Clinical trial NCT01370005: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2011-06-09
Enrollment: 825
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: HbA1c Change From Baseline
timeFrame: Baseline and 12 weeks
measure: Mean 24-hour Systolic Blood Pressure Change From Baseline
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Mean 24-hour Diastolic Blood Pressure Change From Baseline
timeFrame: Baseline and 12 weeks
measure: Proportion of Patients With HbA1c <7%
timeFrame: Baseline and 12 weeks
measure: Fasting Plasma Glucose (FPG) Change From Baseline
timeFrame: Baseline and 12 weeks
measure: Body Weight Change From Baseline
timeFrame: Baseline and 12 weeks
measure: Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline
timeFrame: Baseline and 12 weeks
measure: Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline
timeFrame: Baseline and 12 weeks
measure: Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline
timeFrame: Baseline and 12 weeks
measure: Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline
timeFrame: Baseline and 12 weeks
measure: Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline
timeFrame: Baseline and 12 weeks
measure: Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline
timeFrame: Baseline and 12 weeks
measure: Proportion of Patients Reaching Blood Pressure <130/80 mmHg
timeFrame: Baseline and 12 weeks
measure: Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight
timeFrame: Baseline and 12 weeks
measure: Orthostatic Blood Pressure
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Confirmed Hypoglycaemic Adverse Events
timeFrame: From drug administration until last drug administration plus seven days, up to 171 days
Locations:
city: Huntsville
country: United States
facility: 1245.48.10024 Boehringer Ingelheim Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: 1245.48.10002 Boehringer Ingelheim Investigational Site
state: Arizona
city: Lincoln
country: United States
facility: 1245.48.10014 Boehringer Ingelheim Investigational Site
state: California
city: Long Beach
country: United States
facility: 1245.48.10030 Boehringer Ingelheim Investigational Site
state: California
city: Long Beach
country: United States
facility: 1245.48.10033 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1245.48.10027 Boehringer Ingelheim Investigational Site
state: California
city: Tustin
country: United States
facility: 1245.48.10041 Boehringer Ingelheim Investigational Site
state: California
city: West Hills
country: United States
facility: 1245.48.10039 Boehringer Ingelheim Investigational Site
state: California
city: Davie
country: United States
facility: 1245.48.10008 Boehringer Ingelheim Investigational Site
state: Florida
city: Edgewater
country: United States
facility: 1245.48.10025 Boehringer Ingelheim Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: 1245.48.10001 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1245.48.10016 Boehringer Ingelheim Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: 1245.48.10035 Boehringer Ingelheim Investigational Site
state: Florida
city: Pensacola
country: United States
facility: 1245.48.10018 Boehringer Ingelheim Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: 1245.48.10032 Boehringer Ingelheim Investigational Site
state: Florida
city: Marietta
country: United States
facility: 1245.48.10012 Boehringer Ingelheim Investigational Site
state: Georgia
city: Addison
country: United States
facility: 1245.48.10011 Boehringer Ingelheim Investigational Site
state: Illinois
city: Arlington Heights
country: United States
facility: 1245.48.10019 Boehringer Ingelheim Investigational Site
state: Illinois
city: Chicago
country: United States
facility: 1245.48.10022 Boehringer Ingelheim Investigational Site
state: Illinois
city: Wichita
country: United States
facility: 1245.48.10017 Boehringer Ingelheim Investigational Site
state: Kansas
city: Albuquerque
country: United States
facility: 1245.48.10010 Boehringer Ingelheim Investigational Site
state: New Mexico
city: Charlotte
country: United States
facility: 1245.48.10036 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Akron
country: United States
facility: 1245.48.10005 Boehringer Ingelheim Investigational Site
state: Ohio
city: Kettering
country: United States
facility: 1245.48.10004 Boehringer Ingelheim Investigational Site
state: Ohio
city: Erie
country: United States
facility: 1245.48.10013 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 1245.48.10020 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Knoxville
country: United States
facility: 1245.48.10029 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: 1245.48.10015 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: 1245.48.10034 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1245.48.10007 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1245.48.10009 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1245.48.10042 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1245.48.10026 Boehringer Ingelheim Investigational Site
state: Texas
city: Orem
country: United States
facility: 1245.48.10003 Boehringer Ingelheim Investigational Site
state: Utah
city: Port Orchard
country: United States
facility: 1245.48.10023 Boehringer Ingelheim Investigational Site
state: Washington
city: Winnipeg
country: Canada
facility: 1245.48.20002 Boehringer Ingelheim Investigational Site
state: Manitoba
city: Halifax
country: Canada
facility: 1245.48.20001 Boehringer Ingelheim Investigational Site
state: Nova Scotia
city: Brampton
country: Canada
facility: 1245.48.20004 Boehringer Ingelheim Investigational Site
state: Ontario
city: Etobicoke
country: Canada
facility: 1245.48.20006 Boehringer Ingelheim Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: 1245.48.20007 Boehringer Ingelheim Investigational Site
state: Ontario
city: Thornhill
country: Canada
facility: 1245.48.20005 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1245.48.20003 Boehringer Ingelheim Investigational Site
state: Ontario
city: Benesov
country: Czech Republic
facility: 1245.48.42003 Boehringer Ingelheim Investigational Site
city: Brno
country: Czech Republic
facility: 1245.48.42005 Boehringer Ingelheim Investigational Site
city: Mlada Boleslav
country: Czech Republic
facility: 1245.48.42002 Boehringer Ingelheim Investigational Site
city: Neratovice
country: Czech Republic
facility: 1245.48.42006 Boehringer Ingelheim Investigational Site
city: Olomouc
country: Czech Republic
facility: 1245.48.42008 Boehringer Ingelheim Investigational Site
city: Opocno
country: Czech Republic
facility: 1245.48.42004 Boehringer Ingelheim Investigational Site
city: Pribram
country: Czech Republic
facility: 1245.48.42007 Boehringer Ingelheim Investigational Site
city: Slany
country: Czech Republic
facility: 1245.48.42001 Boehringer Ingelheim Investigational Site
city: Aalborg
country: Denmark
facility: 1245.48.45006 Boehringer Ingelheim Investigational Site
city: Aarhus C
country: Denmark
facility: 1245.48.45009 Boehringer Ingelheim Investigational Site
city: Hellerup
country: Denmark
facility: 1245.48.45008 Boehringer Ingelheim Investigational Site
city: Helsingør
country: Denmark
facility: 1245.48.45002 Boehringer Ingelheim Investigational Site
city: Hillerød
country: Denmark
facility: 1245.48.45010 Boehringer Ingelheim Investigational Site
city: København NV
country: Denmark
facility: 1245.48.45003 Boehringer Ingelheim Investigational Site
city: Rødovre
country: Denmark
facility: 1245.48.45001 Boehringer Ingelheim Investigational Site
city: Rødovre
country: Denmark
facility: 1245.48.45004 Boehringer Ingelheim Investigational Site
city: Vaerløse
country: Denmark
facility: 1245.48.45005 Boehringer Ingelheim Investigational Site
city: Vojens
country: Denmark
facility: 1245.48.45007 Boehringer Ingelheim Investigational Site
city: Pärnu
country: Estonia
facility: 1245.48.37203 Boehringer Ingelheim Investigational Site
city: Tallinn
country: Estonia
facility: 1245.48.37201 Boehringer Ingelheim Investigational Site
city: Tallinn
country: Estonia
facility: 1245.48.37202 Boehringer Ingelheim Investigational Site
city: Tallinn
country: Estonia
facility: 1245.48.37204 Boehringer Ingelheim Investigational Site
city: Helsinki
country: Finland
facility: 1245.48.35802 Boehringer Ingelheim Investigational Site
city: Joensuu
country: Finland
facility: 1245.48.35805 Boehringer Ingelheim Investigational Site
city: Kouvola
country: Finland
facility: 1245.48.35806 Boehringer Ingelheim Investigational Site
city: Oulu
country: Finland
facility: 1245.48.35803 Boehringer Ingelheim Investigational Site
city: Pori
country: Finland
facility: 1245.48.35804 Boehringer Ingelheim Investigational Site
city: Turku
country: Finland
facility: 1245.48.35801 Boehringer Ingelheim Investigational Site
city: Turku
country: Finland
facility: 1245.48.35807 Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: 1245.48.33004 Boehringer Ingelheim Investigational Site
city: Bourges
country: France
facility: 1245.48.33008 Boehringer Ingelheim Investigational Site
city: Mont de Marsan
country: France
facility: 1245.48.33005 Boehringer Ingelheim Investigational Site
city: Nantes Cedex 1
country: France
facility: 1245.48.33001 Boehringer Ingelheim Investigational Site
city: Orthez
country: France
facility: 1245.48.33006 Boehringer Ingelheim Investigational Site
city: Tierce
country: France
facility: 1245.48.33003 Boehringer Ingelheim Investigational Site
city: Tours
country: France
facility: 1245.48.33007 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1245.48.49001 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1245.48.49008 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 1245.48.49003 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1245.48.49004 Boehringer Ingelheim Investigational Site
city: Lüneburg
country: Germany
facility: 1245.48.49005 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1245.48.49002 Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: 1245.48.49010 Boehringer Ingelheim Investigational Site
city: Pirna
country: Germany
facility: 1245.48.49009 Boehringer Ingelheim Investigational Site
city: Schkeuditz
country: Germany
facility: 1245.48.49007 Boehringer Ingelheim Investigational Site
city: Teuchern
country: Germany
facility: 1245.48.49006 Boehringer Ingelheim Investigational Site
city: Baabda
country: Lebanon
facility: 1245.48.96003 Boehringer Ingelheim Investigational Site
city: Beirut
country: Lebanon
facility: 1245.48.96001 Boehringer Ingelheim Investigational Site
city: Lebanon
country: Lebanon
facility: 1245.48.96002 Boehringer Ingelheim Investigational Site
city: Breda
country: Netherlands
facility: 1245.48.31011 Boehringer Ingelheim Investigational Site
city: Eindhoven
country: Netherlands
facility: 1245.48.31012 Boehringer Ingelheim Investigational Site
city: Etten Leur
country: Netherlands
facility: 1245.48.31009 Boehringer Ingelheim Investigational Site
city: Groningen
country: Netherlands
facility: 1245.48.31014 Boehringer Ingelheim Investigational Site
city: Leiderdorp
country: Netherlands
facility: 1245.48.31013 Boehringer Ingelheim Investigational Site
city: Oude Pekela
country: Netherlands
facility: 1245.48.31003 Boehringer Ingelheim Investigational Site
city: Rotterdam
country: Netherlands
facility: 1245.48.31016 Boehringer Ingelheim Investigational Site
city: Soerendonk
country: Netherlands
facility: 1245.48.31006 Boehringer Ingelheim Investigational Site
city: Spijkenisse
country: Netherlands
facility: 1245.48.31008 Boehringer Ingelheim Investigational Site
city: Swifterbant
country: Netherlands
facility: 1245.48.31002 Boehringer Ingelheim Investigational Site
city: Velp
country: Netherlands
facility: 1245.48.31015 Boehringer Ingelheim Investigational Site
city: Woerden
country: Netherlands
facility: 1245.48.31010 Boehringer Ingelheim Investigational Site
city: Zijndrecht
country: Netherlands
facility: 1245.48.31019 Boehringer Ingelheim Investigational Site
city: Zoetermeer
country: Netherlands
facility: 1245.48.31017 Boehringer Ingelheim Investigational Site
city: Elverum
country: Norway
facility: 1245.48.47008 Boehringer Ingelheim Investigational Site
city: Hamar
country: Norway
facility: 1245.48.47007 Boehringer Ingelheim Investigational Site
city: Kløfta
country: Norway
facility: 1245.48.47002 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1245.48.47001 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1245.48.47003 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1245.48.47004 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1245.48.47005 Boehringer Ingelheim Investigational Site
city: Sørumsand
country: Norway
facility: 1245.48.47006 Boehringer Ingelheim Investigational Site
city: Ålesund
country: Norway
facility: 1245.48.47009 Boehringer Ingelheim Investigational Site
city: Härnösand
country: Sweden
facility: 1245.48.46002 Boehringer Ingelheim Investigational Site
city: Järfälla
country: Sweden
facility: 1245.48.46004 Boehringer Ingelheim Investigational Site
city: Lund
country: Sweden
facility: 1245.48.46003 Boehringer Ingelheim Investigational Site
city: Malmö
country: Sweden
facility: 1245.48.46007 Boehringer Ingelheim Investigational Site
city: Skene
country: Sweden
facility: 1245.48.46006 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1245.48.46001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
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.
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.
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.