Diabetes Mellitus, Type 2Phase 3NCT01422876

Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients

A Phase 3 study testing high dose FDC and BI 10773 high dose in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 211 sites in 22 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 use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: high dose FDC and BI 10773 high dose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,405 participants
Where: 211 sitesin 22 countries
Study dates: Aug 2011to Sep 2013
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

Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients on diet and exercise regimen who are drug-naïve (defined as absence of any oral antidiabetic therapy, glucagon like peptide-1 analog or insulin for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Glycosylated hemoglobin (HbA1c) = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3 mmol/mol) at Visit 1 (screening)

Who cannot join

Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
Any other antidiabetic drug within 12 weeks prior to randomization (except metformin background therapy as defined via inclusion criterion 2)
Acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction and unstable angina pectoris), stroke or (transient ischemic attack) TIA within 3 months prior to informed consent

Trial locations and contacts

211 sites in 22 countries.

Country

City, postcode or hospital

211 sites in 22 countries

United States112 sites

1275.1.01100 Boehringer Ingelheim Investigational Site
Addison, Illinois
1275.1.01001 Boehringer Ingelheim Investigational Site
Akron, Ohio
1275.1.01057 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
1275.1.01084 Boehringer Ingelheim Investigational Site
Altoona, Pennsylvania
1275.1.01011 Boehringer Ingelheim Investigational Site
Asheboro, North Carolina
1275.1.01039 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
1275.1.01049 Boehringer Ingelheim Investigational Site
Austin, Texas
1275.1.01080 Boehringer Ingelheim Investigational Site
Austin, Texas
1275.1.01002 Boehringer Ingelheim Investigational Site
Binghamton, New York
1275.1.01103 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1275.1.01081 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
1275.1.01008 Boehringer Ingelheim Investigational Site
Bountiful, Utah
1275.1.01015 Boehringer Ingelheim Investigational Site
Brentwood, Tennessee
1275.1.01052 Boehringer Ingelheim Investigational Site
Burlington, North Carolina
1275.1.01086 Boehringer Ingelheim Investigational Site
Cerritos, California
1275.1.01093 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
1275.1.01045 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1275.1.01031 Boehringer Ingelheim Investigational Site
Chattanooga, Tennessee
1275.1.01067 Boehringer Ingelheim Investigational Site
Chula Vista, California
1275.1.01032 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1275.1.01061 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1275.1.01116 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1275.1.01078 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado
1275.1.01124 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado
1275.1.01016 Boehringer Ingelheim Investigational Site
Columbus, Ohio
1275.1.01102 Boehringer Ingelheim Investigational Site
Columbus, Ohio
1275.1.01082 Boehringer Ingelheim Investigational Site
Corvallis, Oregon
1275.1.01017 Boehringer Ingelheim Investigational Site
Dayton, Ohio
1275.1.01036 Boehringer Ingelheim Investigational Site
Dayton, Ohio
1275.1.01030 Boehringer Ingelheim Investigational Site
Delaware, Ohio
1275.1.01010 Boehringer Ingelheim Investigational Site
Denver, Colorado
1275.1.01048 Boehringer Ingelheim Investigational Site
Denver, Colorado
1275.1.01042 Boehringer Ingelheim Investigational Site
Des Moines, Iowa
1275.1.01013 Boehringer Ingelheim Investigational Site
Elizabeth, New Jersey
1275.1.01109 Boehringer Ingelheim Investigational Site
Encino, California
1275.1.01020 Boehringer Ingelheim Investigational Site
Endwell, New York
1275.1.01038 Boehringer Ingelheim Investigational Site
Fleetwood, Pennsylvania
1275.1.01122 Boehringer Ingelheim Investigational Site
Florence, South Carolina
1275.1.01095 Boehringer Ingelheim Investigational Site
Flushing, New York
1275.1.01107 Boehringer Ingelheim Investigational Site
Foley, Alabama
1275.1.01012 Boehringer Ingelheim Investigational Site
Fresno, California
1275.1.01073 Boehringer Ingelheim Investigational Site
Gainesville, Florida
1275.1.01062 Boehringer Ingelheim Investigational Site
Glens Falls, New York
1275.1.01033 Boehringer Ingelheim Investigational Site
Great Falls, Montana
1275.1.01055 Boehringer Ingelheim Investigational Site
Groveport, Ohio
1275.1.01050 Boehringer Ingelheim Investigational Site
Harbor City, California
1275.1.01099 Boehringer Ingelheim Investigational Site
Henderson, Nevada
1275.1.01063 Boehringer Ingelheim Investigational Site
Hialeah, Florida
1275.1.01077 Boehringer Ingelheim Investigational Site
Hialeah, Florida
1275.1.01005 Boehringer Ingelheim Investigational Site
Hodges, South Carolina
1275.1.01029 Boehringer Ingelheim Investigational Site
Houston, Texas
1275.1.01053 Boehringer Ingelheim Investigational Site
Houston, Texas
1275.1.01106 Boehringer Ingelheim Investigational Site
Houston, Texas
1275.1.01056 Boehringer Ingelheim Investigational Site
Huntington Park, California
1275.1.01125 Boehringer Ingelheim Investigational Site
Hyattsville, Maryland
1275.1.01090 Boehringer Ingelheim Investigational Site
Inverness, Florida
1275.1.01054 Boehringer Ingelheim Investigational Site
Jacksonville, Florida
1275.1.01101 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada
1275.1.01114 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada
1275.1.01123 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada
1275.1.01028 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas
1275.1.01021 Boehringer Ingelheim Investigational Site
Long Beach, California
1275.1.01024 Boehringer Ingelheim Investigational Site
Los Angeles, California
1275.1.01112 Boehringer Ingelheim Investigational Site
Los Angeles, California
1275.1.01092 Boehringer Ingelheim Investigational Site
Maitland, Florida
1275.1.01007 Boehringer Ingelheim Investigational Site
Marietta, Georgia
1275.1.01121 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
1275.1.01089 Boehringer Ingelheim Investigational Site
Mesa, Arizona
1275.1.01065 Boehringer Ingelheim Investigational Site
Miami, Florida
1275.1.01110 Boehringer Ingelheim Investigational Site
Miami, Florida
1275.1.01040 Boehringer Ingelheim Investigational Site
Miami Beach, Florida
1275.1.01025 Boehringer Ingelheim Investigational Site
Miami Lakes, Florida
1275.1.01043 Boehringer Ingelheim Investigational Site
Mobile, Alabama
1275.1.01066 Boehringer Ingelheim Investigational Site
Mobile, Alabama
1275.1.01006 Boehringer Ingelheim Investigational Site
New York, New York
1275.1.01111 Boehringer Ingelheim Investigational Site
Norcross, Georgia
1275.1.01034 Boehringer Ingelheim Investigational Site
Norman, Oklahoma
1275.1.01083 Boehringer Ingelheim Investigational Site
Oceanside, California
1275.1.01094 Boehringer Ingelheim Investigational Site
Orlando, Florida
1275.1.01068 Boehringer Ingelheim Investigational Site
Ormond Beach, Florida
1275.1.01059 Boehringer Ingelheim Investigational Site
Paducah, Kentucky
1275.1.01018 Boehringer Ingelheim Investigational Site
Pearland, Texas
1275.1.01047 Boehringer Ingelheim Investigational Site
Pell City, Alabama
1275.1.01051 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
1275.1.01019 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
1275.1.01079 Boehringer Ingelheim Investigational Site
Port Orange, Florida
1275.1.01085 Boehringer Ingelheim Investigational Site
Rochester, Michigan
1275.1.01096 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1275.1.01113 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1275.1.01120 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1275.1.01071 Boehringer Ingelheim Investigational Site
San Dimas, California
1275.1.01076 Boehringer Ingelheim Investigational Site
Savannah, Georgia
1275.1.01072 Boehringer Ingelheim Investigational Site
Scottdale, Pennsylvania
1275.1.01118 Boehringer Ingelheim Investigational Site
Selah, Washington
1275.1.01087 Boehringer Ingelheim Investigational Site
Shoreline, Washington
1275.1.01003 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana
1275.1.01091 Boehringer Ingelheim Investigational Site
South Chesterfield, Virginia
1275.1.01035 Boehringer Ingelheim Investigational Site
Southfield, Michigan
1275.1.01119 Boehringer Ingelheim Investigational Site
Spokane, Washington
1275.1.01105 Boehringer Ingelheim Investigational Site
Spring, Texas
1275.1.01069 Boehringer Ingelheim Investigational Site
Spring Hill, Tennessee
1275.1.01023 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1275.1.01027 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1275.1.01117 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
1275.1.01064 Boehringer Ingelheim Investigational Site
Tempe, Arizona
1275.1.01088 Boehringer Ingelheim Investigational Site
Tipton, Pennsylvania
1275.1.01044 Boehringer Ingelheim Investigational Site
Tustin, California
1275.1.01014 Boehringer Ingelheim Investigational Site
Uniontown, Pennsylvania
1275.1.01060 Boehringer Ingelheim Investigational Site
Uniontown, Pennsylvania
1275.1.01037 Boehringer Ingelheim Investigational Site
Waco, Texas
1275.1.01075 Boehringer Ingelheim Investigational Site
Wadsworth, Ohio
1275.1.01022 Boehringer Ingelheim Investigational Site
West Jordan, Utah

Other trials in United States

Romania10 sites

1275.1.40001 Boehringer Ingelheim Investigational Site
Alba Iulia
1275.1.40005 Boehringer Ingelheim Investigational Site
Baia Mare Maramures
1275.1.40004 Boehringer Ingelheim Investigational Site
Brasov
1275.1.40008 Boehringer Ingelheim Investigational Site
Bucharest
1275.1.40009 Boehringer Ingelheim Investigational Site
Bucharest
1275.1.40006 Boehringer Ingelheim Investigational Site
Cluj-Napoca
1275.1.40007 Boehringer Ingelheim Investigational Site
Galati
1275.1.40002 Boehringer Ingelheim Investigational Site
Oradea
1275.1.40010 Boehringer Ingelheim Investigational Site
Sibiu
1275.1.40003 Boehringer Ingelheim Investigational Site
Târgu Mureş

Other trials in Romania

Canada8 sites

1275.1.20008 Boehringer Ingelheim Investigational Site
Bathurst, New Brunswick
1275.1.20007 Boehringer Ingelheim Investigational Site
Bay Roberts, Newfoundland and Labrador
1275.1.20001 Boehringer Ingelheim Investigational Site
Brampton, Ontario
1275.1.20003 Boehringer Ingelheim Investigational Site
Drummondville, Quebec
1275.1.20006 Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador
1275.1.20002 Boehringer Ingelheim Investigational Site
Pointe-Claire, Quebec
1275.1.20004 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador
1275.1.20005 Boehringer Ingelheim Investigational Site
Toronto, Ontario

Other trials in Canada

Taiwan7 sites

1275.1.88006 Chang Gung Memorial Hospital-CY
Chiayi City
1275.1.88007 E-Da Hospital
Kaohsiung City
1275.1.88001 Cardinal Tien Hospital
New Taipei City
1275.1.88004 Taichung Veterans General Hospital
Taichung
1275.1.88008 Chi Mei Medical Center
Tainan
1275.1.88002 Far Eastern Memorial Hospital
Taipei
1275.1.88003 Taipei Chang Gung Memorial Hospital
Taipei

Other trials in Taiwan

Lebanon6 sites

1275.1.96004 Boehringer Ingelheim Investigational Site
Baabda
1275.1.96002 Boehringer Ingelheim Investigational Site
Beirut
1275.1.96003 Boehringer Ingelheim Investigational Site
Beirut
1275.1.96006 Boehringer Ingelheim Investigational Site
Beirut
1275.1.96008 Boehringer Ingelheim Investigational Site
Beirut
1275.1.96007 Boehringer Ingelheim Investigational Site
Saida

Other trials in Lebanon

Philippines6 sites

1275.1.63002 Boehringer Ingelheim Investigational Site
Davao City
1275.1.63001 Boehringer Ingelheim Investigational Site
Greenhills, San Juan
1275.1.63004 Boehringer Ingelheim Investigational Site
Manila
1275.1.63006 Boehringer Ingelheim Investigational Site
Marikina City
1275.1.63003 Boehringer Ingelheim Investigational Site
Pasay
1275.1.63005 Boehringer Ingelheim Investigational Site
Pasig

Other trials in Philippines

Russia6 sites

1275.1.70006 Boehringer Ingelheim Investigational Site
Arkhangelsk
1275.1.70001 Boehringer Ingelheim Investigational Site
Moscow
1275.1.70002 Boehringer Ingelheim Investigational Site
Saint Petersburg
1275.1.70003 Boehringer Ingelheim Investigational Site
Saint Petersburg
1275.1.70005 Boehringer Ingelheim Investigational Site
Saint Petersburg
1275.1.70004 Boehringer Ingelheim Investigational Site
Samara

Other trials in Russia

Argentina5 sites

1275.1.54001 Boehringer Ingelheim Investigational Site
Caba
1275.1.54005 Boehringer Ingelheim Investigational Site
Capital Federal
1275.1.54003 Boehringer Ingelheim Investigational Site
Córdoba
1275.1.54004 Boehringer Ingelheim Investigational Site
Mar del Plata
1275.1.54002 Boehringer Ingelheim Investigational Site
Mendoza

Other trials in Argentina

Estonia5 sites

1275.1.37206 Boehringer Ingelheim Investigational Site
Kiviõli
1275.1.37202 Boehringer Ingelheim Investigational Site
Pärnu
1275.1.37201 Boehringer Ingelheim Investigational Site
Tallinn
1275.1.37204 Boehringer Ingelheim Investigational Site
Tallinn
1275.1.37203 Boehringer Ingelheim Investigational Site
Viljandi County

Other trials in Estonia

Mexico5 sites

1275.1.52002 Boehringer Ingelheim Investigational Site
México
1275.1.52005 Boehringer Ingelheim Investigational Site
México
1275.1.52003 Boehringer Ingelheim Investigational Site
Monterrey
1275.1.52001 Boehringer Ingelheim Investigational Site
Pachuca
1275.1.52004 Boehringer Ingelheim Investigational Site
San Luis Potosí City

Other trials in Mexico

Peru5 sites

1275.1.51001 Boehringer Ingelheim Investigational Site
Arequipa
1275.1.51003 Boehringer Ingelheim Investigational Site
Ica
1275.1.51002 Boehringer Ingelheim Investigational Site
Lima
1275.1.51004 Boehringer Ingelheim Investigational Site
Lima
1275.1.51005 Boehringer Ingelheim Investigational Site
Lima

Other trials in Peru

Spain5 sites

1275.1.34004 Boehringer Ingelheim Investigational Site
Barcelona
1275.1.34005 Boehringer Ingelheim Investigational Site
Barcelona
1275.1.34002 Boehringer Ingelheim Investigational Site
Hospitalet de Llobegrat
1275.1.34003 Boehringer Ingelheim Investigational Site
Palma de Mallorca
1275.1.34006 Boehringer Ingelheim Investigational Site
Tarragona

Other trials in Spain

Colombia4 sites

1275.1.57004 Boehringer Ingelheim Investigational Site
Barranquilla
1275.1.57002 Boehringer Ingelheim Investigational Site
Bogotá
1275.1.57005 Boehringer Ingelheim Investigational Site
Bogotá
1275.1.57003 Boehringer Ingelheim Investigational Site
Tolima

Other trials in Colombia

Italy4 sites

1275.1.39003 Boehringer Ingelheim Investigational Site
Bassano Del Grappa (VI)
1275.1.39002 Boehringer Ingelheim Investigational Site
Fermo
1275.1.39001 Boehringer Ingelheim Investigational Site
Milan
1275.1.39004 Boehringer Ingelheim Investigational Site
Roma

Other trials in Italy

Poland4 sites

1275.1.48002 Boehringer Ingelheim Investigational Site
Lodz
1275.1.48004 Boehringer Ingelheim Investigational Site
Poznan
1275.1.48001 Boehringer Ingelheim Investigational Site
Warsaw
1275.1.48003 Boehringer Ingelheim Investigational Site
Warsaw

Other trials in Poland

Brazil3 sites

1275.1.55002 Boehringer Ingelheim Investigational Site
Joaquim Távora
1275.1.55001 Boehringer Ingelheim Investigational Site
Rio de Janeiro - RJ
1275.1.55005 Boehringer Ingelheim Investigational Site
São Paulo

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Bulgaria3 sites

1275.1.59003 Boehringer Ingelheim Investigational Site
Plovdiv
1275.1.59006 Boehringer Ingelheim Investigational Site
Rousse
1275.1.59004 Boehringer Ingelheim Investigational Site
Sofia

Other trials in Bulgaria

Denmark3 sites

1275.1.45004 Boehringer Ingelheim Investigational Site
Aalborg
1275.1.45003 Boehringer Ingelheim Investigational Site
Aarhus C
1275.1.45002 Boehringer Ingelheim Investigational Site
København NV

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Hungary3 sites

1275.1.36002 Boehringer Ingelheim Investigational Site
Budapest
1275.1.36003 Boehringer Ingelheim Investigational Site
Budapest
1275.1.36001 Boehringer Ingelheim Investigational Site
Gyöngyös

Other trials in Hungary

Sweden3 sites

1275.1.46003 Boehringer Ingelheim Investigational Site
Järfälla
1275.1.46004 Boehringer Ingelheim Investigational Site
Rättvik
1275.1.46002 Boehringer Ingelheim Investigational Site
Skene

Other trials in Sweden

Australia2 sites

1275.1.61002 Boehringer Ingelheim Investigational Site
East Ringwood, Victoria
1275.1.61003 Boehringer Ingelheim Investigational Site
Wollongong, New South Wales

Other trials in Australia

Malaysia2 sites

1275.1.60001 Boehringer Ingelheim Investigational Site
Kedah
1275.1.60002 Boehringer Ingelheim Investigational Site
Perak

Other trials in Malaysia

About this study

Official title: A Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Individual Components (BI 10773 25 mg, BI 10773 10 mg, and Linagliptin 5 mg) for 52 Weeks in Treatment naïve and Metformin Treated Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control

Conditions: Diabetes Mellitus, Type 2
Being tested: high dose FDC, BI 10773 high dose, high dose FDC placebo, low dose FDC placebo, high dose BI 10773 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.

high dose FDCDrug
once daily
BI 10773 high doseDrug
once daily
high dose FDC placeboDrug
once daily
low dose FDC placeboDrug
once daily
high dose FDC placeboDrug
once daily
high dose FDC placeboDrug
once daily
low dose FDC placeboDrug
once daily
low dose FDC placeboDrug
once daily
high dose BI 10773 placeboDrug
once daily
low dose FDCDrug
once daily
high dose FDC placeboDrug
once daily
BI 10773 low doseDrug
low dose once daily
high dose BI 10773 placeboDrug
once daily
high dose BI 10773 placeboDrug
once daily
linagliptinDrug
once daily
low dose FDC placeboDrug
once daily
linagliptin placeboDrug
once daily
BI 10773 low dose placeboDrug
once daily
linagliptin placeboDrug
once daily
low dose BI 10773 placeboDrug
once daily
linagliptin placeboDrug
once daily
high dose BI 10773 placeboDrug
once daily
BI 10773 low dose placeboDrug
once daily
low dose BI 10773 placeboDrug
once daily
linagliptin placeboDrug
once daily

Study groups in NCT01422876
Study group	Role	What they receive
BI 10773/linagliptin FDC (high dose)	Experimental	Patients receive BI 10773/linagliptin FDC (high dose) once daily Receives: Drug: high dose FDC; Drug: low dose FDC placebo; Drug: high dose BI 10773 placebo; Drug: BI 10773 low dose placebo; Drug: linagliptin placebo
BI 10773/linagliptin FDC (low dose)	Experimental	Patients receive BI 10773/linagliptin FDC (low dose) once daily Receives: Drug: high dose FDC placebo; Drug: low dose FDC; Drug: high dose BI 10773 placebo; Drug: BI 10773 low dose placebo; Drug: linagliptin placebo
BI 10773 (high dose)	Active comparator	Patients receive BI 10773 (high dose) once daily Receives: Drug: BI 10773 high dose; Drug: high dose FDC placebo; Drug: low dose FDC placebo; Drug: low dose BI 10773 placebo; Drug: linagliptin placebo
BI 10773 (low dose)	Active comparator	Patients receive BI 10773 (low dose) once daily Receives: Drug: high dose FDC placebo; Drug: low dose FDC placebo; Drug: high dose BI 10773 placebo; Drug: BI 10773 low dose; Drug: linagliptin placebo
Linagliptin	Active comparator	Patients receive linagliptin once daily Receives: Drug: low dose FDC placebo; Drug: high dose FDC placebo; Drug: linagliptin; Drug: high dose BI 10773 placebo; Drug: low dose BI 10773 placebo

What is being measured

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

Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients
Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.
Measured: Baseline and 24 weeks
Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients
Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.
Measured: Baseline and 24 weeks

Secondary outcomes (6)

Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients
Change from baseline in fasting plasma glucose at week 24 for Metformin Background patients.
Measured: Baseline and 24 Weeks
Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients
Change from baseline in fasting plasma glucose at week 24 for Treatment Naive patients.
Measured: Baseline and 24 Weeks
Change From Baseline in Body Weight for Metformin Background Patients
Change from baseline in body weight for Metformin Background patients.
Measured: Baseline and 24 Weeks
Change From Baseline in Body Weight for Treatment Naive Patients
Change from baseline in body weight for Treatment Naive patients.
Measured: Baseline and 24 Weeks
Occurrence of Treat to Target Efficacy Response for Metformin Background Patients
Occurrence of the treat-to-target efficacy response for Metformin Background patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.
Measured: 24 Weeks
Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients
Occurrence of the treat-to-target efficacy response for Treatment Naive patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.
Measured: 24 Weeks

Timeline

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

Aug 2011Sep 2013

First posted25 Aug 2011 (estimated)
Study startAug 2011
Primary completionSep 2013
Study completionSep 2013

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 (3)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: 1,405 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01422876
Sponsor's protocol ID: 1275.1
Other IDs: 2011-000383-10
Status last verified: Mar 2015
First submitted: 23 Aug 2011
Last updated: 2 Apr 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

DeFronzo RA, Lee C, Kohler S. Safety and Tolerability of Combinations of Empagliflozin and Linagliptin in Patients with Type 2 Diabetes: Pooled Data from Two Randomized Controlled Trials. Adv Ther. 2018 Jul;35(7):1009-1022. doi: 10.1007/s12325-018-0724-y. Epub 2018 Jun 15.
PubMed 29949041
Lewin A, DeFronzo RA, Patel S, Liu D, Kaste R, Woerle HJ, Broedl UC. Initial combination of empagliflozin and linagliptin in subjects with type 2 diabetes. Diabetes Care. 2015 Mar;38(3):394-402. doi: 10.2337/dc14-2365. Epub 2015 Jan 29.
PubMed 25633662
DeFronzo RA, Lewin A, Patel S, Liu D, Kaste R, Woerle HJ, Broedl UC. Combination of empagliflozin and linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin. Diabetes Care. 2015 Mar;38(3):384-93. doi: 10.2337/dc14-2364. Epub 2015 Jan 12.
PubMed 25583754

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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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2015. 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 Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Individual Components (BI 10773 25 mg, BI 10773 10 mg, and Linagliptin 5 mg) for 52 Weeks in Treatment naïve and Metformin Treated Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
ClinicalTrials.gov ID: NCT01422876
Acronym / sponsor ID: 1275.1
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,405 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Aug 2011
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 25 Aug 2011 (estimated)
Results: Posted 2 Apr 2015

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: 5

Arm	Type	Receives
BI 10773/linagliptin FDC (high dose)	Experimental	Drug: high dose FDC, Drug: low dose FDC placebo, Drug: high dose BI 10773 placebo, Drug: BI 10773 low dose placebo, Drug: linagliptin placeboPatients receive BI 10773/linagliptin FDC (high dose) once daily
BI 10773/linagliptin FDC (low dose)	Experimental	Drug: high dose FDC placebo, Drug: low dose FDC, Drug: high dose BI 10773 placebo, Drug: BI 10773 low dose placebo, Drug: linagliptin placeboPatients receive BI 10773/linagliptin FDC (low dose) once daily
BI 10773 (high dose)	Active comparator	Drug: BI 10773 high dose, Drug: high dose FDC placebo, Drug: low dose FDC placebo, Drug: low dose BI 10773 placebo, Drug: linagliptin placeboPatients receive BI 10773 (high dose) once daily
BI 10773 (low dose)	Active comparator	Drug: high dose FDC placebo, Drug: low dose FDC placebo, Drug: high dose BI 10773 placebo, Drug: BI 10773 low dose, Drug: linagliptin placeboPatients receive BI 10773 (low dose) once daily
Linagliptin	Active comparator	Drug: low dose FDC placebo, Drug: high dose FDC placebo, Drug: linagliptin, Drug: high dose BI 10773 placebo, Drug: low dose BI 10773 placeboPatients receive linagliptin once daily

Who may qualify

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

Key inclusion criteria (3 listed)

Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients on diet and exercise regimen who are drug-naïve (defined as absence of any oral antidiabetic therapy, glucagon like peptide-1 analog or insulin for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
Glycosylated hemoglobin (HbA1c) = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3 mmol/mol) at Visit 1 (screening)

Key exclusion criteria (3 listed)

Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
Any other antidiabetic drug within 12 weeks prior to randomization (except metformin background therapy as defined via inclusion criterion 2)
Acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction and unstable angina pectoris), stroke or (transient ischemic attack) TIA 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
high dose FDConce daily	Drug	BI 10773/linagliptin FDC (high dose)
BI 10773 high doseonce daily	Drug	BI 10773 (high dose)
high dose FDC placeboonce daily	Drug	BI 10773 (low dose)
low dose FDC placeboonce daily	Drug	BI 10773/linagliptin FDC (high dose)
high dose FDC placeboonce daily	Drug	BI 10773/linagliptin FDC (low dose)
high dose FDC placeboonce daily	Drug	BI 10773 (high dose)
low dose FDC placeboonce daily	Drug	BI 10773 (low dose)
low dose FDC placeboonce daily	Drug	Linagliptin
high dose BI 10773 placeboonce daily	Drug	BI 10773 (low dose)
low dose FDConce daily	Drug	BI 10773/linagliptin FDC (low dose)
high dose FDC placeboonce daily	Drug	Linagliptin
BI 10773 low doselow dose once daily	Drug	BI 10773 (low dose)
high dose BI 10773 placeboonce daily	Drug	BI 10773/linagliptin FDC (high dose)
high dose BI 10773 placeboonce daily	Drug	BI 10773/linagliptin FDC (low dose)
linagliptinonce daily	Drug	Linagliptin
low dose FDC placeboonce daily	Drug	BI 10773 (high dose)
linagliptin placeboonce daily	Drug	BI 10773 (low dose)
BI 10773 low dose placeboonce daily	Drug	BI 10773/linagliptin FDC (high dose)
linagliptin placeboonce daily	Drug	BI 10773/linagliptin FDC (high dose)
low dose BI 10773 placeboonce daily	Drug	BI 10773 (high dose)
linagliptin placeboonce daily	Drug	BI 10773 (high dose)
high dose BI 10773 placeboonce daily	Drug	Linagliptin
BI 10773 low dose placeboonce daily	Drug	BI 10773/linagliptin FDC (low dose)
low dose BI 10773 placeboonce daily	Drug	Linagliptin
linagliptin placeboonce daily	Drug	BI 10773/linagliptin FDC (low dose)

Primary outcome

Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients
Time frame: Baseline and 24 weeks
Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients
Time frame: Baseline and 24 weeks
Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.

6 secondary outcomes

Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients
Time frame: Baseline and 24 Weeks
Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients
Time frame: Baseline and 24 Weeks
Change From Baseline in Body Weight for Metformin Background Patients
Time frame: Baseline and 24 Weeks
Change From Baseline in Body Weight for Treatment Naive Patients
Time frame: Baseline and 24 Weeks
Occurrence of Treat to Target Efficacy Response for Metformin Background Patients
Time frame: 24 Weeks
Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients
Time frame: 24 Weeks

Results and safety

Results posted to the registry on 2 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg	137	131
Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg	136	133
Metformin Background: Empagliflozin 25 mg	141	136
Metformin Background: Empagliflozin 10 mg	140	132
Metformin Background: Linagliptin 5 mg	132	125
Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg	137	131
Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg	136	130
Treatment Naive: Empagliflozin 25 mg	135	128
Treatment Naive: Empagliflozin 10 mg	134	128
Treatment Naive: Linagliptin 5 mg	135	125

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients

Time frame: Baseline and 24 weeks. Least squares mean (Standard Error). Unit: % change from baseline

Measure	Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg n = 134	Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg n = 135	Metformin Background: Empagliflozin 25 mg n = 140	Metformin Background: Empagliflozin 10 mg n = 137	Metformin Background: Linagliptin 5 mg n = 128
Value	-1.19 (0.06)	-1.08 (0.06)	-0.62 (0.06)	-0.66 (0.06)	-0.70 (0.06)

Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg vs Metformin Background: Empagliflozin 25 mg: Mean Difference (Net): -0.58 (95% CI -0.75 to -0.41), p <0.0001, ANCOVA
Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg vs Metformin Background: Linagliptin 5 mg: Mean Difference (Net): -0.50 (95% CI -0.67 to -0.32), p <0.0001, ANCOVA
Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg vs Metformin Background: Empagliflozin 10 mg: Mean Difference (Net): -0.42 (95% CI -0.59 to -0.25), p <0.0001, ANCOVA

Population analysed: Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all Metformin Background patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients

Time frame: Baseline and 24 weeks. Least squares mean (Standard Error). Unit: % change from baseline

Measure	Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg n = 134	Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg n = 135	Treatment Naive: Empagliflozin 25 mg n = 133	Treatment Naive: Empagliflozin 10 mg n = 132	Treatment Naive: Linagliptin 5 mg n = 133
Value	-1.08 (0.07)	-1.24 (0.07)	-0.95 (0.07)	-0.83 (0.07)	-0.67 (0.07)

Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg vs Treatment Naive: Empagliflozin 25 mg: Mean Difference (Net): -0.14 (95% CI -0.33 to 0.06), p = 0.1785, ANCOVA
Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg vs Treatment Naive: Empagliflozin 10 mg: Mean Difference (Net): -0.41 (95% CI -0.61 to -0.21), p <0.0001, ANCOVA
Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg vs Treatment Naive: Linagliptin 5 mg: Mean Difference (Net): -0.41 (95% CI -0.61 to -0.22), p <0.0001, Cochran-Mantel-Haenszel

Population analysed: Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all treatment naive patients randomised to and treated who had a baseline and at least 1 on treatment HbA1c value.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first trial medication intake until 7 days after last drug intake during the 52-week study period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empagliflozin 25 mg/Linagliptin 5 mg	12 of 273 (4.4%)	80 of 273 (29.3%)	Not reported
Empagliflozin 10 mg/Linagliptin 5 mg	16 of 272 (5.9%)	86 of 272 (31.6%)	Not reported
Empagliflozin 25 mg	19 of 276 (6.9%)	70 of 276 (25.4%)	Not reported
Empagliflozin 10 mg	16 of 275 (5.8%)	83 of 275 (30.2%)	Not reported
Linagliptin 5 mg	10 of 267 (3.7%)	94 of 267 (35.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29949041DeFronzo RA, Lee C, Kohler S. Safety and Tolerability of Combinations of Empagliflozin and Linagliptin in Patients with Type 2 Diabetes: Pooled Data from Two Randomized Controlled Trials. Adv Ther. 2018 Jul;35(7):1009-1022. doi: 10.1007/s12325-018-0724-y. Epub 2018 Jun 15.
Derived from this study: PubMed 25633662Lewin A, DeFronzo RA, Patel S, Liu D, Kaste R, Woerle HJ, Broedl UC. Initial combination of empagliflozin and linagliptin in subjects with type 2 diabetes. Diabetes Care. 2015 Mar;38(3):394-402. doi: 10.2337/dc14-2365. Epub 2015 Jan 29.
Derived from this study: PubMed 25583754DeFronzo RA, Lewin A, Patel S, Liu D, Kaste R, Woerle HJ, Broedl UC. Combination of empagliflozin and linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin. Diabetes Care. 2015 Mar;38(3):384-93. doi: 10.2337/dc14-2364. Epub 2015 Jan 12.
Boehringer Ingelheim Global Clinical Trials WebsiteLink provided by the sponsor.

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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

211 sites in 22 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing high dose FDC and BI 10773 high dose in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 211 sites in 22 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 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 211 sites in United States, Romania, Canada, Taiwan, Lebanon and 17 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 2 Apr 2015). 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 in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients (time frame: Baseline and 24 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 NCT01422876, which also lists 3 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 2 Apr 2015.