Diabetes Mellitus, Type 2Phase 3NCT01778049

Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes

A Phase 3 study testing BI 10773 and BI 10773 / BI 1356 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 114 sites in 11 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: BI 10773 and BI 10773 / BI 1356
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 708 participants
Where: 114 sitesin 11 countries
Study dates: Jan 2013to Mar 2015
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

Signed and dated ICF (Informed Consent Form)
Male or female on diet and exercise regime and on stable background metformin > or equal to 1500 mg or maximun dose according to local label
HBA1c (Glicoslated Hemoglobin) > or equal to 8% and < or equal to 10.5 % at Visit 1
HbA1c > or equal to 7 and < or equal to 10.5 at Visit 4
Age > or equal to 18 years
BMI (Body Mass Index) < or equal to 45

Who cannot join

Uncontrolled hyperglycemia during open label period and placebo add on "run-in" period
Use of any other antidiabetic
Renal function below 60 ml/min/1.73 m2
Antiobesity drugs or aggresive diets
Gastorintestinal surgeries
Current systemic steroids or uncontrolled endocrine disorders other than Diabetes Type 2
Acute coronary syndrome and stroke within 3 months of informed consent
Known allergies to DPP-IV (Dypeptidil Peptidase IV) or SGLT-2 (Sodium Glucose Transporter 2) inhibitors

Trial locations and contacts

114 sites in 11 countries.

Country

City, postcode or hospital

114 sites in 11 countries

United States24 sites

1275.10.01012 Boehringer Ingelheim Investigational Site
Avon, Indiana
1275.10.01005 Boehringer Ingelheim Investigational Site
Bismarck, North Dakota
1275.10.01019 Boehringer Ingelheim Investigational Site
Chino, California
1275.10.01017 Boehringer Ingelheim Investigational Site
Conyers, Georgia
1275.10.01018 Boehringer Ingelheim Investigational Site
Draper, Utah
1275.10.01010 Boehringer Ingelheim Investigational Site
Elkton, Maryland
1275.10.01008 Boehringer Ingelheim Investigational Site
Huntington Beach, California
1275.10.01011 Boehringer Ingelheim Investigational Site
Miami, Florida
1275.10.01013 Boehringer Ingelheim Investigational Site
Muncie, Indiana
1275.10.01014 Boehringer Ingelheim Investigational Site
North Richland Hills, Texas
1275.10.01020 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
1275.10.01009 Boehringer Ingelheim Investigational Site
Orlando, Florida
1275.10.01023 Boehringer Ingelheim Investigational Site
Oviedo, Florida
1275.10.01022 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
1275.10.01015 Boehringer Ingelheim Investigational Site
Richmond, Virginia
1275.10.01007 Boehringer Ingelheim Investigational Site
Salisbury, North Carolina
1275.10.01003 Boehringer Ingelheim Investigational Site
San Diego, California
1275.10.01024 Boehringer Ingelheim Investigational Site
San Diego, California
1275.10.01016 Boehringer Ingelheim Investigational Site
Snellville, Georgia
1275.10.01001 Boehringer Ingelheim Investigational Site
Stevensville, Michigan
1275.10.01002 Boehringer Ingelheim Investigational Site
Sylmar, California
1275.10.01006 Boehringer Ingelheim Investigational Site
Tamarac, Florida
1275.10.01021 Boehringer Ingelheim Investigational Site
Union, South Carolina
1275.10.01025 Boehringer Ingelheim Investigational Site
Virginia Beach, Virginia

Other trials in United States

Italy15 sites

1275.10.39005 Boehringer Ingelheim Investigational Site
Ancona
1275.10.39006 Boehringer Ingelheim Investigational Site
Catania
1275.10.39009 Boehringer Ingelheim Investigational Site
Catania
1275.10.39014 Boehringer Ingelheim Investigational Site
Catania
1275.10.39007 Boehringer Ingelheim Investigational Site
Latina
1275.10.39012 Boehringer Ingelheim Investigational Site
Milan
1275.10.39013 Boehringer Ingelheim Investigational Site
Milan
1275.10.39015 Boehringer Ingelheim Investigational Site
Olbia (OT)
1275.10.39016 Boehringer Ingelheim Investigational Site
Orbassano (TO)
1275.10.39004 Boehringer Ingelheim Investigational Site
Palermo
1275.10.39003 Boehringer Ingelheim Investigational Site
Pistoia
1275.10.39008 Boehringer Ingelheim Investigational Site
Roma
1275.10.39001 Boehringer Ingelheim Investigational Site
Sesto San Giovanni (MI)
1275.10.39010 Boehringer Ingelheim Investigational Site
Siena
1275.10.39011 Boehringer Ingelheim Investigational Site
Terni

Other trials in Italy

Argentina13 sites

1275.10.54005 Boehringer Ingelheim Investigational Site
Caba
1275.10.54012 Boehringer Ingelheim Investigational Site
Caba
1275.10.54002 Boehringer Ingelheim Investigational Site
Capital Federal
1275.10.54007 Boehringer Ingelheim Investigational Site
Capital Federal
1275.10.54013 Boehringer Ingelheim Investigational Site
Capital Federal
1275.10.54006 Boehringer Ingelheim Investigational Site
Córdoba
1275.10.54008 Boehringer Ingelheim Investigational Site
Córdoba
1275.10.54011 Boehringer Ingelheim Investigational Site
Córdoba
1275.10.54003 Boehringer Ingelheim Investigational Site
Godoy Cruz, Mendoza
1275.10.54009 Boehringer Ingelheim Investigational Site
Mar del Plata
1275.10.54004 Boehringer Ingelheim Investigational Site
Salta
1275.10.54001 Boehringer Ingelheim Investigational Site
San Isidro
1275.10.54010 Boehringer Ingelheim Investigational Site
Zárate

Other trials in Argentina

Canada13 sites

1275.10.02013 Boehringer Ingelheim Investigational Site
Burlington, Ontario
1275.10.02003 Boehringer Ingelheim Investigational Site
Chilliwack, British Columbia
1275.10.02009 Boehringer Ingelheim Investigational Site
Coquitlam, British Columbia
1275.10.02011 Boehringer Ingelheim Investigational Site
Drummondville, Quebec
1275.10.02004 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1275.10.02007 Boehringer Ingelheim Investigational Site
Greater Sudbury, Ontario
1275.10.02005 Boehringer Ingelheim Investigational Site
Moncton, New Brunswick
1275.10.02010 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1275.10.02001 Boehringer Ingelheim Investigational Site
Red Deer, Alberta
1275.10.02002 Boehringer Ingelheim Investigational Site
Strathroy, Ontario
1275.10.02012 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1275.10.02006 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba
1275.10.02008 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba

Other trials in Canada

Germany13 sites

1275.10.49007 Boehringer Ingelheim Investigational Site
Aßlar
1275.10.49014 Boehringer Ingelheim Investigational Site
Berlin
1275.10.49004 Boehringer Ingelheim Investigational Site
Cologne
1275.10.49016 Boehringer Ingelheim Investigational Site
Elsterwerda
1275.10.49012 Boehringer Ingelheim Investigational Site
Hamburg
1275.10.49005 Boehringer Ingelheim Investigational Site
Hatten
1275.10.49008 Boehringer Ingelheim Investigational Site
Kiel Kronshagen
1275.10.49010 Boehringer Ingelheim Investigational Site
Lübeck
1275.10.49003 Boehringer Ingelheim Investigational Site
Münster
1275.10.49006 Boehringer Ingelheim Investigational Site
Pirna
1275.10.49013 Boehringer Ingelheim Investigational Site
Saint Ingbert/Oberwürzbach
1275.10.49001 Boehringer Ingelheim Investigational Site
Unterschneidheim
1275.10.49015 Boehringer Ingelheim Investigational Site
Wangen

Other trials in Germany

Spain12 sites

1275.10.34003 Boehringer Ingelheim Investigational Site
Barcelona
1275.10.34004 Boehringer Ingelheim Investigational Site
Canet de Mar
1275.10.34008 Boehringer Ingelheim Investigational Site
Centelles
1275.10.34009 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat (Barcelona)
1275.10.34012 Boehringer Ingelheim Investigational Site
La Roca del Vallès
1275.10.34006 Boehringer Ingelheim Investigational Site
Madrid
1275.10.34001 Boehringer Ingelheim Investigational Site
Málaga
1275.10.34010 Boehringer Ingelheim Investigational Site
Málaga
1275.10.34011 Boehringer Ingelheim Investigational Site
Mataró
1275.10.34013 Boehringer Ingelheim Investigational Site
Pineda de Mar
1275.10.34002 Boehringer Ingelheim Investigational Site
Sabadell
1275.10.34005 Boehringer Ingelheim Investigational Site
Tarragona

Other trials in Spain

Ukraine7 sites

1275.10.38006 Boehringer Ingelheim Investigational Site
Chernivtsi
1275.10.38007 Boehringer Ingelheim Investigational Site
Dnipro
1275.10.38002 Boehringer Ingelheim Investigational Site
Kiev
1275.10.38003 Boehringer Ingelheim Investigational Site
Kiev
1275.10.38004 Boehringer Ingelheim Investigational Site
Lviv
1275.10.38001 Boehringer Ingelheim Investigational Site
Vinnitsa
1275.10.38005 Boehringer Ingelheim Investigational Site
Zhytomyr

Other trials in Ukraine

Portugal6 sites

1275.10.35104 Boehringer Ingelheim Investigational Site
Cantanhede
1275.10.35112 Boehringer Ingelheim Investigational Site
Porto
1275.10.35103 Boehringer Ingelheim Investigational Site
Sandim
1275.10.35105 Boehringer Ingelheim Investigational Site
Tornada
1275.10.35108 Boehringer Ingelheim Investigational Site
Valadares
1275.10.35101 Boehringer Ingelheim Investigational Site
Vila Nova de Gaia

Other trials in Portugal

Russia6 sites

1275.10.07004 Boehringer Ingelheim Investigational Site
Chelyabinsk
1275.10.07003 Boehringer Ingelheim Investigational Site
Saint Petersburg
1275.10.07006 Boehringer Ingelheim Investigational Site
Saint Petersburg
1275.10.07001 Boehringer Ingelheim Investigational Site
Saratov
1275.10.07005 Boehringer Ingelheim Investigational Site
Saratov
1275.10.07002 Boehringer Ingelheim Investigational Site
Yaroslavl

Other trials in Russia

Australia4 sites

1275.10.61008 Boehringer Ingelheim Investigational Site
Cardiff, New South Wales
1275.10.61002 Boehringer Ingelheim Investigational Site
East Ringwood, Victoria
1275.10.61001 Boehringer Ingelheim Investigational Site
Heidelberg Heights, Victoria
1275.10.61009 Boehringer Ingelheim Investigational Site
Mirrabooka, Western Australia

Other trials in Australia

El Salvador1 site

1275.10.34014 Boehringer Ingelheim Investigational Site
Ávila

Other trials in El Salvador

About this study

Official title: A Phase III, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Linagliptin 5 mg Compared to Placebo, Administered as Oral Fixed Dose Combination With Empagliflozin 10 mg or 25 mg for 24 Weeks, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks of Treatment With Empagliflozin 10 mg or 25 mg on Metformin Background Therapy

The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.

Conditions: Diabetes Mellitus, Type 2
Being tested: BI 10773, BI 10773 Placebo, BI 10773 / BI 1356, BI 10773 / BI 1356 Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

BI 10773Drug
Empagliflozin active
BI 10773 PlaceboDrug
Empagliflozin placebo
BI 10773 / BI 1356Drug
Empagliflozin / Linagliptin 25/5 mg Dose FDC active
BI 10773Drug
Empagliflozin active
BI 10773 / BI 1356Drug
Empagliflozin / Linagliptin 10/5 mg Dose FDC active
BI 10773 / BI 1356 PlaceboDrug
Empagliflozin / Linagliptin 10/5 mg Dose placebo FDC
BI 10773Drug
Empagliflozin active
BI 10773Drug
Empagliflozin active
BI 10773Drug
Empagliflozin active
BI 10773 / BI 1356 PlaceboDrug
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
BI 10773 PlaceboDrug
Empagliflozin placebo
BI 10773 / BI 1356 PlaceboDrug
Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
BI 10773Drug
Empagliflozin active
BI 10773 / BI 1356 PlaceboDrug
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo

Study groups in NCT01778049
Study group	Role	What they receive
Empagliflozin 10 mg dose	Experimental	Empagliflozin open label treatment period Receives: Drug: BI 10773
Placebo add on 10 mg dose	Experimental	Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in Receives: Drug: BI 10773 / BI 1356 Placebo; Drug: BI 10773
Empagliflozin/Linagliptin 25/5 mg Dose	Experimental	Empagliflozin / Linagliptin 25/5 mg Dose FDC active Receives: Drug: BI 10773 / BI 1356; Drug: BI 10773 Placebo
Empagliflozin/Linagliptin 10/5 mg Dose.	Experimental	Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo Receives: Drug: BI 10773 / BI 1356 Placebo; Drug: BI 10773
Empagliflozin/Linagliptin 10/5 mg Dose	Experimental	Empagliflozin / Linagliptin 10/5 mg Dose FDC active Receives: Drug: BI 10773 Placebo; Drug: BI 10773 / BI 1356
Empagliflozin 25 mg dose	Experimental	Empagliflozin open label treatment period Receives: Drug: BI 10773
Empagliflozin/Linagliptin 25/5 mg Dose.	Experimental	Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo Receives: Drug: BI 10773; Drug: BI 10773 / BI 1356 Placebo
Placebo add on 25 mg dose	Experimental	Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in Receives: Drug: BI 10773; Drug: BI 10773 / BI 1356 Placebo

What is being measured

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

Change From Baseline of HbA1c After 24 Weeks of Treatment.
Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term "baseline" was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as "pre-treatment". Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference.
Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial.
Measured: Baseline and 24 weeks

Secondary outcomes (1)

Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks.
Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication, i.e. FPG change from baseline at Week 24.
Measured: Baseline and 24 weeks

Timeline

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

Jan 2013Mar 2015

First posted29 Jan 2013 (estimated)
Study startJan 2013
Primary completionMar 2015
Study completionMar 2015

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 (1)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: 708 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01778049
Sponsor's protocol ID: 1275.10
Other IDs: 2012-002271-34
Status last verified: Mar 2016
First submitted: 24 Jan 2013
Last updated: 4 Apr 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Tinahones FJ, Gallwitz B, Nordaby M, Gotz S, Maldonado-Lutomirsky M, Woerle HJ, Broedl UC. Linagliptin as add-on to empagliflozin and metformin in patients with type 2 diabetes: Two 24-week randomized, double-blind, double-dummy, parallel-group trials. Diabetes Obes Metab. 2017 Feb;19(2):266-274. doi: 10.1111/dom.12814. Epub 2016 Nov 24.
PubMed 27762093

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 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Linagliptin 5 mg Compared to Placebo, Administered as Oral Fixed Dose Combination With Empagliflozin 10 mg or 25 mg for 24 Weeks, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks of Treatment With Empagliflozin 10 mg or 25 mg on Metformin Background Therapy
ClinicalTrials.gov ID: NCT01778049
Acronym / sponsor ID: 1275.10
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 708 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Jan 2013
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 29 Jan 2013 (estimated)
Results: Posted 4 Apr 2016

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: 8

Arm	Type	Receives
Empagliflozin 10 mg dose	Experimental	Drug: BI 10773Empagliflozin open label treatment period
Placebo add on 10 mg dose	Experimental	Drug: BI 10773 / BI 1356 Placebo, Drug: BI 10773Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in
Empagliflozin/Linagliptin 25/5 mg Dose	Experimental	Drug: BI 10773 / BI 1356, Drug: BI 10773 PlaceboEmpagliflozin / Linagliptin 25/5 mg Dose FDC active
Empagliflozin/Linagliptin 10/5 mg Dose.	Experimental	Drug: BI 10773 / BI 1356 Placebo, Drug: BI 10773Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
Empagliflozin/Linagliptin 10/5 mg Dose	Experimental	Drug: BI 10773 Placebo, Drug: BI 10773 / BI 1356Empagliflozin / Linagliptin 10/5 mg Dose FDC active
Empagliflozin 25 mg dose	Experimental	Drug: BI 10773Empagliflozin open label treatment period
Empagliflozin/Linagliptin 25/5 mg Dose.	Experimental	Drug: BI 10773, Drug: BI 10773 / BI 1356 PlaceboEmpagliflozin / Linagliptin 25/5 mg Dose FDC placebo
Placebo add on 25 mg dose	Experimental	Drug: BI 10773, Drug: BI 10773 / BI 1356 PlaceboEmpagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in

Who may qualify

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

Key inclusion criteria (6 listed)

Signed and dated ICF (Informed Consent Form)
Male or female on diet and exercise regime and on stable background metformin > or equal to 1500 mg or maximun dose according to local label
HBA1c (Glicoslated Hemoglobin) > or equal to 8% and < or equal to 10.5 % at Visit 1
HbA1c > or equal to 7 and < or equal to 10.5 at Visit 4
Age > or equal to 18 years

Key exclusion criteria (8 listed)

Uncontrolled hyperglycemia during open label period and placebo add on "run-in" period
Use of any other antidiabetic
Renal function below 60 ml/min/1.73 m2
Antiobesity drugs or aggresive diets
Gastorintestinal surgeries

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
BI 10773Empagliflozin active	Drug	Placebo add on 25 mg dose
BI 10773 PlaceboEmpagliflozin placebo	Drug	Empagliflozin/Linagliptin 10/5 mg Dose
BI 10773 / BI 1356Empagliflozin / Linagliptin 25/5 mg Dose FDC active	Drug	Empagliflozin/Linagliptin 25/5 mg Dose
BI 10773Empagliflozin active	Drug	Empagliflozin 10 mg dose
BI 10773 / BI 1356Empagliflozin / Linagliptin 10/5 mg Dose FDC active	Drug	Empagliflozin/Linagliptin 10/5 mg Dose
BI 10773 / BI 1356 PlaceboEmpagliflozin / Linagliptin 10/5 mg Dose placebo FDC	Drug	Placebo add on 10 mg dose
BI 10773Empagliflozin active	Drug	Placebo add on 10 mg dose
BI 10773Empagliflozin active	Drug	Empagliflozin 25 mg dose
BI 10773Empagliflozin active	Drug	Empagliflozin/Linagliptin 25/5 mg Dose.
BI 10773 / BI 1356 PlaceboEmpagliflozin / Linagliptin 25/5 mg Dose FDC placebo	Drug	Empagliflozin/Linagliptin 25/5 mg Dose.
BI 10773 PlaceboEmpagliflozin placebo	Drug	Empagliflozin/Linagliptin 25/5 mg Dose
BI 10773 / BI 1356 PlaceboEmpagliflozin / Linagliptin 10/5 mg Dose FDC placebo	Drug	Empagliflozin/Linagliptin 10/5 mg Dose.
BI 10773Empagliflozin active	Drug	Empagliflozin/Linagliptin 10/5 mg Dose.
BI 10773 / BI 1356 PlaceboEmpagliflozin / Linagliptin 25/5 mg Dose FDC placebo	Drug	Placebo add on 25 mg dose

Primary outcome

Change From Baseline of HbA1c After 24 Weeks of Treatment.
Time frame: Baseline and 24 weeks
Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term "baseline" was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as "pre-treatment". Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference. Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial.

1 secondary outcome

Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks.
Time frame: Baseline and 24 weeks

Results and safety

Results posted to the registry on 4 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Empa 10 mg OL	354	256
Empa 25 mg OL	355	226
Lina5 (E10)	0	0
Plc (E10)	0	0
Lina5 (E25)	0	0
Plc (E25)	0	0

Primary outcome: Change From Baseline of HbA1c After 24 Weeks of Treatment.

Time frame: Baseline and 24 weeks. Least squares mean (Standard Error). Unit: Percentage of HbA1c

Measure	Lina5 (E10) n = 111	Plc (E10) n = 110	Lina5 (E25) n = 98	Plc (E25) n = 98
Value	-0.53 (0.07)	-0.21 (0.07)	-0.58 (0.07)	-0.10 (0.07)

Lina5 (E10) vs Plc (E10): Mean Difference (Final Values): -0.32 (95% CI -0.52 to -0.13), p = 0.0013, Mixed Model Repeated Measure (MMRM)
Lina5 (E25) vs Plc (E25): Mean Difference (Final Values): -0.47 (95% CI -0.66 to -0.28), p <0.0001, MMRM

Population analysed: FAS (OC)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first drug administration until 7 days after the last drug administration, up to 212 days (OL treatment period) and 205 days (double blind treatment period).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empa 10 mg OL	12 of 352 (3.4%)	47 of 352 (13.4%)	Not reported
Empa 25 mg OL	12 of 354 (3.4%)	38 of 354 (10.7%)	Not reported
Lina5 (E10)	4 of 126 (3.2%)	22 of 126 (17.5%)	Not reported
Plc (E10)	5 of 128 (3.9%)	10 of 128 (7.8%)	Not reported
Lina5 (E25)	3 of 112 (2.7%)	18 of 112 (16.1%)	Not reported
Plc (E25)	4 of 112 (3.6%)	21 of 112 (18.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27762093Tinahones FJ, Gallwitz B, Nordaby M, Gotz S, Maldonado-Lutomirsky M, Woerle HJ, Broedl UC. Linagliptin as add-on to empagliflozin and metformin in patients with type 2 diabetes: Two 24-week randomized, double-blind, double-dummy, parallel-group trials. Diabetes Obes Metab. 2017 Feb;19(2):266-274. doi: 10.1111/dom.12814. Epub 2016 Nov 24.

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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

114 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI 10773 and BI 10773 / BI 1356 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 114 sites in 11 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 6 inclusion and 8 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 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in United States, Italy, Argentina, Canada, Germany and 6 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. 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 4 Apr 2016). 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?

Change From Baseline of HbA1c After 24 Weeks of Treatment. (time frame: Baseline and 24 weeks). 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 NCT01778049, which also lists 1 linked publication.

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 4 Apr 2016.