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

January 22, 2016 updated by: Boehringer Ingelheim

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 12 Weeks in Hypertensive Patients With Type 2 Diabetes Mellitus

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

825

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • 1245.48.20002 Boehringer Ingelheim Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • 1245.48.20001 Boehringer Ingelheim Investigational Site
    • Ontario
      • Brampton, Ontario, Canada
        • 1245.48.20004 Boehringer Ingelheim Investigational Site
      • Etobicoke, Ontario, Canada
        • 1245.48.20006 Boehringer Ingelheim Investigational Site
      • Oakville, Ontario, Canada
        • 1245.48.20007 Boehringer Ingelheim Investigational Site
      • Thornhill, Ontario, Canada
        • 1245.48.20005 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1245.48.20003 Boehringer Ingelheim Investigational Site
  • Czech Republic
      • Benesov, Czech Republic
        • 1245.48.42003 Boehringer Ingelheim Investigational Site
      • Brno, Czech Republic
        • 1245.48.42005 Boehringer Ingelheim Investigational Site
      • Mlada Boleslav, Czech Republic
        • 1245.48.42002 Boehringer Ingelheim Investigational Site
      • Neratovice, Czech Republic
        • 1245.48.42006 Boehringer Ingelheim Investigational Site
      • Olomouc, Czech Republic
        • 1245.48.42008 Boehringer Ingelheim Investigational Site
      • Opocno, Czech Republic
        • 1245.48.42004 Boehringer Ingelheim Investigational Site
      • Pribram, Czech Republic
        • 1245.48.42007 Boehringer Ingelheim Investigational Site
      • Slany, Czech Republic
        • 1245.48.42001 Boehringer Ingelheim Investigational Site
  • Denmark
      • Aalborg, Denmark
        • 1245.48.45006 Boehringer Ingelheim Investigational Site
      • Aarhus C, Denmark
        • 1245.48.45009 Boehringer Ingelheim Investigational Site
      • Hellerup, Denmark
        • 1245.48.45008 Boehringer Ingelheim Investigational Site
      • Helsingør, Denmark
        • 1245.48.45002 Boehringer Ingelheim Investigational Site
      • Hillerød, Denmark
        • 1245.48.45010 Boehringer Ingelheim Investigational Site
      • København NV, Denmark
        • 1245.48.45003 Boehringer Ingelheim Investigational Site
      • Rødovre, Denmark
        • 1245.48.45001 Boehringer Ingelheim Investigational Site
      • Rødovre, Denmark
        • 1245.48.45004 Boehringer Ingelheim Investigational Site
      • Vaerløse, Denmark
        • 1245.48.45005 Boehringer Ingelheim Investigational Site
      • Vojens, Denmark
        • 1245.48.45007 Boehringer Ingelheim Investigational Site
  • Estonia
      • Pärnu, Estonia
        • 1245.48.37203 Boehringer Ingelheim Investigational Site
      • Tallinn, 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
  • Finland
      • Helsinki, Finland
        • 1245.48.35802 Boehringer Ingelheim Investigational Site
      • Joensuu, Finland
        • 1245.48.35805 Boehringer Ingelheim Investigational Site
      • Kouvola, Finland
        • 1245.48.35806 Boehringer Ingelheim Investigational Site
      • Oulu, Finland
        • 1245.48.35803 Boehringer Ingelheim Investigational Site
      • Pori, Finland
        • 1245.48.35804 Boehringer Ingelheim Investigational Site
      • Turku, Finland
        • 1245.48.35801 Boehringer Ingelheim Investigational Site
      • Turku, Finland
        • 1245.48.35807 Boehringer Ingelheim Investigational Site
  • France
      • Angers, France
        • 1245.48.33004 Boehringer Ingelheim Investigational Site
      • Bourges, France
        • 1245.48.33008 Boehringer Ingelheim Investigational Site
      • Mont de Marsan, France
        • 1245.48.33005 Boehringer Ingelheim Investigational Site
      • Nantes Cedex 1, France
        • 1245.48.33001 Boehringer Ingelheim Investigational Site
      • Orthez, France
        • 1245.48.33006 Boehringer Ingelheim Investigational Site
      • Tierce, France
        • 1245.48.33003 Boehringer Ingelheim Investigational Site
      • Tours, France
        • 1245.48.33007 Boehringer Ingelheim Investigational Site
  • Germany
      • Berlin, Germany
        • 1245.48.49001 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1245.48.49008 Boehringer Ingelheim Investigational Site
      • Dresden, Germany
        • 1245.48.49003 Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • 1245.48.49004 Boehringer Ingelheim Investigational Site
      • Lüneburg, Germany
        • 1245.48.49005 Boehringer Ingelheim Investigational Site
      • Mainz, Germany
        • 1245.48.49002 Boehringer Ingelheim Investigational Site
      • Nürnberg, Germany
        • 1245.48.49010 Boehringer Ingelheim Investigational Site
      • Pirna, Germany
        • 1245.48.49009 Boehringer Ingelheim Investigational Site
      • Schkeuditz, Germany
        • 1245.48.49007 Boehringer Ingelheim Investigational Site
      • Teuchern, Germany
        • 1245.48.49006 Boehringer Ingelheim Investigational Site
  • Lebanon
      • Baabda, Lebanon
        • 1245.48.96003 Boehringer Ingelheim Investigational Site
      • Beirut, Lebanon
        • 1245.48.96001 Boehringer Ingelheim Investigational Site
      • Lebanon, Lebanon
        • 1245.48.96002 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Breda, Netherlands
        • 1245.48.31011 Boehringer Ingelheim Investigational Site
      • Eindhoven, Netherlands
        • 1245.48.31012 Boehringer Ingelheim Investigational Site
      • Etten Leur, Netherlands
        • 1245.48.31009 Boehringer Ingelheim Investigational Site
      • Groningen, Netherlands
        • 1245.48.31014 Boehringer Ingelheim Investigational Site
      • Leiderdorp, Netherlands
        • 1245.48.31013 Boehringer Ingelheim Investigational Site
      • Oude Pekela, Netherlands
        • 1245.48.31003 Boehringer Ingelheim Investigational Site
      • Rotterdam, Netherlands
        • 1245.48.31016 Boehringer Ingelheim Investigational Site
      • Soerendonk, Netherlands
        • 1245.48.31006 Boehringer Ingelheim Investigational Site
      • Spijkenisse, Netherlands
        • 1245.48.31008 Boehringer Ingelheim Investigational Site
      • Swifterbant, Netherlands
        • 1245.48.31002 Boehringer Ingelheim Investigational Site
      • Velp, Netherlands
        • 1245.48.31015 Boehringer Ingelheim Investigational Site
      • Woerden, Netherlands
        • 1245.48.31010 Boehringer Ingelheim Investigational Site
      • Zijndrecht, Netherlands
        • 1245.48.31019 Boehringer Ingelheim Investigational Site
      • Zoetermeer, Netherlands
        • 1245.48.31017 Boehringer Ingelheim Investigational Site
  • Norway
      • Elverum, Norway
        • 1245.48.47008 Boehringer Ingelheim Investigational Site
      • Hamar, Norway
        • 1245.48.47007 Boehringer Ingelheim Investigational Site
      • Kløfta, Norway
        • 1245.48.47002 Boehringer Ingelheim Investigational Site
      • Oslo, 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
      • Sørumsand, Norway
        • 1245.48.47006 Boehringer Ingelheim Investigational Site
      • Ålesund, Norway
        • 1245.48.47009 Boehringer Ingelheim Investigational Site
  • Sweden
      • Härnösand, Sweden
        • 1245.48.46002 Boehringer Ingelheim Investigational Site
      • Järfälla, Sweden
        • 1245.48.46004 Boehringer Ingelheim Investigational Site
      • Lund, Sweden
        • 1245.48.46003 Boehringer Ingelheim Investigational Site
      • Malmö, Sweden
        • 1245.48.46007 Boehringer Ingelheim Investigational Site
      • Skene, Sweden
        • 1245.48.46006 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 1245.48.46001 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States
        • 1245.48.10024 Boehringer Ingelheim Investigational Site
    • Arizona
      • Phoenix, Arizona, United States
        • 1245.48.10002 Boehringer Ingelheim Investigational Site
    • California
      • Lincoln, California, United States
        • 1245.48.10014 Boehringer Ingelheim Investigational Site
      • Long Beach, California, United States
        • 1245.48.10030 Boehringer Ingelheim Investigational Site
      • Long Beach, California, United States
        • 1245.48.10033 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 1245.48.10027 Boehringer Ingelheim Investigational Site
      • Tustin, California, United States
        • 1245.48.10041 Boehringer Ingelheim Investigational Site
      • West Hills, California, United States
        • 1245.48.10039 Boehringer Ingelheim Investigational Site
    • Florida
      • Davie, Florida, United States
        • 1245.48.10008 Boehringer Ingelheim Investigational Site
      • Edgewater, Florida, United States
        • 1245.48.10025 Boehringer Ingelheim Investigational Site
      • Jacksonville, Florida, United States
        • 1245.48.10001 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1245.48.10016 Boehringer Ingelheim Investigational Site
      • Palm Harbor, Florida, United States
        • 1245.48.10035 Boehringer Ingelheim Investigational Site
      • Pensacola, Florida, United States
        • 1245.48.10018 Boehringer Ingelheim Investigational Site
      • Pinellas Park, Florida, United States
        • 1245.48.10032 Boehringer Ingelheim Investigational Site
    • Georgia
      • Marietta, Georgia, United States
        • 1245.48.10012 Boehringer Ingelheim Investigational Site
    • Illinois
      • Addison, Illinois, United States
        • 1245.48.10011 Boehringer Ingelheim Investigational Site
      • Arlington Heights, Illinois, United States
        • 1245.48.10019 Boehringer Ingelheim Investigational Site
      • Chicago, Illinois, United States
        • 1245.48.10022 Boehringer Ingelheim Investigational Site
    • Kansas
      • Wichita, Kansas, United States
        • 1245.48.10017 Boehringer Ingelheim Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • 1245.48.10010 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • 1245.48.10036 Boehringer Ingelheim Investigational Site
    • Ohio
      • Akron, Ohio, United States
        • 1245.48.10005 Boehringer Ingelheim Investigational Site
      • Kettering, Ohio, United States
        • 1245.48.10004 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, United States
        • 1245.48.10013 Boehringer Ingelheim Investigational Site
      • Pittsburgh, Pennsylvania, United States
        • 1245.48.10020 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States
        • 1245.48.10029 Boehringer Ingelheim Investigational Site
      • Memphis, Tennessee, United States
        • 1245.48.10015 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, United States
        • 1245.48.10034 Boehringer Ingelheim Investigational Site
      • Houston, 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
      • San Antonio, Texas, United States
        • 1245.48.10026 Boehringer Ingelheim Investigational Site
    • Utah
      • Orem, Utah, United States
        • 1245.48.10003 Boehringer Ingelheim Investigational Site
    • Washington
      • Port Orchard, Washington, United States
        • 1245.48.10023 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Patients >=18 years with type 2 diabetes
  2. HbA1c of >= 7.0% (53 mmol/mol) and =< 10% (86 mmol/mol)
  3. Mean seated systolic blood pressure 130-159 mmHg and diastolic blood pressure 80-99 mmHg

Exclusion criteria:

  1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast before randomization
  2. Known or suspected secondary hypertension
  3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BI 10773 low dose
BI 10773 low dose once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: BI 10773
BI 10773 high dose once daily
Drug: BI 10773
BI 10773 low dose once daily
Drug: Placebo
Placebo matching BI 10773 high dose
Experimental: BI 10773 high dose
BI 10773 high dose once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: BI 10773
BI 10773 high dose once daily
Drug: BI 10773
BI 10773 low dose once daily
Drug: Placebo
Placebo matching BI 10773 high dose
Placebo Comparator: Placebo
Placebo tablets matching BI 10773
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Placebo
Placebo matching BI 10773 high dose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean 24-hour Diastolic Blood Pressure Change From Baseline
Time Frame: Baseline and 12 weeks
Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks.
Baseline and 12 weeks
Proportion of Patients With HbA1c <7%
Time Frame: Baseline and 12 weeks
Proportion of patients with HbA1c <7% after 12 weeks.
Baseline and 12 weeks
Fasting Plasma Glucose (FPG) Change From Baseline
Time Frame: Baseline and 12 weeks
Change from baseline in FPG after 12 weeks of treatment.
Baseline and 12 weeks
Body Weight Change From Baseline
Time Frame: Baseline and 12 weeks
Change from baseline in body weight after 12 weeks of treatment.
Baseline and 12 weeks
Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline
Time Frame: Baseline and 12 weeks
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
Time Frame: Baseline and 12 weeks
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
Time Frame: Baseline and 12 weeks
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
Time Frame: Baseline and 12 weeks
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
Time Frame: Baseline and 12 weeks
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
Time Frame: Baseline and 12 weeks
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
Time Frame: Baseline and 12 weeks
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
Time Frame: 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%
Baseline and 12 weeks
Orthostatic Blood Pressure
Time Frame: Baseline and 12 weeks
Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment.
Baseline and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmed Hypoglycaemic Adverse Events
Time Frame: From drug administration until last drug administration plus seven days, up to 171 days
Number of participants with confirmed hypoglycaemic adverse events
From drug administration until last drug administration plus seven days, up to 171 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

June 8, 2011

First Submitted That Met QC Criteria

June 8, 2011

First Posted (Estimate)

June 9, 2011

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1245.48
  • 2011-000347-25 (EudraCT Number: EudraCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Boehringer Ingelheim Policy on Transparency and Publication http://trials.boehringer-ingelheim.com/transparency_policy.html

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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