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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,405

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

September 30, 2013

Study Completion Date

September 30, 2013

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

high dose FDC

once daily

DRUG

BI 10773 high dose

once daily

DRUG

high dose FDC placebo

once daily

DRUG

low dose FDC placebo

once daily

DRUG

high dose FDC placebo

once daily

DRUG

high dose FDC placebo

once daily

DRUG

low dose FDC placebo

once daily

DRUG

low dose FDC placebo

once daily

DRUG

high dose BI 10773 placebo

once daily

DRUG

low dose FDC

once daily

DRUG

high dose FDC placebo

once daily

DRUG

BI 10773 low dose

low dose once daily

DRUG

high dose BI 10773 placebo

once daily

DRUG

high dose BI 10773 placebo

once daily

DRUG

linagliptin

once daily

DRUG

low dose FDC placebo

once daily

DRUG

linagliptin placebo

once daily

DRUG

BI 10773 low dose placebo

once daily

DRUG

linagliptin placebo

once daily

DRUG

low dose BI 10773 placebo

once daily

DRUG

linagliptin placebo

once daily

DRUG

high dose BI 10773 placebo

once daily

DRUG

BI 10773 low dose placebo

once daily

DRUG

low dose BI 10773 placebo

once daily

DRUG

linagliptin placebo

once daily

Trial Locations (211)

Unknown

1275.1.01103 Boehringer Ingelheim Investigational Site, Birmingham

1275.1.01107 Boehringer Ingelheim Investigational Site, Foley

1275.1.01043 Boehringer Ingelheim Investigational Site, Mobile

1275.1.01066 Boehringer Ingelheim Investigational Site, Mobile

1275.1.01047 Boehringer Ingelheim Investigational Site, Pell City

1275.1.01089 Boehringer Ingelheim Investigational Site, Mesa

1275.1.01064 Boehringer Ingelheim Investigational Site, Tempe

1275.1.01028 Boehringer Ingelheim Investigational Site, Little Rock

1275.1.01086 Boehringer Ingelheim Investigational Site, Cerritos

1275.1.01067 Boehringer Ingelheim Investigational Site, Chula Vista

1275.1.01109 Boehringer Ingelheim Investigational Site, Encino

1275.1.01012 Boehringer Ingelheim Investigational Site, Fresno

1275.1.01050 Boehringer Ingelheim Investigational Site, Harbor City

1275.1.01056 Boehringer Ingelheim Investigational Site, Huntington Park

1275.1.01021 Boehringer Ingelheim Investigational Site, Long Beach

1275.1.01024 Boehringer Ingelheim Investigational Site, Los Angeles

1275.1.01112 Boehringer Ingelheim Investigational Site, Los Angeles

1275.1.01083 Boehringer Ingelheim Investigational Site, Oceanside

1275.1.01071 Boehringer Ingelheim Investigational Site, San Dimas

1275.1.01044 Boehringer Ingelheim Investigational Site, Tustin

1275.1.01078 Boehringer Ingelheim Investigational Site, Colorado Springs

1275.1.01124 Boehringer Ingelheim Investigational Site, Colorado Springs

1275.1.01010 Boehringer Ingelheim Investigational Site, Denver

1275.1.01048 Boehringer Ingelheim Investigational Site, Denver

1275.1.01073 Boehringer Ingelheim Investigational Site, Gainesville

1275.1.01063 Boehringer Ingelheim Investigational Site, Hialeah

1275.1.01077 Boehringer Ingelheim Investigational Site, Hialeah

1275.1.01090 Boehringer Ingelheim Investigational Site, Inverness

1275.1.01054 Boehringer Ingelheim Investigational Site, Jacksonville

1275.1.01092 Boehringer Ingelheim Investigational Site, Maitland

1275.1.01065 Boehringer Ingelheim Investigational Site, Miami

1275.1.01110 Boehringer Ingelheim Investigational Site, Miami

1275.1.01040 Boehringer Ingelheim Investigational Site, Miami Beach

1275.1.01025 Boehringer Ingelheim Investigational Site, Miami Lakes

1275.1.01094 Boehringer Ingelheim Investigational Site, Orlando

1275.1.01068 Boehringer Ingelheim Investigational Site, Ormond Beach

1275.1.01051 Boehringer Ingelheim Investigational Site, Pembroke Pines

1275.1.01079 Boehringer Ingelheim Investigational Site, Port Orange

1275.1.01117 Boehringer Ingelheim Investigational Site, St. Petersburg

1275.1.01039 Boehringer Ingelheim Investigational Site, Atlanta

1275.1.01007 Boehringer Ingelheim Investigational Site, Marietta

1275.1.01111 Boehringer Ingelheim Investigational Site, Norcross

1275.1.01076 Boehringer Ingelheim Investigational Site, Savannah

1275.1.01100 Boehringer Ingelheim Investigational Site, Addison

1275.1.01042 Boehringer Ingelheim Investigational Site, Des Moines

1275.1.01059 Boehringer Ingelheim Investigational Site, Paducah

1275.1.01003 Boehringer Ingelheim Investigational Site, Shreveport

1275.1.01125 Boehringer Ingelheim Investigational Site, Hyattsville

1275.1.01081 Boehringer Ingelheim Investigational Site, Boston

1275.1.01085 Boehringer Ingelheim Investigational Site, Rochester

1275.1.01035 Boehringer Ingelheim Investigational Site, Southfield

1275.1.01023 Boehringer Ingelheim Investigational Site, St Louis

1275.1.01027 Boehringer Ingelheim Investigational Site, St Louis

1275.1.01033 Boehringer Ingelheim Investigational Site, Great Falls

1275.1.01099 Boehringer Ingelheim Investigational Site, Henderson

1275.1.01101 Boehringer Ingelheim Investigational Site, Las Vegas

1275.1.01114 Boehringer Ingelheim Investigational Site, Las Vegas

1275.1.01123 Boehringer Ingelheim Investigational Site, Las Vegas

1275.1.01013 Boehringer Ingelheim Investigational Site, Elizabeth

1275.1.01057 Boehringer Ingelheim Investigational Site, Albuquerque

1275.1.01002 Boehringer Ingelheim Investigational Site, Binghamton

1275.1.01020 Boehringer Ingelheim Investigational Site, Endwell

1275.1.01095 Boehringer Ingelheim Investigational Site, Flushing

1275.1.01062 Boehringer Ingelheim Investigational Site, Glens Falls

1275.1.01006 Boehringer Ingelheim Investigational Site, New York

1275.1.01011 Boehringer Ingelheim Investigational Site, Asheboro

1275.1.01052 Boehringer Ingelheim Investigational Site, Burlington

1275.1.01045 Boehringer Ingelheim Investigational Site, Charlotte

1275.1.01001 Boehringer Ingelheim Investigational Site, Akron

1275.1.01032 Boehringer Ingelheim Investigational Site, Cincinnati

1275.1.01061 Boehringer Ingelheim Investigational Site, Cincinnati

1275.1.01116 Boehringer Ingelheim Investigational Site, Cincinnati

1275.1.01016 Boehringer Ingelheim Investigational Site, Columbus

1275.1.01102 Boehringer Ingelheim Investigational Site, Columbus

1275.1.01017 Boehringer Ingelheim Investigational Site, Dayton

1275.1.01036 Boehringer Ingelheim Investigational Site, Dayton

1275.1.01030 Boehringer Ingelheim Investigational Site, Delaware

1275.1.01055 Boehringer Ingelheim Investigational Site, Groveport

1275.1.01075 Boehringer Ingelheim Investigational Site, Wadsworth

1275.1.01034 Boehringer Ingelheim Investigational Site, Norman

1275.1.01082 Boehringer Ingelheim Investigational Site, Corvallis

1275.1.01084 Boehringer Ingelheim Investigational Site, Altoona

1275.1.01038 Boehringer Ingelheim Investigational Site, Fleetwood

1275.1.01019 Boehringer Ingelheim Investigational Site, Pittsburgh

1275.1.01072 Boehringer Ingelheim Investigational Site, Scottdale

1275.1.01088 Boehringer Ingelheim Investigational Site, Tipton

1275.1.01014 Boehringer Ingelheim Investigational Site, Uniontown

1275.1.01060 Boehringer Ingelheim Investigational Site, Uniontown

1275.1.01093 Boehringer Ingelheim Investigational Site, Charleston

1275.1.01122 Boehringer Ingelheim Investigational Site, Florence

1275.1.01005 Boehringer Ingelheim Investigational Site, Hodges

1275.1.01015 Boehringer Ingelheim Investigational Site, Brentwood

1275.1.01031 Boehringer Ingelheim Investigational Site, Chattanooga

1275.1.01121 Boehringer Ingelheim Investigational Site, Memphis

1275.1.01069 Boehringer Ingelheim Investigational Site, Spring Hill

1275.1.01049 Boehringer Ingelheim Investigational Site, Austin

1275.1.01080 Boehringer Ingelheim Investigational Site, Austin

1275.1.01029 Boehringer Ingelheim Investigational Site, Houston

1275.1.01053 Boehringer Ingelheim Investigational Site, Houston

1275.1.01106 Boehringer Ingelheim Investigational Site, Houston

1275.1.01018 Boehringer Ingelheim Investigational Site, Pearland

1275.1.01096 Boehringer Ingelheim Investigational Site, San Antonio

1275.1.01113 Boehringer Ingelheim Investigational Site, San Antonio

1275.1.01120 Boehringer Ingelheim Investigational Site, San Antonio

1275.1.01105 Boehringer Ingelheim Investigational Site, Spring

1275.1.01037 Boehringer Ingelheim Investigational Site, Waco

1275.1.01008 Boehringer Ingelheim Investigational Site, Bountiful

1275.1.01022 Boehringer Ingelheim Investigational Site, West Jordan

1275.1.01091 Boehringer Ingelheim Investigational Site, South Chesterfield

1275.1.01118 Boehringer Ingelheim Investigational Site, Selah

1275.1.01087 Boehringer Ingelheim Investigational Site, Shoreline

1275.1.01119 Boehringer Ingelheim Investigational Site, Spokane

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

1275.1.61003 Boehringer Ingelheim Investigational Site, Wollongong

1275.1.61002 Boehringer Ingelheim Investigational Site, East Ringwood

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

1275.1.59003 Boehringer Ingelheim Investigational Site, Plovdiv

1275.1.59006 Boehringer Ingelheim Investigational Site, Rousse

1275.1.59004 Boehringer Ingelheim Investigational Site, Sofia

1275.1.20008 Boehringer Ingelheim Investigational Site, Bathurst

1275.1.20007 Boehringer Ingelheim Investigational Site, Bay Roberts

1275.1.20006 Boehringer Ingelheim Investigational Site, Mount Pearl

1275.1.20004 Boehringer Ingelheim Investigational Site, St. John's

1275.1.20001 Boehringer Ingelheim Investigational Site, Brampton

1275.1.20005 Boehringer Ingelheim Investigational Site, Toronto

1275.1.20003 Boehringer Ingelheim Investigational Site, Drummondville

1275.1.20002 Boehringer Ingelheim Investigational Site, Pointe-Claire

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

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

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

1275.1.36002 Boehringer Ingelheim Investigational Site, Budapest

1275.1.36003 Boehringer Ingelheim Investigational Site, Budapest

1275.1.36001 Boehringer Ingelheim Investigational Site, Gyöngyös

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

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

1275.1.60001 Boehringer Ingelheim Investigational Site, Kedah

1275.1.60002 Boehringer Ingelheim Investigational Site, Perak

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

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

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

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

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

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

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

1275.1.46003 Boehringer Ingelheim Investigational Site, Järfälla

1275.1.46004 Boehringer Ingelheim Investigational Site, Rättvik

1275.1.46002 Boehringer Ingelheim Investigational Site, Skene

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 City

1275.1.88002 Far Eastern Memorial Hospital, Taipei

1275.1.88003 Taipei Chang Gung Memorial Hospital, Taipei

Sponsors
All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

Boehringer Ingelheim

INDUSTRY