Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes

PHASE3CompletedINTERVENTIONAL
Enrollment

1,413

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

November 30, 2014

Study Completion Date

December 31, 2014

Conditions
Diabetes Mellitus, Type 2Hyperglycemia
Interventions
DRUG

Metformin 500 mg bid

Metformin 500 mg twice daily

DRUG

Metformin 1000 mg bid

Metformin 1000 mg twice daily

DRUG

Empagliflozin low dose qd

Empagliflozin low dose once daily

DRUG

Empagliflozin high dose qd

Empagliflozin high dose once daily

DRUG

Empagliflozin low dose bid

Empagliflozin low dose split twice daily

DRUG

Metformin 500 mg bid

Metformin 500 mg twice daily

DRUG

Empagliflozin high dose bid

Empagliflozin high dose split twice daily

DRUG

Empagliflozin low dose bid

Empagliflozin low dose split twice daily

DRUG

Metformin 1000 mg bid

Metformin 1000 mg twice daily

DRUG

Metformin 500 mg bid

Metformin 500 mg twice daily

DRUG

Metformin 1000 mg bid

Metformin 1000 mg twice daily

DRUG

Empagliflozin high dose bid

Empagliflozin high dose split twice daily

DRUG

Metformin 1000 mg bid

Metformin 1000 mg twice daily

DRUG

Empagliflozin high dose bid

Empagliflozin high dose split twice daily

Trial Locations (190)

Unknown

1276.1.10014 Boehringer Ingelheim Investigational Site, Birmingham

1276.1.10019 Boehringer Ingelheim Investigational Site, Birmingham

1276.1.10044 Boehringer Ingelheim Investigational Site, Manley Hot Springs

1276.1.10010 Boehringer Ingelheim Investigational Site, Glendale

1276.1.10035 Boehringer Ingelheim Investigational Site, Searcy

1276.1.10046 Boehringer Ingelheim Investigational Site, Chula Vista

1276.1.10006 Boehringer Ingelheim Investigational Site, Huntington Beach

1276.1.10043 Boehringer Ingelheim Investigational Site, La Mesa

1276.1.10009 Boehringer Ingelheim Investigational Site, Los Angeles

1276.1.10040 Boehringer Ingelheim Investigational Site, Los Angeles

1276.1.10045 Boehringer Ingelheim Investigational Site, Oceanside

1276.1.10042 Boehringer Ingelheim Investigational Site, Colorado Springs

1276.1.10001 Boehringer Ingelheim Investigational Site, Denver

1276.1.10003 Boehringer Ingelheim Investigational Site, Northglenn

1276.1.10026 Boehringer Ingelheim Investigational Site, Fort Lauderdale

1276.1.10024 Boehringer Ingelheim Investigational Site, Oldsmar

1276.1.10027 Boehringer Ingelheim Investigational Site, Port Orange

1276.1.10023 Boehringer Ingelheim Investigational Site, Marietta

1276.1.10034 Boehringer Ingelheim Investigational Site, Evansville

1276.1.10032 Boehringer Ingelheim Investigational Site, Fall River

1276.1.10036 Boehringer Ingelheim Investigational Site, Bridgman

1276.1.10037 Boehringer Ingelheim Investigational Site, Hazelwood

1276.1.10007 Boehringer Ingelheim Investigational Site, Las Vegas

1276.1.10015 Boehringer Ingelheim Investigational Site, Union

1276.1.10033 Boehringer Ingelheim Investigational Site, Asheboro

1276.1.10022 Boehringer Ingelheim Investigational Site, Burlington

1276.1.10002 Boehringer Ingelheim Investigational Site, Lenoir

1276.1.10005 Boehringer Ingelheim Investigational Site, Cincinnati

1276.1.10011 Boehringer Ingelheim Investigational Site, Gallipolis

1276.1.10030 Boehringer Ingelheim Investigational Site, Columbia

1276.1.10008 Boehringer Ingelheim Investigational Site, Greer

1276.1.10013 Boehringer Ingelheim Investigational Site, Hodges

1276.1.10017 Boehringer Ingelheim Investigational Site, Humboldt

1276.1.10018 Boehringer Ingelheim Investigational Site, Houston

1276.1.10025 Boehringer Ingelheim Investigational Site, Houston

1276.1.10028 Boehringer Ingelheim Investigational Site, Houston

1276.1.10016 Boehringer Ingelheim Investigational Site, Kingwood

1276.1.10021 Boehringer Ingelheim Investigational Site, San Antonio

1276.1.10041 Boehringer Ingelheim Investigational Site, San Antonio

1276.1.10004 Boehringer Ingelheim Investigational Site, Manassas

1276.1.10012 Boehringer Ingelheim Investigational Site, Wenatchee

1276.1.55008 Boehringer Ingelheim Investigational Site, Belém

1276.1.55003 Boehringer Ingelheim Investigational Site, Brasília

1276.1.55006 Boehringer Ingelheim Investigational Site, Fortaleza

1276.1.55007 Boehringer Ingelheim Investigational Site, Fortaleza

1276.1.55009 Boehringer Ingelheim Investigational Site, Fortaleza

1276.1.55004 Boehringer Ingelheim Investigational Site, Goiânia

1276.1.55002 Boehringer Ingelheim Investigational Site, Porto Alegre

1276.1.55001 Boehringer Ingelheim Investigational Site, São Paulo

1276.1.20003 Boehringer Ingelheim Investigational Site, Coquitlam

1276.1.20012 Boehringer Ingelheim Investigational Site, Coquitlam

1276.1.20008 Boehringer Ingelheim Investigational Site, Victoria

1276.1.20004 Boehringer Ingelheim Investigational Site, Antigonish

1276.1.20005 Boehringer Ingelheim Investigational Site, Hawkesbury

1276.1.20013 Boehringer Ingelheim Investigational Site, Sarnia

1276.1.20010 Boehringer Ingelheim Investigational Site, Strathroy

1276.1.20006 Boehringer Ingelheim Investigational Site, Thornhill

1276.1.20007 Boehringer Ingelheim Investigational Site, Mirabel

1276.1.20002 Boehringer Ingelheim Investigational Site, Québec

1276.1.20001 Boehringer Ingelheim Investigational Site, Saskatoon

1276.1.42002 Boehringer Ingelheim Investigational Site, Benátky nad Jizerou

1276.1.42008 Boehringer Ingelheim Investigational Site, Olomouc

1276.1.42007 Boehringer Ingelheim Investigational Site, Ostrava

1276.1.42009 Boehringer Ingelheim Investigational Site, Pilsen

1276.1.42003 Boehringer Ingelheim Investigational Site, Prague

1276.1.42004 Boehringer Ingelheim Investigational Site, Prague

1276.1.42010 Boehringer Ingelheim Investigational Site, Prague

1276.1.95001 Boehringer Ingelheim Investigational Site, Abbasia Cairo, Egypt

1276.1.95003 Boehringer Ingelheim Investigational Site, Al Manial, Cairo, Egypt

1276.1.95004 Boehringer Ingelheim Investigational Site, Alexandria

1276.1.95002 Boehringer Ingelheim Investigational Site, El Darasa Cairo Egypt

1276.1.33004 Boehringer Ingelheim Investigational Site, Behren-lès-Forbach

1276.1.33012 Boehringer Ingelheim Investigational Site, Bersée

1276.1.33005 Boehringer Ingelheim Investigational Site, Cournonterral

1276.1.33007 Boehringer Ingelheim Investigational Site, Hautmont

1276.1.33013 Boehringer Ingelheim Investigational Site, Paris

1276.1.33001 Boehringer Ingelheim Investigational Site, Poitiers

1276.1.33006 Boehringer Ingelheim Investigational Site, Saint-Génis-des-Fontaines

1276.1.33003 Boehringer Ingelheim Investigational Site, Savonnières

1276.1.33002 Boehringer Ingelheim Investigational Site, Thouars

1276.1.33011 Boehringer Ingelheim Investigational Site, Thun-Saint-Amand

1276.1.33010 Boehringer Ingelheim Investigational Site, Tours

1276.1.33009 Boehringer Ingelheim Investigational Site, Vandome

1276.1.33008 Boehringer Ingelheim Investigational Site, Vieux-Condé

1276.1.49005 Boehringer Ingelheim Investigational Site, Berlin

1276.1.49008 Boehringer Ingelheim Investigational Site, Celle

1276.1.49006 Boehringer Ingelheim Investigational Site, Dortmund

1276.1.49011 Boehringer Ingelheim Investigational Site, Dresden

1276.1.49003 Boehringer Ingelheim Investigational Site, Essen

1276.1.49007 Boehringer Ingelheim Investigational Site, Ingelheim

1276.1.49014 Boehringer Ingelheim Investigational Site, Neuwied

1276.1.49004 Boehringer Ingelheim Investigational Site, Offenbach

1276.1.49002 Boehringer Ingelheim Investigational Site, Stuhr-Brinkum

1276.1.49012 Boehringer Ingelheim Investigational Site, Teuchern

1276.1.50002 Boehringer Ingelheim Investigational Site, Barbena Santa Rosa

1276.1.50003 Boehringer Ingelheim Investigational Site, Guatemala City

1276.1.50005 Boehringer Ingelheim Investigational Site, Guatemala City

1276.1.50006 Boehringer Ingelheim Investigational Site, Guatemala City

1276.1.50001 Boehringer Ingelheim Investigational Site, Quetzaltenango

1276.1.96001 Boehringer Ingelheim Investigational Site, Beirut

1276.1.96002 Boehringer Ingelheim Investigational Site, El Chouf

1276.1.96003 Boehringer Ingelheim Investigational Site, Saida

1276.1.96004 Boehringer Ingelheim Investigational Site, Saida

1276.1.60002 Boehringer Ingelheim Investigational Site, Ipoh, Perak

1276.1.60001 Boehringer Ingelheim Investigational Site, Johor Bahru

1276.1.60003 Boehringer Ingelheim Investigational Site, Kubang Kerian

1276.1.52004 Boehringer Ingelheim Investigational Site, Aguascalientes

1276.1.52007 Boehringer Ingelheim Investigational Site, Aguascalientes

1276.1.52003 Boehringer Ingelheim Investigational Site, Guadalajara

1276.1.52002 Boehringer Ingelheim Investigational Site, Mexico City

1276.1.52001 Boehringer Ingelheim Investigational Site, Monterrey

1276.1.52006 Boehringer Ingelheim Investigational Site, San Lucas Tepetlcalco

1276.1.52005 Boehringer Ingelheim Investigational Site, Zapopan

1276.1.51001 Boehringer Ingelheim Investigational Site, Lima

1276.1.51002 Boehringer Ingelheim Investigational Site, Lima

1276.1.51003 Boehringer Ingelheim Investigational Site, Lima

1276.1.51004 Boehringer Ingelheim Investigational Site, Lima

1276.1.51005 Boehringer Ingelheim Investigational Site, Lima

1276.1.63009 Boehringer Ingelheim Investigational Site, Cebu City, Cebu

1276.1.63002 Boehringer Ingelheim Investigational Site, Cebu City, Philippines

1276.1.63004 Boehringer Ingelheim Investigational Site, Davao City

1276.1.63003 Boehringer Ingelheim Investigational Site, Iloilo City

1276.1.63006 Boehringer Ingelheim Investigational Site, Manila

1276.1.63001 Boehringer Ingelheim Investigational Site, Marikina City

1276.1.63005 Boehringer Ingelheim Investigational Site, Maybunga, Pasig City

1276.1.63007 Boehringer Ingelheim Investigational Site, San Juan City

1276.1.63008 Boehringer Ingelheim Investigational Site, Tarlac City

1276.1.70012 Boehringer Ingelheim Investigational Site, Barnaul

1276.1.70011 Boehringer Ingelheim Investigational Site, Kemerovo

1276.1.70015 Boehringer Ingelheim Investigational Site, Novosibirsk

1276.1.70016 Boehringer Ingelheim Investigational Site, Novosibirsk

1276.1.70018 Boehringer Ingelheim Investigational Site, Novosibirsk

1276.1.70007 Boehringer Ingelheim Investigational Site, Petrozavodsk

1276.1.70005 Boehringer Ingelheim Investigational Site, Saint Petersburg

1276.1.70006 Boehringer Ingelheim Investigational Site, Saint Petersburg

1276.1.70017 Boehringer Ingelheim Investigational Site, Saint Petersburg

1276.1.70009 Boehringer Ingelheim Investigational Site, Saratov

1276.1.70010 Boehringer Ingelheim Investigational Site, Smolensk

1276.1.70013 Boehringer Ingelheim Investigational Site, Yaroslavl

1276.1.38104 Boehringer Ingelheim Investigational Site, Belgrade

1276.1.38105 Boehringer Ingelheim Investigational Site, Belgrade

1276.1.38106 Boehringer Ingelheim Investigational Site, Belgrade

1276.1.38107 Boehringer Ingelheim Investigational Site, Belgrade

1276.1.38103 Boehringer Ingelheim Investigational Site, Kragujevac

1276.1.38101 Boehringer Ingelheim Investigational Site, Niš

1276.1.38108 Boehringer Ingelheim Investigational Site, Novi Sad

1276.1.38102 Boehringer Ingelheim Investigational Site, Zaječar

1276.1.82006 Boehringer Ingelheim Investigational Site, Deagu

1276.1.82010 Boehringer Ingelheim Investigational Site, Goyang

1276.1.82001 Boehringer Ingelheim Investigational Site, Incheon

1276.1.82009 Boehringer Ingelheim Investigational Site, Pusan

1276.1.82002 Boehringer Ingelheim Investigational Site, Seoul

1276.1.82004 Boehringer Ingelheim Investigational Site, Seoul

1276.1.82005 Boehringer Ingelheim Investigational Site, Seoul

1276.1.82007 Boehringer Ingelheim Investigational Site, Seoul

1276.1.82008 Boehringer Ingelheim Investigational Site, Seoul

1276.1.82003 Boehringer Ingelheim Investigational Site, Wŏnju

1276.1.34048 Boehringer Ingelheim Investigational Site, Alicante

1276.1.34050 Boehringer Ingelheim Investigational Site, Alzira

1276.1.34028 Boehringer Ingelheim Investigational Site, Madrid

1276.1.34045 Boehringer Ingelheim Investigational Site, Pozuelo de Alarcón

1276.1.34034 Boehringer Ingelheim Investigational Site, Sabadell (Barcelona)

1276.1.34027 Boehringer Ingelheim Investigational Site, Salamanca

1276.1.34052 Boehringer Ingelheim Investigational Site, Tarragona

1276.1.34051 Boehringer Ingelheim Investigational Site, Zaragoza

1276.1.88005 Boehringer Ingelheim Investigational Site, Kaohsiung City

1276.1.88002 Boehringer Ingelheim Investigational Site, New Taipei City

1276.1.88001 Boehringer Ingelheim Investigational Site, Taichung

1276.1.88003 Boehringer Ingelheim Investigational Site, Taichung

1276.1.88004 Boehringer Ingelheim Investigational Site, Taichung

1276.1.88006 Boehringer Ingelheim Investigational Site, Taipei

1276.1.66001 Boehringer Ingelheim Investigational Site, Bangkok, Thailand

1276.1.66003 Boehringer Ingelheim Investigational Site, Bangkok, Thailand

1276.1.66002 Boehringer Ingelheim Investigational Site, Nakhon Ratchasima

1276.1.90003 Boehringer Ingelheim Investigational Site, Ankara

1276.1.90004 Boehringer Ingelheim Investigational Site, Antalya

1276.1.90006 Boehringer Ingelheim Investigational Site, Denizli

1276.1.90002 Boehringer Ingelheim Investigational Site, Erzurum

1276.1.90005 Boehringer Ingelheim Investigational Site, Istanbul

1276.1.90001 Boehringer Ingelheim Investigational Site, Izmir

1276.1.44002 Boehringer Ingelheim Investigational Site, Bolton

1276.1.44001 Boehringer Ingelheim Investigational Site, Bradford-on-Avon

1276.1.44005 Boehringer Ingelheim Investigational Site, Chippenham

1276.1.44006 Boehringer Ingelheim Investigational Site, Dagenham

1276.1.44004 Boehringer Ingelheim Investigational Site, Doncaster

1276.1.44008 Boehringer Ingelheim Investigational Site, Glasgow

1276.1.44003 Boehringer Ingelheim Investigational Site, Leeds

1276.1.44007 Boehringer Ingelheim Investigational Site, Manchester

1276.1.44011 Boehringer Ingelheim Investigational Site, Mortimer

1276.1.44009 Boehringer Ingelheim Investigational Site, Sandbach

Sponsors
All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

Boehringer Ingelheim

INDUSTRY