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

Primary Purpose

Diabetes Mellitus, Type 2, Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
BI 10773
Placebo
BI 10773
Placebo
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1245.48.10024 Boehringer Ingelheim Investigational Site
  • 1245.48.10002 Boehringer Ingelheim Investigational Site
  • 1245.48.10014 Boehringer Ingelheim Investigational Site
  • 1245.48.10030 Boehringer Ingelheim Investigational Site
  • 1245.48.10033 Boehringer Ingelheim Investigational Site
  • 1245.48.10027 Boehringer Ingelheim Investigational Site
  • 1245.48.10041 Boehringer Ingelheim Investigational Site
  • 1245.48.10039 Boehringer Ingelheim Investigational Site
  • 1245.48.10008 Boehringer Ingelheim Investigational Site
  • 1245.48.10025 Boehringer Ingelheim Investigational Site
  • 1245.48.10001 Boehringer Ingelheim Investigational Site
  • 1245.48.10016 Boehringer Ingelheim Investigational Site
  • 1245.48.10035 Boehringer Ingelheim Investigational Site
  • 1245.48.10018 Boehringer Ingelheim Investigational Site
  • 1245.48.10032 Boehringer Ingelheim Investigational Site
  • 1245.48.10012 Boehringer Ingelheim Investigational Site
  • 1245.48.10011 Boehringer Ingelheim Investigational Site
  • 1245.48.10019 Boehringer Ingelheim Investigational Site
  • 1245.48.10022 Boehringer Ingelheim Investigational Site
  • 1245.48.10017 Boehringer Ingelheim Investigational Site
  • 1245.48.10010 Boehringer Ingelheim Investigational Site
  • 1245.48.10036 Boehringer Ingelheim Investigational Site
  • 1245.48.10005 Boehringer Ingelheim Investigational Site
  • 1245.48.10004 Boehringer Ingelheim Investigational Site
  • 1245.48.10013 Boehringer Ingelheim Investigational Site
  • 1245.48.10020 Boehringer Ingelheim Investigational Site
  • 1245.48.10029 Boehringer Ingelheim Investigational Site
  • 1245.48.10015 Boehringer Ingelheim Investigational Site
  • 1245.48.10034 Boehringer Ingelheim Investigational Site
  • 1245.48.10007 Boehringer Ingelheim Investigational Site
  • 1245.48.10009 Boehringer Ingelheim Investigational Site
  • 1245.48.10042 Boehringer Ingelheim Investigational Site
  • 1245.48.10026 Boehringer Ingelheim Investigational Site
  • 1245.48.10003 Boehringer Ingelheim Investigational Site
  • 1245.48.10023 Boehringer Ingelheim Investigational Site
  • 1245.48.20002 Boehringer Ingelheim Investigational Site
  • 1245.48.20001 Boehringer Ingelheim Investigational Site
  • 1245.48.20004 Boehringer Ingelheim Investigational Site
  • 1245.48.20006 Boehringer Ingelheim Investigational Site
  • 1245.48.20007 Boehringer Ingelheim Investigational Site
  • 1245.48.20005 Boehringer Ingelheim Investigational Site
  • 1245.48.20003 Boehringer Ingelheim Investigational Site
  • 1245.48.42003 Boehringer Ingelheim Investigational Site
  • 1245.48.42005 Boehringer Ingelheim Investigational Site
  • 1245.48.42002 Boehringer Ingelheim Investigational Site
  • 1245.48.42006 Boehringer Ingelheim Investigational Site
  • 1245.48.42008 Boehringer Ingelheim Investigational Site
  • 1245.48.42004 Boehringer Ingelheim Investigational Site
  • 1245.48.42007 Boehringer Ingelheim Investigational Site
  • 1245.48.42001 Boehringer Ingelheim Investigational Site
  • 1245.48.45006 Boehringer Ingelheim Investigational Site
  • 1245.48.45009 Boehringer Ingelheim Investigational Site
  • 1245.48.45008 Boehringer Ingelheim Investigational Site
  • 1245.48.45002 Boehringer Ingelheim Investigational Site
  • 1245.48.45010 Boehringer Ingelheim Investigational Site
  • 1245.48.45003 Boehringer Ingelheim Investigational Site
  • 1245.48.45001 Boehringer Ingelheim Investigational Site
  • 1245.48.45004 Boehringer Ingelheim Investigational Site
  • 1245.48.45005 Boehringer Ingelheim Investigational Site
  • 1245.48.45007 Boehringer Ingelheim Investigational Site
  • 1245.48.37203 Boehringer Ingelheim Investigational Site
  • 1245.48.37201 Boehringer Ingelheim Investigational Site
  • 1245.48.37202 Boehringer Ingelheim Investigational Site
  • 1245.48.37204 Boehringer Ingelheim Investigational Site
  • 1245.48.35802 Boehringer Ingelheim Investigational Site
  • 1245.48.35805 Boehringer Ingelheim Investigational Site
  • 1245.48.35806 Boehringer Ingelheim Investigational Site
  • 1245.48.35803 Boehringer Ingelheim Investigational Site
  • 1245.48.35804 Boehringer Ingelheim Investigational Site
  • 1245.48.35801 Boehringer Ingelheim Investigational Site
  • 1245.48.35807 Boehringer Ingelheim Investigational Site
  • 1245.48.33004 Boehringer Ingelheim Investigational Site
  • 1245.48.33008 Boehringer Ingelheim Investigational Site
  • 1245.48.33005 Boehringer Ingelheim Investigational Site
  • 1245.48.33001 Boehringer Ingelheim Investigational Site
  • 1245.48.33006 Boehringer Ingelheim Investigational Site
  • 1245.48.33003 Boehringer Ingelheim Investigational Site
  • 1245.48.33007 Boehringer Ingelheim Investigational Site
  • 1245.48.49001 Boehringer Ingelheim Investigational Site
  • 1245.48.49008 Boehringer Ingelheim Investigational Site
  • 1245.48.49003 Boehringer Ingelheim Investigational Site
  • 1245.48.49004 Boehringer Ingelheim Investigational Site
  • 1245.48.49005 Boehringer Ingelheim Investigational Site
  • 1245.48.49002 Boehringer Ingelheim Investigational Site
  • 1245.48.49010 Boehringer Ingelheim Investigational Site
  • 1245.48.49009 Boehringer Ingelheim Investigational Site
  • 1245.48.49007 Boehringer Ingelheim Investigational Site
  • 1245.48.49006 Boehringer Ingelheim Investigational Site
  • 1245.48.96003 Boehringer Ingelheim Investigational Site
  • 1245.48.96001 Boehringer Ingelheim Investigational Site
  • 1245.48.96002 Boehringer Ingelheim Investigational Site
  • 1245.48.31011 Boehringer Ingelheim Investigational Site
  • 1245.48.31012 Boehringer Ingelheim Investigational Site
  • 1245.48.31009 Boehringer Ingelheim Investigational Site
  • 1245.48.31014 Boehringer Ingelheim Investigational Site
  • 1245.48.31013 Boehringer Ingelheim Investigational Site
  • 1245.48.31003 Boehringer Ingelheim Investigational Site
  • 1245.48.31016 Boehringer Ingelheim Investigational Site
  • 1245.48.31006 Boehringer Ingelheim Investigational Site
  • 1245.48.31008 Boehringer Ingelheim Investigational Site
  • 1245.48.31002 Boehringer Ingelheim Investigational Site
  • 1245.48.31015 Boehringer Ingelheim Investigational Site
  • 1245.48.31010 Boehringer Ingelheim Investigational Site
  • 1245.48.31019 Boehringer Ingelheim Investigational Site
  • 1245.48.31017 Boehringer Ingelheim Investigational Site
  • 1245.48.47008 Boehringer Ingelheim Investigational Site
  • 1245.48.47007 Boehringer Ingelheim Investigational Site
  • 1245.48.47002 Boehringer Ingelheim Investigational Site
  • 1245.48.47001 Boehringer Ingelheim Investigational Site
  • 1245.48.47003 Boehringer Ingelheim Investigational Site
  • 1245.48.47004 Boehringer Ingelheim Investigational Site
  • 1245.48.47005 Boehringer Ingelheim Investigational Site
  • 1245.48.47006 Boehringer Ingelheim Investigational Site
  • 1245.48.47009 Boehringer Ingelheim Investigational Site
  • 1245.48.46002 Boehringer Ingelheim Investigational Site
  • 1245.48.46004 Boehringer Ingelheim Investigational Site
  • 1245.48.46003 Boehringer Ingelheim Investigational Site
  • 1245.48.46007 Boehringer Ingelheim Investigational Site
  • 1245.48.46006 Boehringer Ingelheim Investigational Site
  • 1245.48.46001 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

BI 10773 low dose

BI 10773 high dose

Placebo

Arm Description

BI 10773 low dose once daily

BI 10773 high dose once daily

Placebo tablets matching BI 10773

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 8, 2011
Last Updated
January 22, 2016
Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01370005
Brief Title
12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
825 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 10773 low dose
Arm Type
Experimental
Arm Description
BI 10773 low dose once daily
Arm Title
BI 10773 high dose
Arm Type
Experimental
Arm Description
BI 10773 high dose once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets matching BI 10773
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 low dose
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 high dose once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 low dose
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 low dose once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 high dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 high dose
Primary Outcome Measure Information:
Title
HbA1c Change From Baseline
Description
Change from baseline in HbA1c after 12 weeks of treatment.
Time Frame
Baseline and 12 weeks
Title
Mean 24-hour Systolic Blood Pressure Change From Baseline
Description
Change from baseline of mean 24-hour systolic blood pressure (SBP).
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Mean 24-hour Diastolic Blood Pressure Change From Baseline
Description
Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks.
Time Frame
Baseline and 12 weeks
Title
Proportion of Patients With HbA1c <7%
Description
Proportion of patients with HbA1c <7% after 12 weeks.
Time Frame
Baseline and 12 weeks
Title
Fasting Plasma Glucose (FPG) Change From Baseline
Description
Change from baseline in FPG after 12 weeks of treatment.
Time Frame
Baseline and 12 weeks
Title
Body Weight Change From Baseline
Description
Change from baseline in body weight after 12 weeks of treatment.
Time Frame
Baseline and 12 weeks
Title
Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline
Description
Change from baseline in daytime mean SBP after 12 weeks of treatment.
Time Frame
Baseline and 12 weeks
Title
Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline
Description
Change from baseline in daytime mean DBP after 12 weeks of treatment.
Time Frame
Baseline and 12 weeks
Title
Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline
Description
Change from baseline in nighttime mean SBP after 12 weeks of treatment.
Time Frame
Baseline and 12 weeks
Title
Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline
Description
Change from baseline in nighttime mean DBP after 12 weeks of treatment.
Time Frame
Baseline and 12 weeks
Title
Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline
Description
Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment.
Time Frame
Baseline and 12 weeks
Title
Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline
Description
Change from baseline in trough mean seated DBP after 12 weeks of treatment.
Time Frame
Baseline and 12 weeks
Title
Proportion of Patients Reaching Blood Pressure <130/80 mmHg
Description
Proportion of patients reaching blood pressure <130/80 mmHg after 12 weeks of treatment
Time Frame
Baseline and 12 weeks
Title
Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight
Description
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%
Time Frame
Baseline and 12 weeks
Title
Orthostatic Blood Pressure
Description
Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment.
Time Frame
Baseline and 12 weeks
Other Pre-specified Outcome Measures:
Title
Confirmed Hypoglycaemic Adverse Events
Description
Number of participants with confirmed hypoglycaemic adverse events
Time Frame
From drug administration until last drug administration plus seven days, up to 171 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients >=18 years with type 2 diabetes HbA1c of >= 7.0% (53 mmol/mol) and =< 10% (86 mmol/mol) Mean seated systolic blood pressure 130-159 mmHg and diastolic blood pressure 80-99 mmHg Exclusion criteria: Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast before randomization Known or suspected secondary hypertension Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1245.48.10024 Boehringer Ingelheim Investigational Site
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
1245.48.10002 Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
1245.48.10014 Boehringer Ingelheim Investigational Site
City
Lincoln
State/Province
California
Country
United States
Facility Name
1245.48.10030 Boehringer Ingelheim Investigational Site
City
Long Beach
State/Province
California
Country
United States
Facility Name
1245.48.10033 Boehringer Ingelheim Investigational Site
City
Long Beach
State/Province
California
Country
United States
Facility Name
1245.48.10027 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1245.48.10041 Boehringer Ingelheim Investigational Site
City
Tustin
State/Province
California
Country
United States
Facility Name
1245.48.10039 Boehringer Ingelheim Investigational Site
City
West Hills
State/Province
California
Country
United States
Facility Name
1245.48.10008 Boehringer Ingelheim Investigational Site
City
Davie
State/Province
Florida
Country
United States
Facility Name
1245.48.10025 Boehringer Ingelheim Investigational Site
City
Edgewater
State/Province
Florida
Country
United States
Facility Name
1245.48.10001 Boehringer Ingelheim Investigational Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
1245.48.10016 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
1245.48.10035 Boehringer Ingelheim Investigational Site
City
Palm Harbor
State/Province
Florida
Country
United States
Facility Name
1245.48.10018 Boehringer Ingelheim Investigational Site
City
Pensacola
State/Province
Florida
Country
United States
Facility Name
1245.48.10032 Boehringer Ingelheim Investigational Site
City
Pinellas Park
State/Province
Florida
Country
United States
Facility Name
1245.48.10012 Boehringer Ingelheim Investigational Site
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
1245.48.10011 Boehringer Ingelheim Investigational Site
City
Addison
State/Province
Illinois
Country
United States
Facility Name
1245.48.10019 Boehringer Ingelheim Investigational Site
City
Arlington Heights
State/Province
Illinois
Country
United States
Facility Name
1245.48.10022 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
1245.48.10017 Boehringer Ingelheim Investigational Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
1245.48.10010 Boehringer Ingelheim Investigational Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
1245.48.10036 Boehringer Ingelheim Investigational Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
1245.48.10005 Boehringer Ingelheim Investigational Site
City
Akron
State/Province
Ohio
Country
United States
Facility Name
1245.48.10004 Boehringer Ingelheim Investigational Site
City
Kettering
State/Province
Ohio
Country
United States
Facility Name
1245.48.10013 Boehringer Ingelheim Investigational Site
City
Erie
State/Province
Pennsylvania
Country
United States
Facility Name
1245.48.10020 Boehringer Ingelheim Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
1245.48.10029 Boehringer Ingelheim Investigational Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
1245.48.10015 Boehringer Ingelheim Investigational Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
1245.48.10034 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1245.48.10007 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1245.48.10009 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1245.48.10042 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1245.48.10026 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1245.48.10003 Boehringer Ingelheim Investigational Site
City
Orem
State/Province
Utah
Country
United States
Facility Name
1245.48.10023 Boehringer Ingelheim Investigational Site
City
Port Orchard
State/Province
Washington
Country
United States
Facility Name
1245.48.20002 Boehringer Ingelheim Investigational Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
1245.48.20001 Boehringer Ingelheim Investigational Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
1245.48.20004 Boehringer Ingelheim Investigational Site
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
1245.48.20006 Boehringer Ingelheim Investigational Site
City
Etobicoke
State/Province
Ontario
Country
Canada
Facility Name
1245.48.20007 Boehringer Ingelheim Investigational Site
City
Oakville
State/Province
Ontario
Country
Canada
Facility Name
1245.48.20005 Boehringer Ingelheim Investigational Site
City
Thornhill
State/Province
Ontario
Country
Canada
Facility Name
1245.48.20003 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1245.48.42003 Boehringer Ingelheim Investigational Site
City
Benesov
Country
Czech Republic
Facility Name
1245.48.42005 Boehringer Ingelheim Investigational Site
City
Brno
Country
Czech Republic
Facility Name
1245.48.42002 Boehringer Ingelheim Investigational Site
City
Mlada Boleslav
Country
Czech Republic
Facility Name
1245.48.42006 Boehringer Ingelheim Investigational Site
City
Neratovice
Country
Czech Republic
Facility Name
1245.48.42008 Boehringer Ingelheim Investigational Site
City
Olomouc
Country
Czech Republic
Facility Name
1245.48.42004 Boehringer Ingelheim Investigational Site
City
Opocno
Country
Czech Republic
Facility Name
1245.48.42007 Boehringer Ingelheim Investigational Site
City
Pribram
Country
Czech Republic
Facility Name
1245.48.42001 Boehringer Ingelheim Investigational Site
City
Slany
Country
Czech Republic
Facility Name
1245.48.45006 Boehringer Ingelheim Investigational Site
City
Aalborg
Country
Denmark
Facility Name
1245.48.45009 Boehringer Ingelheim Investigational Site
City
Aarhus C
Country
Denmark
Facility Name
1245.48.45008 Boehringer Ingelheim Investigational Site
City
Hellerup
Country
Denmark
Facility Name
1245.48.45002 Boehringer Ingelheim Investigational Site
City
Helsingør
Country
Denmark
Facility Name
1245.48.45010 Boehringer Ingelheim Investigational Site
City
Hillerød
Country
Denmark
Facility Name
1245.48.45003 Boehringer Ingelheim Investigational Site
City
København NV
Country
Denmark
Facility Name
1245.48.45001 Boehringer Ingelheim Investigational Site
City
Rødovre
Country
Denmark
Facility Name
1245.48.45004 Boehringer Ingelheim Investigational Site
City
Rødovre
Country
Denmark
Facility Name
1245.48.45005 Boehringer Ingelheim Investigational Site
City
Vaerløse
Country
Denmark
Facility Name
1245.48.45007 Boehringer Ingelheim Investigational Site
City
Vojens
Country
Denmark
Facility Name
1245.48.37203 Boehringer Ingelheim Investigational Site
City
Pärnu
Country
Estonia
Facility Name
1245.48.37201 Boehringer Ingelheim Investigational Site
City
Tallinn
Country
Estonia
Facility Name
1245.48.37202 Boehringer Ingelheim Investigational Site
City
Tallinn
Country
Estonia
Facility Name
1245.48.37204 Boehringer Ingelheim Investigational Site
City
Tallinn
Country
Estonia
Facility Name
1245.48.35802 Boehringer Ingelheim Investigational Site
City
Helsinki
Country
Finland
Facility Name
1245.48.35805 Boehringer Ingelheim Investigational Site
City
Joensuu
Country
Finland
Facility Name
1245.48.35806 Boehringer Ingelheim Investigational Site
City
Kouvola
Country
Finland
Facility Name
1245.48.35803 Boehringer Ingelheim Investigational Site
City
Oulu
Country
Finland
Facility Name
1245.48.35804 Boehringer Ingelheim Investigational Site
City
Pori
Country
Finland
Facility Name
1245.48.35801 Boehringer Ingelheim Investigational Site
City
Turku
Country
Finland
Facility Name
1245.48.35807 Boehringer Ingelheim Investigational Site
City
Turku
Country
Finland
Facility Name
1245.48.33004 Boehringer Ingelheim Investigational Site
City
Angers
Country
France
Facility Name
1245.48.33008 Boehringer Ingelheim Investigational Site
City
Bourges
Country
France
Facility Name
1245.48.33005 Boehringer Ingelheim Investigational Site
City
Mont de Marsan
Country
France
Facility Name
1245.48.33001 Boehringer Ingelheim Investigational Site
City
Nantes Cedex 1
Country
France
Facility Name
1245.48.33006 Boehringer Ingelheim Investigational Site
City
Orthez
Country
France
Facility Name
1245.48.33003 Boehringer Ingelheim Investigational Site
City
Tierce
Country
France
Facility Name
1245.48.33007 Boehringer Ingelheim Investigational Site
City
Tours
Country
France
Facility Name
1245.48.49001 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1245.48.49008 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1245.48.49003 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
1245.48.49004 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
1245.48.49005 Boehringer Ingelheim Investigational Site
City
Lüneburg
Country
Germany
Facility Name
1245.48.49002 Boehringer Ingelheim Investigational Site
City
Mainz
Country
Germany
Facility Name
1245.48.49010 Boehringer Ingelheim Investigational Site
City
Nürnberg
Country
Germany
Facility Name
1245.48.49009 Boehringer Ingelheim Investigational Site
City
Pirna
Country
Germany
Facility Name
1245.48.49007 Boehringer Ingelheim Investigational Site
City
Schkeuditz
Country
Germany
Facility Name
1245.48.49006 Boehringer Ingelheim Investigational Site
City
Teuchern
Country
Germany
Facility Name
1245.48.96003 Boehringer Ingelheim Investigational Site
City
Baabda
Country
Lebanon
Facility Name
1245.48.96001 Boehringer Ingelheim Investigational Site
City
Beirut
Country
Lebanon
Facility Name
1245.48.96002 Boehringer Ingelheim Investigational Site
City
Lebanon
Country
Lebanon
Facility Name
1245.48.31011 Boehringer Ingelheim Investigational Site
City
Breda
Country
Netherlands
Facility Name
1245.48.31012 Boehringer Ingelheim Investigational Site
City
Eindhoven
Country
Netherlands
Facility Name
1245.48.31009 Boehringer Ingelheim Investigational Site
City
Etten Leur
Country
Netherlands
Facility Name
1245.48.31014 Boehringer Ingelheim Investigational Site
City
Groningen
Country
Netherlands
Facility Name
1245.48.31013 Boehringer Ingelheim Investigational Site
City
Leiderdorp
Country
Netherlands
Facility Name
1245.48.31003 Boehringer Ingelheim Investigational Site
City
Oude Pekela
Country
Netherlands
Facility Name
1245.48.31016 Boehringer Ingelheim Investigational Site
City
Rotterdam
Country
Netherlands
Facility Name
1245.48.31006 Boehringer Ingelheim Investigational Site
City
Soerendonk
Country
Netherlands
Facility Name
1245.48.31008 Boehringer Ingelheim Investigational Site
City
Spijkenisse
Country
Netherlands
Facility Name
1245.48.31002 Boehringer Ingelheim Investigational Site
City
Swifterbant
Country
Netherlands
Facility Name
1245.48.31015 Boehringer Ingelheim Investigational Site
City
Velp
Country
Netherlands
Facility Name
1245.48.31010 Boehringer Ingelheim Investigational Site
City
Woerden
Country
Netherlands
Facility Name
1245.48.31019 Boehringer Ingelheim Investigational Site
City
Zijndrecht
Country
Netherlands
Facility Name
1245.48.31017 Boehringer Ingelheim Investigational Site
City
Zoetermeer
Country
Netherlands
Facility Name
1245.48.47008 Boehringer Ingelheim Investigational Site
City
Elverum
Country
Norway
Facility Name
1245.48.47007 Boehringer Ingelheim Investigational Site
City
Hamar
Country
Norway
Facility Name
1245.48.47002 Boehringer Ingelheim Investigational Site
City
Kløfta
Country
Norway
Facility Name
1245.48.47001 Boehringer Ingelheim Investigational Site
City
Oslo
Country
Norway
Facility Name
1245.48.47003 Boehringer Ingelheim Investigational Site
City
Oslo
Country
Norway
Facility Name
1245.48.47004 Boehringer Ingelheim Investigational Site
City
Oslo
Country
Norway
Facility Name
1245.48.47005 Boehringer Ingelheim Investigational Site
City
Oslo
Country
Norway
Facility Name
1245.48.47006 Boehringer Ingelheim Investigational Site
City
Sørumsand
Country
Norway
Facility Name
1245.48.47009 Boehringer Ingelheim Investigational Site
City
Ålesund
Country
Norway
Facility Name
1245.48.46002 Boehringer Ingelheim Investigational Site
City
Härnösand
Country
Sweden
Facility Name
1245.48.46004 Boehringer Ingelheim Investigational Site
City
Järfälla
Country
Sweden
Facility Name
1245.48.46003 Boehringer Ingelheim Investigational Site
City
Lund
Country
Sweden
Facility Name
1245.48.46007 Boehringer Ingelheim Investigational Site
City
Malmö
Country
Sweden
Facility Name
1245.48.46006 Boehringer Ingelheim Investigational Site
City
Skene
Country
Sweden
Facility Name
1245.48.46001 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Boehringer Ingelheim Policy on Transparency and Publication http://trials.boehringer-ingelheim.com/transparency_policy.html
Citations:
PubMed Identifier
35472672
Citation
Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
Results Reference
derived
PubMed Identifier
27977392
Citation
Mancia G, Cannon CP, Tikkanen I, Zeller C, Ley L, Woerle HJ, Broedl UC, Johansen OE. Impact of Empagliflozin on Blood Pressure in Patients With Type 2 Diabetes Mellitus and Hypertension by Background Antihypertensive Medication. Hypertension. 2016 Dec;68(6):1355-1364. doi: 10.1161/HYPERTENSIONAHA.116.07703. Epub 2016 Oct 10.
Results Reference
derived
PubMed Identifier
25271206
Citation
Tikkanen I, Narko K, Zeller C, Green A, Salsali A, Broedl UC, Woerle HJ; EMPA-REG BP Investigators. Empagliflozin reduces blood pressure in patients with type 2 diabetes and hypertension. Diabetes Care. 2015 Mar;38(3):420-8. doi: 10.2337/dc14-1096. Epub 2014 Sep 30.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1245/1245.48_U12-1526-01-DS.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1245/1245.48_Literature.pdf
Description
Related Info

Learn more about this trial

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

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