12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2; Hypertension
• Interventions: Drug: Placebo; Drug: BI 10773

• Registration Number: NCT01370005
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-08
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-09
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2014-05-16
• Results First Submitted QC: 2014-05-16
• Results First Posted: 2014-06-17
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-22
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 825

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablets matching BI 10773
BI 10773 low dose	Placebo	BI 10773 low dose once daily
BI 10773 low dose	BI 10773	BI 10773 low dose once daily
BI 10773 high dose	BI 10773	BI 10773 high dose once daily
BI 10773 high dose	Placebo	BI 10773 high dose once daily

Primary Outcome Measures

Name	Time	Method
HbA1c Change From Baseline	Baseline and 12 weeks	Change from baseline in HbA1c after 12 weeks of treatment.
Mean 24-hour Systolic Blood Pressure Change From Baseline	Baseline and 12 weeks	Change from baseline of mean 24-hour systolic blood pressure (SBP).

Secondary Outcome Measures

Name	Time	Method
Mean 24-hour Diastolic Blood Pressure Change From Baseline	Baseline and 12 weeks	Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks.
Proportion of Patients With HbA1c <7%	Baseline and 12 weeks	Proportion of patients with HbA1c \<7% after 12 weeks.
Fasting Plasma Glucose (FPG) Change From Baseline	Baseline and 12 weeks	Change from baseline in FPG after 12 weeks of treatment.
Body Weight Change From Baseline	Baseline and 12 weeks	Change from baseline in body weight after 12 weeks of treatment.
Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline	Baseline and 12 weeks	Change from baseline in daytime mean SBP after 12 weeks of treatment.
Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline	Baseline and 12 weeks	Change from baseline in daytime mean DBP after 12 weeks of treatment.
Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline	Baseline and 12 weeks	Change from baseline in nighttime mean SBP after 12 weeks of treatment.
Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline	Baseline and 12 weeks	Change from baseline in nighttime mean DBP after 12 weeks of treatment.
Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline	Baseline and 12 weeks	Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment.
Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline	Baseline and 12 weeks	Change from baseline in trough mean seated DBP after 12 weeks of treatment.
Proportion of Patients Reaching Blood Pressure <130/80 mmHg	Baseline and 12 weeks	Proportion of patients reaching blood pressure \<130/80 mmHg after 12 weeks of treatment
Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight	Baseline and 12 weeks	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%
Orthostatic Blood Pressure	Baseline and 12 weeks	Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment.

Trial Locations

Locations (120)

1245.48.10012 Boehringer Ingelheim Investigational Site; 🇺🇸 Marietta, Georgia, United States

1245.48.31017 Boehringer Ingelheim Investigational Site; 🇳🇱 Zoetermeer, Netherlands

1245.48.10027 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

1245.48.10016 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

1245.48.10020 Boehringer Ingelheim Investigational Site; 🇺🇸 Pittsburgh, Pennsylvania, United States

1245.48.10008 Boehringer Ingelheim Investigational Site; 🇺🇸 Davie, Florida, United States

1245.48.42003 Boehringer Ingelheim Investigational Site; 🇨🇿 Benesov, Czech Republic

1245.48.10002 Boehringer Ingelheim Investigational Site; 🇺🇸 Phoenix, Arizona, United States

1245.48.10030 Boehringer Ingelheim Investigational Site; 🇺🇸 Long Beach, California, United States

1245.48.10034 Boehringer Ingelheim Investigational Site; 🇺🇸 Dallas, Texas, United States

1245.48.10010 Boehringer Ingelheim Investigational Site; 🇺🇸 Albuquerque, New Mexico, United States

1245.48.10014 Boehringer Ingelheim Investigational Site; 🇺🇸 Lincoln, California, United States

1245.48.10032 Boehringer Ingelheim Investigational Site; 🇺🇸 Pinellas Park, Florida, United States

1245.48.10004 Boehringer Ingelheim Investigational Site; 🇺🇸 Kettering, Ohio, United States

1245.48.10013 Boehringer Ingelheim Investigational Site; 🇺🇸 Erie, Pennsylvania, United States

1245.48.10033 Boehringer Ingelheim Investigational Site; 🇺🇸 Long Beach, California, United States

1245.48.31012 Boehringer Ingelheim Investigational Site; 🇳🇱 Eindhoven, Netherlands

1245.48.31009 Boehringer Ingelheim Investigational Site; 🇳🇱 Etten Leur, Netherlands

1245.48.20005 Boehringer Ingelheim Investigational Site; 🇨🇦 Thornhill, Ontario, Canada

1245.48.33004 Boehringer Ingelheim Investigational Site; 🇫🇷 Angers, France

1245.48.20002 Boehringer Ingelheim Investigational Site; 🇨🇦 Winnipeg, Manitoba, Canada

1245.48.20001 Boehringer Ingelheim Investigational Site; 🇨🇦 Halifax, Nova Scotia, Canada

1245.48.10024 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntsville, Alabama, United States

1245.48.31013 Boehringer Ingelheim Investigational Site; 🇳🇱 Leiderdorp, Netherlands

1245.48.10026 Boehringer Ingelheim Investigational Site; 🇺🇸 San Antonio, Texas, United States

1245.48.42008 Boehringer Ingelheim Investigational Site; 🇨🇿 Olomouc, Czech Republic

1245.48.31002 Boehringer Ingelheim Investigational Site; 🇳🇱 Swifterbant, Netherlands

1245.48.31015 Boehringer Ingelheim Investigational Site; 🇳🇱 Velp, Netherlands

1245.48.20004 Boehringer Ingelheim Investigational Site; 🇨🇦 Brampton, Ontario, Canada

1245.48.31003 Boehringer Ingelheim Investigational Site; 🇳🇱 Oude Pekela, Netherlands

1245.48.46007 Boehringer Ingelheim Investigational Site; 🇸🇪 Malmö, Sweden

1245.48.42007 Boehringer Ingelheim Investigational Site; 🇨🇿 Pribram, Czech Republic

1245.48.31014 Boehringer Ingelheim Investigational Site; 🇳🇱 Groningen, Netherlands

1245.48.31016 Boehringer Ingelheim Investigational Site; 🇳🇱 Rotterdam, Netherlands

1245.48.31006 Boehringer Ingelheim Investigational Site; 🇳🇱 Soerendonk, Netherlands

1245.48.42006 Boehringer Ingelheim Investigational Site; 🇨🇿 Neratovice, Czech Republic

1245.48.42004 Boehringer Ingelheim Investigational Site; 🇨🇿 Opocno, Czech Republic

1245.48.47008 Boehringer Ingelheim Investigational Site; 🇳🇴 Elverum, Norway

1245.48.46003 Boehringer Ingelheim Investigational Site; 🇸🇪 Lund, Sweden

1245.48.20003 Boehringer Ingelheim Investigational Site; 🇨🇦 Toronto, Ontario, Canada

1245.48.31010 Boehringer Ingelheim Investigational Site; 🇳🇱 Woerden, Netherlands

1245.48.31019 Boehringer Ingelheim Investigational Site; 🇳🇱 Zijndrecht, Netherlands

1245.48.37204 Boehringer Ingelheim Investigational Site; 🇪🇪 Tallinn, Estonia

1245.48.49003 Boehringer Ingelheim Investigational Site; 🇩🇪 Dresden, Germany

1245.48.33008 Boehringer Ingelheim Investigational Site; 🇫🇷 Bourges, France

1245.48.46002 Boehringer Ingelheim Investigational Site; 🇸🇪 Härnösand, Sweden

1245.48.45006 Boehringer Ingelheim Investigational Site; 🇩🇰 Aalborg, Denmark

1245.48.45010 Boehringer Ingelheim Investigational Site; 🇩🇰 Hillerød, Denmark

1245.48.45009 Boehringer Ingelheim Investigational Site; 🇩🇰 Aarhus C, Denmark

1245.48.45008 Boehringer Ingelheim Investigational Site; 🇩🇰 Hellerup, Denmark

1245.48.45003 Boehringer Ingelheim Investigational Site; 🇩🇰 København NV, Denmark

1245.48.45004 Boehringer Ingelheim Investigational Site; 🇩🇰 Rødovre, Denmark

1245.48.45007 Boehringer Ingelheim Investigational Site; 🇩🇰 Vojens, Denmark

1245.48.45002 Boehringer Ingelheim Investigational Site; 🇩🇰 Helsingør, Denmark

1245.48.45001 Boehringer Ingelheim Investigational Site; 🇩🇰 Rødovre, Denmark

1245.48.42002 Boehringer Ingelheim Investigational Site; 🇨🇿 Mlada Boleslav, Czech Republic

1245.48.35806 Boehringer Ingelheim Investigational Site; 🇫🇮 Kouvola, Finland

1245.48.47002 Boehringer Ingelheim Investigational Site; 🇳🇴 Kløfta, Norway

1245.48.42005 Boehringer Ingelheim Investigational Site; 🇨🇿 Brno, Czech Republic

1245.48.35805 Boehringer Ingelheim Investigational Site; 🇫🇮 Joensuu, Finland

1245.48.47001 Boehringer Ingelheim Investigational Site; 🇳🇴 Oslo, Norway

1245.48.47006 Boehringer Ingelheim Investigational Site; 🇳🇴 Sørumsand, Norway

1245.48.10003 Boehringer Ingelheim Investigational Site; 🇺🇸 Orem, Utah, United States

1245.48.10015 Boehringer Ingelheim Investigational Site; 🇺🇸 Memphis, Tennessee, United States

1245.48.10009 Boehringer Ingelheim Investigational Site; 🇺🇸 Houston, Texas, United States

1245.48.10007 Boehringer Ingelheim Investigational Site; 🇺🇸 Houston, Texas, United States

1245.48.10029 Boehringer Ingelheim Investigational Site; 🇺🇸 Knoxville, Tennessee, United States

1245.48.10042 Boehringer Ingelheim Investigational Site; 🇺🇸 Houston, Texas, United States

1245.48.20006 Boehringer Ingelheim Investigational Site; 🇨🇦 Etobicoke, Ontario, Canada

1245.48.20007 Boehringer Ingelheim Investigational Site; 🇨🇦 Oakville, Ontario, Canada

1245.48.10041 Boehringer Ingelheim Investigational Site; 🇺🇸 Tustin, California, United States

1245.48.10039 Boehringer Ingelheim Investigational Site; 🇺🇸 West Hills, California, United States

1245.48.10025 Boehringer Ingelheim Investigational Site; 🇺🇸 Edgewater, Florida, United States

1245.48.10001 Boehringer Ingelheim Investigational Site; 🇺🇸 Jacksonville, 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

1245.48.10019 Boehringer Ingelheim Investigational Site; 🇺🇸 Arlington Heights, Illinois, United States

1245.48.10011 Boehringer Ingelheim Investigational Site; 🇺🇸 Addison, 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

1245.48.10036 Boehringer Ingelheim Investigational Site; 🇺🇸 Charlotte, North Carolina, United States

1245.48.10005 Boehringer Ingelheim Investigational Site; 🇺🇸 Akron, Ohio, United States

1245.48.10023 Boehringer Ingelheim Investigational Site; 🇺🇸 Port Orchard, Washington, United States

1245.48.45005 Boehringer Ingelheim Investigational Site; 🇩🇰 Vaerløse, 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

1245.48.35802 Boehringer Ingelheim Investigational Site; 🇫🇮 Helsinki, Finland

1245.48.35801 Boehringer Ingelheim Investigational Site; 🇫🇮 Turku, Finland

1245.48.33001 Boehringer Ingelheim Investigational Site; 🇫🇷 Nantes Cedex 1, France

1245.48.33005 Boehringer Ingelheim Investigational Site; 🇫🇷 Mont de Marsan, 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

1245.48.49005 Boehringer Ingelheim Investigational Site; 🇩🇪 Lüneburg, Germany

1245.48.49004 Boehringer Ingelheim Investigational Site; 🇩🇪 Hannover, Germany

1245.48.49002 Boehringer Ingelheim Investigational Site; 🇩🇪 Mainz, Germany

1245.48.49007 Boehringer Ingelheim Investigational Site; 🇩🇪 Schkeuditz, Germany

1245.48.49009 Boehringer Ingelheim Investigational Site; 🇩🇪 Pirna, Germany

1245.48.49006 Boehringer Ingelheim Investigational Site; 🇩🇪 Teuchern, Germany

1245.48.49010 Boehringer Ingelheim Investigational Site; 🇩🇪 Nürnberg, Germany

1245.48.96003 Boehringer Ingelheim Investigational Site; 🇱🇧 Baabda, Lebanon

1245.48.96001 Boehringer Ingelheim Investigational Site; 🇱🇧 Beirut, Lebanon

1245.48.31011 Boehringer Ingelheim Investigational Site; 🇳🇱 Breda, Netherlands

1245.48.96002 Boehringer Ingelheim Investigational Site; 🇱🇧 Lebanon, Lebanon

1245.48.31008 Boehringer Ingelheim Investigational Site; 🇳🇱 Spijkenisse, Netherlands

1245.48.46004 Boehringer Ingelheim Investigational Site; 🇸🇪 Järfälla, Sweden

1245.48.46006 Boehringer Ingelheim Investigational Site; 🇸🇪 Skene, Sweden

1245.48.46001 Boehringer Ingelheim Investigational Site; 🇸🇪 Stockholm, Sweden

1245.48.35803 Boehringer Ingelheim Investigational Site; 🇫🇮 Oulu, Finland

1245.48.35804 Boehringer Ingelheim Investigational Site; 🇫🇮 Pori, Finland

1245.48.47007 Boehringer Ingelheim Investigational Site; 🇳🇴 Hamar, Norway

1245.48.47004 Boehringer Ingelheim Investigational Site; 🇳🇴 Oslo, Norway

1245.48.47009 Boehringer Ingelheim Investigational Site; 🇳🇴 Ålesund, Norway

1245.48.35807 Boehringer Ingelheim Investigational Site; 🇫🇮 Turku, Finland

1245.48.42001 Boehringer Ingelheim Investigational Site; 🇨🇿 Slany, Czech Republic

1245.48.47003 Boehringer Ingelheim Investigational Site; 🇳🇴 Oslo, Norway

1245.48.47005 Boehringer Ingelheim Investigational Site; 🇳🇴 Oslo, Norway