHg from baseline and reduction of weight from baseline \> 2%, Baseline and 12 weeks|Orthostatic Blood Pressure, Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment., Baseline and 12 weeks | Other: Confirmed Hypoglycaemic Adverse Events, Number of participants with confirmed hypoglycaemic adverse events, From drug administration until last drug administration plus seven days, up to 171 days
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 825
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2011-06
Completion Date: 2012-07
Results First Posted: 2014-06-17
Last Update Posted: 2016-02-22
Locations: 1245.48.10024 Boehringer Ingelheim Investigational Site, Huntsville, Alabama, United States|1245.48.10002 Boehringer Ingelheim Investigational Site, Phoenix, Arizona, United States|1245.48.10014 Boehringer Ingelheim Investigational Site, Lincoln, California, United States|1245.48.10030 Boehringer Ingelheim Investigational Site, Long Beach, California, United States|1245.48.10033 Boehringer Ingelheim Investigational Site, Long Beach, California, United States|1245.48.10027 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States|1245.48.10041 Boehringer Ingelheim Investigational Site, Tustin, California, United States|1245.48.10039 Boehringer Ingelheim Investigational Site, West Hills, California, United States|1245.48.10008 Boehringer Ingelheim Investigational Site, Davie, Florida, United States|1245.48.10025 Boehringer Ingelheim Investigational Site, Edgewater, Florida, United States|1245.48.10001 Boehringer Ingelheim Investigational Site, Jacksonville, Florida, United States|1245.48.10016 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1245.48.10035 Boehringer Ingelheim Investigational Site, Palm Harbor, Florida, United States|1245.48.10018 Boehringer Ingelheim Investigational Site, Pensacola, Florida, United States|1245.48.10032 Boehringer Ingelheim Investigational Site, Pinellas Park, Florida, United States|1245.48.10012 Boehringer Ingelheim Investigational Site, Marietta, Georgia, United States|1245.48.10011 Boehringer Ingelheim Investigational Site, Addison, Illinois, United States|1245.48.10019 Boehringer Ingelheim Investigational Site, Arlington Heights, Illinois, United States|1245.48.10022 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States|1245.48.10017 Boehringer Ingelheim Investigational Site, Wichita, Kansas, United States|1245.48.10010 Boehringer Ingelheim Investigational Site, Albuquerque, New Mexico, United States|1245.48.10036 Boehringer Ingelheim Investigational Site, Charlotte, North Carolina, United States|1245.48.10005 Boehringer Ingelheim Investigational Site, Akron, Ohio, United States|1245.48.10004 Boehringer Ingelheim Investigational Site, Kettering, Ohio, United States|1245.48.10013 Boehringer Ingelheim Investigational Site, Erie, Pennsylvania, United States|1245.48.10020 Boehringer Ingelheim Investigational Site, Pittsburgh, Pennsylvania, United States|1245.48.10029 Boehringer Ingelheim Investigational Site, Knoxville, Tennessee, United States|1245.48.10015 Boehringer Ingelheim Investigational Site, Memphis, Tennessee, United States|1245.48.10034 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States|1245.48.10007 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1245.48.10009 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1245.48.10042 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1245.48.10026 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States|1245.48.10003 Boehringer Ingelheim Investigational Site, Orem, Utah, United States|1245.48.10023 Boehringer Ingelheim Investigational Site, Port Orchard, Washington, United States|1245.48.20002 Boehringer Ingelheim Investigational Site, Winnipeg, Manitoba, Canada|1245.48.20001 Boehringer Ingelheim Investigational Site, Halifax, Nova Scotia, Canada|1245.48.20004 Boehringer Ingelheim Investigational Site, Brampton, Ontario, Canada|1245.48.20006 Boehringer Ingelheim Investigational Site, Etobicoke, Ontario, Canada|1245.48.20007 Boehringer Ingelheim Investigational Site, Oakville, Ontario, Canada|1245.48.20005 Boehringer Ingelheim Investigational Site, Thornhill, Ontario, Canada|1245.48.20003 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada|1245.48.42003 Boehringer Ingelheim Investigational Site, Benesov, Czech Republic|1245.48.42005 Boehringer Ingelheim Investigational Site, Brno, Czech Republic|1245.48.42002 Boehringer Ingelheim Investigational Site, Mlada Boleslav, Czech Republic|1245.48.42006 Boehringer Ingelheim Investigational Site, Neratovice, Czech Republic|1245.48.42008 Boehringer Ingelheim Investigational Site, Olomouc, Czech Republic|1245.48.42004 Boehringer Ingelheim Investigational Site, Opocno, Czech Republic|1245.48.42007 Boehringer Ingelheim Investigational Site, Pribram, Czech Republic|1245.48.42001 Boehringer Ingelheim Investigational Site, Slany, Czech Republic|1245.48.45006 Boehringer Ingelheim Investigational Site, Aalborg, Denmark|1245.48.45009 Boehringer Ingelheim Investigational Site, Aarhus C, Denmark|1245.48.45008 Boehringer Ingelheim Investigational Site, Hellerup, Denmark|1245.48.45002 Boehringer Ingelheim Investigational Site, Helsingør, Denmark|1245.48.45010 Boehringer Ingelheim Investigational Site, Hillerød, Denmark|1245.48.45003 Boehringer Ingelheim Investigational Site, København NV, Denmark|1245.48.45001 Boehringer Ingelheim Investigational Site, Rødovre, Denmark|1245.48.45004 Boehringer Ingelheim Investigational Site, Rødovre, Denmark|1245.48.45005 Boehringer Ingelheim Investigational Site, Vaerløse, Denmark|1245.48.45007 Boehringer Ingelheim Investigational Site, Vojens, Denmark|1245.48.37203 Boehringer Ingelheim Investigational Site, Pärnu, Estonia|1245.48.37201 Boehringer Ingelheim Investigational Site, Tallinn, Estonia|1245.48.37202 Boehringer Ingelheim Investigational Site, Tallinn, Estonia|1245.48.37204 Boehringer Ingelheim Investigational Site, Tallinn, Estonia|1245.48.35802 Boehringer Ingelheim Investigational Site, Helsinki, Finland|1245.48.35805 Boehringer Ingelheim Investigational Site, Joensuu, Finland|1245.48.35806 Boehringer Ingelheim Investigational Site, Kouvola, Finland|1245.48.35803 Boehringer Ingelheim Investigational Site, Oulu, Finland|1245.48.35804 Boehringer Ingelheim Investigational Site, Pori, Finland|1245.48.35801 Boehringer Ingelheim Investigational Site, Turku, Finland|1245.48.35807 Boehringer Ingelheim Investigational Site, Turku, Finland|1245.48.33004 Boehringer Ingelheim Investigational Site, Angers, France|1245.48.33008 Boehringer Ingelheim Investigational Site, Bourges, France|1245.48.33005 Boehringer Ingelheim Investigational Site, Mont de Marsan, France|1245.48.33001 Boehringer Ingelheim Investigational Site, Nantes Cedex 1, France|1245.48.33006 Boehringer Ingelheim Investigational Site, Orthez, France|1245.48.33003 Boehringer Ingelheim Investigational Site, Tierce, France|1245.48.33007 Boehringer Ingelheim Investigational Site, Tours, France|1245.48.49001 Boehringer Ingelheim Investigational Site, Berlin, Germany|1245.48.49008 Boehringer Ingelheim Investigational Site, Berlin, Germany|1245.48.49003 Boehringer Ingelheim Investigational Site, Dresden, Germany|1245.48.49004 Boehringer Ingelheim Investigational Site, Hannover, Germany|1245.48.49005 Boehringer Ingelheim Investigational Site, Lüneburg, Germany|1245.48.49002 Boehringer Ingelheim Investigational Site, Mainz, Germany|1245.48.49010 Boehringer Ingelheim Investigational Site, Nürnberg, Germany|1245.48.49009 Boehringer Ingelheim Investigational Site, Pirna, Germany|1245.48.49007 Boehringer Ingelheim Investigational Site, Schkeuditz, Germany|1245.48.49006 Boehringer Ingelheim Investigational Site, Teuchern, Germany|1245.48.96003 Boehringer Ingelheim Investigational Site, Baabda, Lebanon|1245.48.96001 Boehringer Ingelheim Investigational Site, Beirut, Lebanon|1245.48.96002 Boehringer Ingelheim Investigational Site, Lebanon, Lebanon|1245.48.31011 Boehringer Ingelheim Investigational Site, Breda, Netherlands|1245.48.31012 Boehringer Ingelheim Investigational Site, Eindhoven, Netherlands|1245.48.31009 Boehringer Ingelheim Investigational Site, Etten Leur, Netherlands|1245.48.31014 Boehringer Ingelheim Investigational Site, Groningen, Netherlands|1245.48.31013 Boehringer Ingelheim Investigational Site, Leiderdorp, Netherlands|1245.48.31003 Boehringer Ingelheim Investigational Site, Oude Pekela, Netherlands|1245.48.31016 Boehringer Ingelheim Investigational Site, Rotterdam, Netherlands|1245.48.31006 Boehringer Ingelheim Investigational Site, Soerendonk, Netherlands|1245.48.31008 Boehringer Ingelheim Investigational Site, Spijkenisse, Netherlands|1245.48.31002 Boehringer Ingelheim Investigational Site, Swifterbant, Netherlands|1245.48.31015 Boehringer Ingelheim Investigational Site, Velp, Netherlands|1245.48.31010 Boehringer Ingelheim Investigational Site, Woerden, Netherlands|1245.48.31019 Boehringer Ingelheim Investigational Site, Zijndrecht, Netherlands|1245.48.31017 Boehringer Ingelheim Investigational Site, Zoetermeer, Netherlands|1245.48.47008 Boehringer Ingelheim Investigational Site, Elverum, Norway|1245.48.47007 Boehringer Ingelheim Investigational Site, Hamar, Norway|1245.48.47002 Boehringer Ingelheim Investigational Site, Kløfta, Norway|1245.48.47001 Boehringer Ingelheim Investigational Site, Oslo, Norway|1245.48.47003 Boehringer Ingelheim Investigational Site, Oslo, Norway|1245.48.47004 Boehringer Ingelheim Investigational Site, Oslo, Norway|1245.48.47005 Boehringer Ingelheim Investigational Site, Oslo, Norway|1245.48.47006 Boehringer Ingelheim Investigational Site, Sørumsand, Norway|1245.48.47009 Boehringer Ingelheim Investigational Site, Ålesund, Norway|1245.48.46002 Boehringer Ingelheim Investigational Site, Härnösand, Sweden|1245.48.46004 Boehringer Ingelheim Investigational Site, Järfälla, Sweden|1245.48.46003 Boehringer Ingelheim Investigational Site, Lund, Sweden|1245.48.46007 Boehringer Ingelheim Investigational Site, Malmö, Sweden|1245.48.46006 Boehringer Ingelheim Investigational Site, Skene, Sweden|1245.48.46001 Boehringer Ingelheim Investigational Site, Stockholm, Sweden
URL: https://clinicaltrials.gov/show/NCT01370005

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress