Diabetes Mellitus, Type 2Phase 3NCT01370005

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

A Phase 3 study testing BI 10773 in people with Diabetes Mellitus, Type 2 and Hypertension, run by Boehringer Ingelheim at 120 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2, Hypertension
What is being tested?: BI 10773
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 825 participants
Where: 120 sitesin 12 countries
Study dates: Jun 2011to Jul 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

120 sites in 12 countries.

Country

City, postcode or hospital

120 sites in 12 countries

United States35 sites

1245.48.10011 Boehringer Ingelheim Investigational Site
Addison, Illinois
1245.48.10005 Boehringer Ingelheim Investigational Site
Akron, Ohio
1245.48.10010 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
1245.48.10019 Boehringer Ingelheim Investigational Site
Arlington Heights, Illinois
1245.48.10036 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1245.48.10022 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1245.48.10034 Boehringer Ingelheim Investigational Site
Dallas, Texas
1245.48.10008 Boehringer Ingelheim Investigational Site
Davie, Florida
1245.48.10025 Boehringer Ingelheim Investigational Site
Edgewater, Florida
1245.48.10013 Boehringer Ingelheim Investigational Site
Erie, Pennsylvania
1245.48.10007 Boehringer Ingelheim Investigational Site
Houston, Texas
1245.48.10009 Boehringer Ingelheim Investigational Site
Houston, Texas
1245.48.10042 Boehringer Ingelheim Investigational Site
Houston, Texas
1245.48.10024 Boehringer Ingelheim Investigational Site
Huntsville, Alabama
1245.48.10001 Boehringer Ingelheim Investigational Site
Jacksonville, Florida
1245.48.10004 Boehringer Ingelheim Investigational Site
Kettering, Ohio
1245.48.10029 Boehringer Ingelheim Investigational Site
Knoxville, Tennessee
1245.48.10014 Boehringer Ingelheim Investigational Site
Lincoln, California
1245.48.10030 Boehringer Ingelheim Investigational Site
Long Beach, California
1245.48.10033 Boehringer Ingelheim Investigational Site
Long Beach, California
1245.48.10027 Boehringer Ingelheim Investigational Site
Los Angeles, California
1245.48.10012 Boehringer Ingelheim Investigational Site
Marietta, Georgia
1245.48.10015 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
1245.48.10016 Boehringer Ingelheim Investigational Site
Miami, Florida
1245.48.10003 Boehringer Ingelheim Investigational Site
Orem, Utah
1245.48.10035 Boehringer Ingelheim Investigational Site
Palm Harbor, Florida
1245.48.10018 Boehringer Ingelheim Investigational Site
Pensacola, Florida
1245.48.10002 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
1245.48.10032 Boehringer Ingelheim Investigational Site
Pinellas Park, Florida
1245.48.10020 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
1245.48.10023 Boehringer Ingelheim Investigational Site
Port Orchard, Washington
1245.48.10026 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1245.48.10041 Boehringer Ingelheim Investigational Site
Tustin, California
1245.48.10039 Boehringer Ingelheim Investigational Site
West Hills, California
1245.48.10017 Boehringer Ingelheim Investigational Site
Wichita, Kansas

Other trials in United States

Netherlands14 sites

1245.48.31011 Boehringer Ingelheim Investigational Site
Breda
1245.48.31012 Boehringer Ingelheim Investigational Site
Eindhoven
1245.48.31009 Boehringer Ingelheim Investigational Site
Etten-Leur
1245.48.31014 Boehringer Ingelheim Investigational Site
Groningen
1245.48.31013 Boehringer Ingelheim Investigational Site
Leiderdorp
1245.48.31003 Boehringer Ingelheim Investigational Site
Oude Pekela
1245.48.31016 Boehringer Ingelheim Investigational Site
Rotterdam
1245.48.31006 Boehringer Ingelheim Investigational Site
Soerendonk
1245.48.31008 Boehringer Ingelheim Investigational Site
Spijkenisse
1245.48.31002 Boehringer Ingelheim Investigational Site
Swifterbant
1245.48.31015 Boehringer Ingelheim Investigational Site
Velp
1245.48.31010 Boehringer Ingelheim Investigational Site
Woerden
1245.48.31019 Boehringer Ingelheim Investigational Site
Zijndrecht
1245.48.31017 Boehringer Ingelheim Investigational Site
Zoetermeer

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Denmark10 sites

1245.48.45006 Boehringer Ingelheim Investigational Site
Aalborg
1245.48.45009 Boehringer Ingelheim Investigational Site
Aarhus C
1245.48.45002 Boehringer Ingelheim Investigational Site
Elsinore
1245.48.45008 Boehringer Ingelheim Investigational Site
Hellerup
1245.48.45010 Boehringer Ingelheim Investigational Site
Hillerød
1245.48.45003 Boehringer Ingelheim Investigational Site
København NV
1245.48.45001 Boehringer Ingelheim Investigational Site
Rødovre Municipality
1245.48.45004 Boehringer Ingelheim Investigational Site
Rødovre Municipality
1245.48.45005 Boehringer Ingelheim Investigational Site
Vaerløse
1245.48.45007 Boehringer Ingelheim Investigational Site
Vojens

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Germany10 sites

1245.48.49001 Boehringer Ingelheim Investigational Site
Berlin
1245.48.49008 Boehringer Ingelheim Investigational Site
Berlin
1245.48.49003 Boehringer Ingelheim Investigational Site
Dresden
1245.48.49004 Boehringer Ingelheim Investigational Site
Hanover
1245.48.49005 Boehringer Ingelheim Investigational Site
Lüneburg
1245.48.49002 Boehringer Ingelheim Investigational Site
Mainz
1245.48.49010 Boehringer Ingelheim Investigational Site
Nuremberg
1245.48.49009 Boehringer Ingelheim Investigational Site
Pirna
1245.48.49007 Boehringer Ingelheim Investigational Site
Schkeuditz
1245.48.49006 Boehringer Ingelheim Investigational Site
Teuchern

Other trials in Germany

Norway9 sites

1245.48.47009 Boehringer Ingelheim Investigational Site
Ålesund
1245.48.47008 Boehringer Ingelheim Investigational Site
Elverum
1245.48.47007 Boehringer Ingelheim Investigational Site
Hamar
1245.48.47002 Boehringer Ingelheim Investigational Site
Kløfta
1245.48.47001 Boehringer Ingelheim Investigational Site
Oslo
1245.48.47003 Boehringer Ingelheim Investigational Site
Oslo
1245.48.47004 Boehringer Ingelheim Investigational Site
Oslo
1245.48.47005 Boehringer Ingelheim Investigational Site
Oslo
1245.48.47006 Boehringer Ingelheim Investigational Site
Sørumsand

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Czechia8 sites

1245.48.42003 Boehringer Ingelheim Investigational Site
Benešov
1245.48.42005 Boehringer Ingelheim Investigational Site
Brno
1245.48.42002 Boehringer Ingelheim Investigational Site
Mladá Boleslav
1245.48.42006 Boehringer Ingelheim Investigational Site
Neratovice
1245.48.42008 Boehringer Ingelheim Investigational Site
Olomouc
1245.48.42004 Boehringer Ingelheim Investigational Site
Opočno
1245.48.42007 Boehringer Ingelheim Investigational Site
Příbram
1245.48.42001 Boehringer Ingelheim Investigational Site
Slaný

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Canada7 sites

1245.48.20004 Boehringer Ingelheim Investigational Site
Brampton, Ontario
1245.48.20006 Boehringer Ingelheim Investigational Site
Etobicoke, Ontario
1245.48.20001 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
1245.48.20007 Boehringer Ingelheim Investigational Site
Oakville, Ontario
1245.48.20005 Boehringer Ingelheim Investigational Site
Thornhill, Ontario
1245.48.20003 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1245.48.20002 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba

Other trials in Canada

Finland7 sites

1245.48.35802 Boehringer Ingelheim Investigational Site
Helsinki
1245.48.35805 Boehringer Ingelheim Investigational Site
Joensuu
1245.48.35806 Boehringer Ingelheim Investigational Site
Kouvola
1245.48.35803 Boehringer Ingelheim Investigational Site
Oulu
1245.48.35804 Boehringer Ingelheim Investigational Site
Pori
1245.48.35801 Boehringer Ingelheim Investigational Site
Turku
1245.48.35807 Boehringer Ingelheim Investigational Site
Turku

Other trials in Finland

France7 sites

1245.48.33004 Boehringer Ingelheim Investigational Site
Angers
1245.48.33008 Boehringer Ingelheim Investigational Site
Bourges
1245.48.33005 Boehringer Ingelheim Investigational Site
Mont-de-Marsan
1245.48.33001 Boehringer Ingelheim Investigational Site
Nantes
1245.48.33006 Boehringer Ingelheim Investigational Site
Orthez
1245.48.33003 Boehringer Ingelheim Investigational Site
Tiercé
1245.48.33007 Boehringer Ingelheim Investigational Site
Tours

Other trials in France

Sweden6 sites

1245.48.46002 Boehringer Ingelheim Investigational Site
Härnösand
1245.48.46004 Boehringer Ingelheim Investigational Site
Järfälla
1245.48.46003 Boehringer Ingelheim Investigational Site
Lund
1245.48.46007 Boehringer Ingelheim Investigational Site
Malmö
1245.48.46006 Boehringer Ingelheim Investigational Site
Skene
1245.48.46001 Boehringer Ingelheim Investigational Site
Stockholm

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Estonia4 sites

1245.48.37203 Boehringer Ingelheim Investigational Site
Pärnu
1245.48.37201 Boehringer Ingelheim Investigational Site
Tallinn
1245.48.37202 Boehringer Ingelheim Investigational Site
Tallinn
1245.48.37204 Boehringer Ingelheim Investigational Site
Tallinn

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Lebanon3 sites

1245.48.96003 Boehringer Ingelheim Investigational Site
Baabda
1245.48.96001 Boehringer Ingelheim Investigational Site
Beirut
1245.48.96002 Boehringer Ingelheim Investigational Site
Lebanon

Other trials in Lebanon

About this study

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

Conditions: Diabetes Mellitus, Type 2, Hypertension
Being tested: Placebo, BI 10773
Medical subject headings: Diabetes Mellitus, Type 2, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Placebo matching BI 10773 low dose
BI 10773Drug
BI 10773 high dose once daily
PlaceboDrug
Placebo matching BI 10773 low dose
BI 10773Drug
BI 10773 low dose once daily
PlaceboDrug
Placebo matching BI 10773 high dose
PlaceboDrug
Placebo matching BI 10773 high dose

Study groups in NCT01370005
Study group	Role	What they receive
BI 10773 low dose	Experimental	BI 10773 low dose once daily Receives: Drug: Placebo; Drug: BI 10773
BI 10773 high dose	Experimental	BI 10773 high dose once daily Receives: Drug: BI 10773; Drug: Placebo
Placebo	Placebo comparator	Placebo tablets matching BI 10773 Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (13)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Jul 2012

First posted9 Jun 2011 (estimated)
Study startJun 2011
Primary completionJul 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 825 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01370005
Sponsor's protocol ID: 1245.48
Other IDs: 2011-000347-25
Status last verified: Jan 2016
First submitted: 8 Jun 2011
Last updated: 22 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Boehringer Ingelheim Policy on Transparency and Publication http://trials.boehringer-ingelheim.com/transparency\_policy.html

Publications

Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PubMed 38770818
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.
PubMed 35472672
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.
PubMed 27977392
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.
PubMed 25271206

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01370005
Acronym / sponsor ID: 1245.48
Conditions: Diabetes Mellitus, Type 2, Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 825 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Jun 2011
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 9 Jun 2011 (estimated)
Results: Posted 17 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
BI 10773 low dose	Experimental	Drug: Placebo, Drug: BI 10773BI 10773 low dose once daily
BI 10773 high dose	Experimental	Drug: BI 10773, Drug: PlaceboBI 10773 high dose once daily
Placebo	Placebo comparator	Drug: PlaceboPlacebo tablets matching BI 10773

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPlacebo matching BI 10773 low dose	Drug	BI 10773 low dose
BI 10773BI 10773 high dose once daily	Drug	BI 10773 high dose
PlaceboPlacebo matching BI 10773 low dose	Drug	Placebo
BI 10773BI 10773 low dose once daily	Drug	BI 10773 low dose
PlaceboPlacebo matching BI 10773 high dose	Drug	BI 10773 high dose
PlaceboPlacebo matching BI 10773 high dose	Drug	Placebo

Primary outcome

HbA1c Change From Baseline
Time frame: Baseline and 12 weeks
Change from baseline in HbA1c after 12 weeks of treatment.
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).

13 secondary outcomes

Mean 24-hour Diastolic Blood Pressure Change From Baseline
Time frame: Baseline and 12 weeks
Proportion of Patients With HbA1c <7%
Time frame: Baseline and 12 weeks
Fasting Plasma Glucose (FPG) Change From Baseline
Time frame: Baseline and 12 weeks
Body Weight Change From Baseline
Time frame: Baseline and 12 weeks
Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline
Time frame: Baseline and 12 weeks
Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline
Time frame: Baseline and 12 weeks
Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline
Time frame: Baseline and 12 weeks
Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline
Time frame: Baseline and 12 weeks
Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline
Time frame: Baseline and 12 weeks
Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline
Time frame: Baseline and 12 weeks
Proportion of Patients Reaching Blood Pressure <130/80 mmHg
Time frame: Baseline and 12 weeks
Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight
Time frame: Baseline and 12 weeks
Orthostatic Blood Pressure
Time frame: Baseline and 12 weeks

Results and safety

Results posted to the registry on 17 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	272	256
Empa 10mg	276	265
Empa 25mg	277	266

Primary outcome: HbA1c Change From Baseline

Time frame: Baseline and 12 weeks. Mean (Standard Deviation). Unit: percentage of HbA1c

Measure	Placebo n = 271	Empa 10mg n = 276	Empa 25mg n = 276
Value	0.03 (0.60)	-0.59 (0.63)	-0.63 (0.62)

Placebo vs Empa 10mg: Mean Difference (Final Values): -0.62 (95% CI -0.72 to -0.52), p <0.0001, ANCOVA
Placebo vs Empa 25mg: Mean Difference (Final Values): -0.65 (95% CI -0.75 to -0.55), p <0.0001, ANCOVA

Population analysed: Full analysis set (FAS), which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.

Primary outcome: Mean 24-hour Systolic Blood Pressure Change From Baseline

Time frame: Baseline and 12 weeks. Mean (Standard Deviation). Unit: mmHg

Measure	Placebo n = 271	Empa 10mg n = 276	Empa 25mg n = 276
Value	0.42 (8.25)	-2.99 (8.86)	-3.59 (9.30)

Placebo vs Empa 10mg: Mean Difference (Final Values): -3.44 (95% CI -4.78 to -2.09), p <0.0001, ANCOVA
Placebo vs Empa 25mg: Mean Difference (Final Values): -4.16 (95% CI -5.50 to -2.83), p <0.0001, ANCOVA

Population analysed: FAS, which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised. Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: From drug administration until last drug administration plus seven days, up to 171 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	7 of 272 (2.6%)	43 of 272 (15.8%)	Not reported
Empa 10mg	3 of 276 (1.1%)	42 of 276 (15.2%)	Not reported
Empa 25mg	4 of 276 (1.4%)	55 of 276 (19.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38770818Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Derived from this study: PubMed 35472672Tuttle 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.
Derived from this study: PubMed 27977392Mancia 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.
Derived from this study: PubMed 25271206Tikkanen 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.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Boehringer Ingelheim Policy on Transparency and Publication http://trials.boehringer-ingelheim.com/transparency_policy.html

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

120 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI 10773 in people with Diabetes Mellitus, Type 2 and Hypertension, run by Boehringer Ingelheim at 120 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Netherlands, Denmark, Germany, Norway and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c Change From Baseline (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01370005, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.