Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes

PHASE3CompletedINTERVENTIONAL
Enrollment

2,705

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

May 31, 2013

Study Completion Date

May 31, 2013

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

BI 10773

BI 10773 tablets once daily

DRUG

Placebo

Placebo matching BI 10773 low dose

DRUG

Placebo

Placebo matching BI 10773 high dose

DRUG

Placebo

Placebo matching Sitagliptin

DRUG

Placebo

Placebo matching BI 10773 high dose

DRUG

Placebo

Placebo matching BI 10773 high dose

DRUG

BI 10773

BI 10773 tablets once daily

DRUG

Placebo

Placebo matching BI 10773 low dose

DRUG

Placebo

Placebo matching BI 10773 low dose

DRUG

BI 10773

BI 10773 tablets once daily

DRUG

Placebo

Placebo matching BI 10773 low dose

DRUG

Placebo

Placebo matching BI 10773 high dose

DRUG

Placebo

Placebo matching Sitagliptin

DRUG

BI 10773

BI 10773 tablets once daily

DRUG

BI 10773

BI 10773 tablets once daily

DRUG

BI 10773

BI 10773 tablets once daily

DRUG

Placebo

Placebo matching BI 10773 high dose

DRUG

BI 10773

BI 10773 tablets once daily

DRUG

Placebo

Placebo matching BI 10773 low dose

DRUG

Placebo

Placebo matching BI 10773 high dose

DRUG

Placebo

Placebo matching Sitagliptin

DRUG

Sitagliptin 100mg

Sitagliptin once daily

DRUG

BI 10773

BI 10773 tablets once daily

DRUG

Placebo

Placebo matching BI 10773 low dose

DRUG

Placebo

Placebo matching BI 10773 low dose

DRUG

Placebo

Placebo matching BI 10773 low dose

DRUG

Placebo

Placebo matching BI 10773 high dose

DRUG

Placebo

Placebo matching BI 10773 low dose

DRUG

Placebo

Placebo matching BI 10773 high dose

DRUG

Placebo

Placebo matching BI 10773 high dose

Trial Locations (243)

Unknown

1245.31.10145 Boehringer Ingelheim Investigational Site, Birmingham

1245.31.10162 Boehringer Ingelheim Investigational Site, Glendale

1245.31.10124 Boehringer Ingelheim Investigational Site, Mesa

1245.31.10108 Boehringer Ingelheim Investigational Site, Phoenix

1245.31.10046 Boehringer Ingelheim Investigational Site, Tempe

1245.31.10154 Boehringer Ingelheim Investigational Site, Chino

1245.31.10149 Boehringer Ingelheim Investigational Site, Rancho Cucamonga

1245.31.10131 Boehringer Ingelheim Investigational Site, West Hills

1245.31.10038 Boehringer Ingelheim Investigational Site, Northglenn

1245.31.10127 Boehringer Ingelheim Investigational Site, Waterbury

1245.31.10137 Boehringer Ingelheim Investigational Site, Clearwater

1245.31.10133 Boehringer Ingelheim Investigational Site, Jupiter

1245.31.10006 Boehringer Ingelheim Investigational Site, Miami

1245.31.10085 Boehringer Ingelheim Investigational Site, Plantation

1245.31.10080 Boehringer Ingelheim Investigational Site, Decatur

1245.31.10077 Boehringer Ingelheim Investigational Site, Perry

1245.31.10001 Boehringer Ingelheim Investigational Site, Chicago

1245.31.10159 Boehringer Ingelheim Investigational Site, Des Moines

1245.31.10014 Boehringer Ingelheim Investigational Site, Dubuque

1245.31.10117 Boehringer Ingelheim Investigational Site, Arkansas City

1245.31.10157 Boehringer Ingelheim Investigational Site, Newton

1245.31.10146 Boehringer Ingelheim Investigational Site, Louisville

1245.31.10003 Boehringer Ingelheim Investigational Site, Dearborn

1245.31.10059 Boehringer Ingelheim Investigational Site, New Hyde Park

1245.31.10034 Boehringer Ingelheim Investigational Site, Rochester

1245.31.10123 Boehringer Ingelheim Investigational Site, Smithtown

1245.31.10071 Boehringer Ingelheim Investigational Site, Asheboro

1245.31.10086 Boehringer Ingelheim Investigational Site, Salisbury

1245.31.10129 Boehringer Ingelheim Investigational Site, Carlisle

1245.31.10045 Boehringer Ingelheim Investigational Site, Cincinnati

1245.31.10119 Boehringer Ingelheim Investigational Site, Cincinnati

1245.31.10130 Boehringer Ingelheim Investigational Site, Gallipolis

1245.31.10158 Boehringer Ingelheim Investigational Site, Mt. Pleasant

1245.31.10015 Boehringer Ingelheim Investigational Site, Simpsonville

1245.31.10033 Boehringer Ingelheim Investigational Site, Chattanooga

1245.31.10112 Boehringer Ingelheim Investigational Site, Memphis

1245.31.10156 Boehringer Ingelheim Investigational Site, Houston

1245.31.10151 Boehringer Ingelheim Investigational Site, Hurst

1245.31.10143 Boehringer Ingelheim Investigational Site, Killeen

1245.31.10155 Boehringer Ingelheim Investigational Site, San Antonio

1245.31.32008 Boehringer Ingelheim Investigational Site, Brussels

1245.31.32023 Boehringer Ingelheim Investigational Site, Brussels

1245.31.32003 Boehringer Ingelheim Investigational Site, De Pinte

1245.31.32015 Boehringer Ingelheim Investigational Site, Deurne

1245.31.32016 Boehringer Ingelheim Investigational Site, Deurne

1245.31.32025 Boehringer Ingelheim Investigational Site, Gozée

1245.31.32019 Boehringer Ingelheim Investigational Site, Leopoldsburg

1245.31.32024 Boehringer Ingelheim Investigational Site, Linkebeek

1245.31.32021 Boehringer Ingelheim Investigational Site, Mouscron

1245.31.32020 Boehringer Ingelheim Investigational Site, Sint-Gillis-Waas

1245.31.32018 Boehringer Ingelheim Investigational Site, Tielt

1245.31.32026 Boehringer Ingelheim Investigational Site, Tremelo

1245.31.20032 Boehringer Ingelheim Investigational Site, Calgary

1245.31.20023 Boehringer Ingelheim Investigational Site, Edmonton

1245.31.20011 Boehringer Ingelheim Investigational Site, Chilliwack

1245.31.20028 Boehringer Ingelheim Investigational Site, Vancouver

1245.31.20018 Boehringer Ingelheim Investigational Site, Victoria

1245.31.20033 Boehringer Ingelheim Investigational Site, Victoria

1245.31.20015 Boehringer Ingelheim Investigational Site, Winnipeg

1245.31.20012 Boehringer Ingelheim Investigational Site, Moncton

1245.31.20016 Boehringer Ingelheim Investigational Site, Mount Pearl

1245.31.20024 Boehringer Ingelheim Investigational Site, Paradise

1245.31.20008 Boehringer Ingelheim Investigational Site, St. John's

1245.31.20026 Boehringer Ingelheim Investigational Site, Halifax

1245.31.20022 Boehringer Ingelheim Investigational Site, Brampton

1245.31.20057 Boehringer Ingelheim Investigational Site, Brampton

1245.31.20035 Boehringer Ingelheim Investigational Site, Corunna

1245.31.20030 Boehringer Ingelheim Investigational Site, Etobicoke

1245.31.20019 Boehringer Ingelheim Investigational Site, Hamilton

1245.31.20017 Boehringer Ingelheim Investigational Site, London

1245.31.20029 Boehringer Ingelheim Investigational Site, London

1245.31.20060 Boehringer Ingelheim Investigational Site, London

1245.31.20003 Boehringer Ingelheim Investigational Site, Markham

1245.31.20009 Boehringer Ingelheim Investigational Site, Newmarket

1245.31.20040 Boehringer Ingelheim Investigational Site, Oakville

1245.31.20034 Boehringer Ingelheim Investigational Site, Sarnia

1245.31.20005 Boehringer Ingelheim Investigational Site, Strathroy

1245.31.20002 Boehringer Ingelheim Investigational Site, Toronto

1245.31.20006 Boehringer Ingelheim Investigational Site, Toronto

1245.31.20007 Boehringer Ingelheim Investigational Site, Montague

1245.31.20027 Boehringer Ingelheim Investigational Site, Laval

1245.31.20025 Boehringer Ingelheim Investigational Site, Montreal

1245.31.20058 Boehringer Ingelheim Investigational Site, Saint Romuald

1245.31.20038 Boehringer Ingelheim Investigational Site, Saint-Laurent

1245.31.20036 Boehringer Ingelheim Investigational Site, Sherbrooke

1245.31.20021 Boehringer Ingelheim Investigational Site, Trois-Rivières

1245.31.20041 Boehringer Ingelheim Investigational Site, Saskatoon

1245.31.86007 Boehringer Ingelheim Investigational Site, Beijing

1245.31.86008 Boehringer Ingelheim Investigational Site, Beijing

1245.31.86031 Boehringer Ingelheim Investigational Site, Beijing

1245.31.86032 Boehringer Ingelheim Investigational Site, Beijing

1245.31.86033 Boehringer Ingelheim Investigational Site, Beijing

1245.31.86034 Boehringer Ingelheim Investigational Site, Beijing

1245.31.86035 Boehringer Ingelheim Investigational Site, Beijing

1245.31.86058 Boehringer Ingelheim Investigational Site, Chongqing

1245.31.86038 Boehringer Ingelheim Investigational Site, Dalian

1245.31.86001 Boehringer Ingelheim Investigational Site, Guangzhou

1245.31.86003 Boehringer Ingelheim Investigational Site, Guangzhou

1245.31.86052 Boehringer Ingelheim Investigational Site, Guangzhou

1245.31.86012 Boehringer Ingelheim Investigational Site, Guiyang

1245.31.86037 Boehringer Ingelheim Investigational Site, Haerbin

1245.31.86020 Boehringer Ingelheim Investigational Site, Hangzhou

1245.31.86049 Boehringer Ingelheim Investigational Site, Jinan

1245.31.86053 Boehringer Ingelheim Investigational Site, Jinan

1245.31.86018 Boehringer Ingelheim Investigational Site, Jingzhou

1245.31.86019 Boehringer Ingelheim Investigational Site, Nanchang

1245.31.86042 Boehringer Ingelheim Investigational Site, Nanjing

1245.31.86043 Boehringer Ingelheim Investigational Site, Nanjing

1245.31.86055 Boehringer Ingelheim Investigational Site, Nanning

1245.31.86056 Boehringer Ingelheim Investigational Site, Nanning

1245.31.86016 Boehringer Ingelheim Investigational Site, Qingdao

1245.31.86039 Boehringer Ingelheim Investigational Site, Shanghai

1245.31.86054 Boehringer Ingelheim Investigational Site, Shantou

1245.31.86057 Boehringer Ingelheim Investigational Site, Shenyang

1245.31.86045 Boehringer Ingelheim Investigational Site, Shijiazhuang

1245.31.86017 Boehringer Ingelheim Investigational Site, Shiyan

1245.31.86013 Boehringer Ingelheim Investigational Site, Suzhou

1245.31.86015 Boehringer Ingelheim Investigational Site, Taiyuan

1245.31.86036 Boehringer Ingelheim Investigational Site, Tianjin

1245.31.86011 Boehringer Ingelheim Investigational Site, Xi'an

1245.31.86041 Boehringer Ingelheim Investigational Site, Xi'an

1245.31.86014 Boehringer Ingelheim Investigational Site, Xiamen

1245.31.33008 Boehringer Ingelheim Investigational Site, Bersée

1245.31.33020 Boehringer Ingelheim Investigational Site, Bischheim

1245.31.33002 Boehringer Ingelheim Investigational Site, Bondy

1245.31.33016 Boehringer Ingelheim Investigational Site, Bruay-la-Buissière

1245.31.33001 Boehringer Ingelheim Investigational Site, Corbeil-Essonnes

1245.31.33010 Boehringer Ingelheim Investigational Site, Croix

1245.31.33009 Boehringer Ingelheim Investigational Site, Hautmont

1245.31.33003 Boehringer Ingelheim Investigational Site, La Rochelle

1245.31.33045 Boehringer Ingelheim Investigational Site, Marseille

1245.31.33004 Boehringer Ingelheim Investigational Site, Narbonne

1245.31.33012 Boehringer Ingelheim Investigational Site, Schiltigheim

1245.31.33013 Boehringer Ingelheim Investigational Site, Strasbourg

1245.31.33019 Boehringer Ingelheim Investigational Site, Strasbourg

1245.31.33007 Boehringer Ingelheim Investigational Site, Vieux-Condé

1245.31.33018 Boehringer Ingelheim Investigational Site, Wattrelos

1245.31.49001 Boehringer Ingelheim Investigational Site, Dormagen

1245.31.49013 Boehringer Ingelheim Investigational Site, Dresden

1245.31.49016 Boehringer Ingelheim Investigational Site, Düsseldorf

1245.31.49009 Boehringer Ingelheim Investigational Site, Flörsheim

1245.31.49015 Boehringer Ingelheim Investigational Site, Frankfurt

1245.31.49019 Boehringer Ingelheim Investigational Site, Haag

1245.31.49004 Boehringer Ingelheim Investigational Site, Hatten

1245.31.49020 Boehringer Ingelheim Investigational Site, Hohenmölsen

1245.31.49007 Boehringer Ingelheim Investigational Site, Künzing

1245.31.49002 Boehringer Ingelheim Investigational Site, Neuwied

1245.31.49008 Boehringer Ingelheim Investigational Site, Nuremberg

1245.31.49010 Boehringer Ingelheim Investigational Site, Rednitzhembach

1245.31.49006 Boehringer Ingelheim Investigational Site, Rehburg-Loccum

1245.31.49011 Boehringer Ingelheim Investigational Site, Rehlingen-Siersburg

1245.31.49005 Boehringer Ingelheim Investigational Site, Saarbrücken

1245.31.49017 Boehringer Ingelheim Investigational Site, Saint Ingbert/Oberwürzbach

1245.31.49022 Boehringer Ingelheim Investigational Site, Schauenburg

1245.31.49003 Boehringer Ingelheim Investigational Site, Unterschneidheim

1245.31.30004 Boehringer Ingelheim Investigational Site, Thessaloniki

1245.31.91005 Boehringer Ingelheim Investigational Site, Bangalore

1245.31.91006 Boehringer Ingelheim Investigational Site, Bangalore

1245.31.91008 Boehringer Ingelheim Investigational Site, Bangalore

1245.31.91003 Boehringer Ingelheim Investigational Site, Belagavi

1245.31.91004 Boehringer Ingelheim Investigational Site, Chennai

1245.31.91009 Boehringer Ingelheim Investigational Site, Chennai

1245.31.91001 Boehringer Ingelheim Investigational Site, Coimbatore

1245.31.91101 Boehringer Ingelheim Investigational Site, Coimbatore

1245.31.91104 Boehringer Ingelheim Investigational Site, Indore

1245.31.91015 Boehringer Ingelheim Investigational Site, Kalaburagi

1245.31.91103 Boehringer Ingelheim Investigational Site, Maharashtra

1245.31.91002 Boehringer Ingelheim Investigational Site, Mumbai

1245.31.91007 Boehringer Ingelheim Investigational Site, Mumbai, Maharastra

1245.31.91010 Boehringer Ingelheim Investigational Site, Nagpur

1245.31.91012 Boehringer Ingelheim Investigational Site, New Delhi

1245.31.91014 Boehringer Ingelheim Investigational Site, Pune

1245.31.91105 Boehringer Ingelheim Investigational Site, Pune

1245.31.35304 Boehringer Ingelheim Investigational Site, Birr, Co. Offaly

1245.31.35302 Boehringer Ingelheim Investigational Site, Co. Cork

1245.31.35305 Boehringer Ingelheim Investigational Site, Co. Galway

1245.31.35303 Boehringer Ingelheim Investigational Site, Co. Wexford

1245.31.35306 Boehringer Ingelheim Investigational Site, Co. Wexford

1245.31.81007 Boehringer Ingelheim Investigational Site, Chiyoda-ku, Tokyo

1245.31.81001 Boehringer Ingelheim Investigational Site, Chuo-ku, Tokyo

1245.31.81002 Boehringer Ingelheim Investigational Site, Chuo-ku, Tokyo

1245.31.81005 Boehringer Ingelheim Investigational Site, Ebetsu, Hokkaido

1245.31.81004 Boehringer Ingelheim Investigational Site, Kamakura, Kanagawa

1245.31.81003 Boehringer Ingelheim Investigational Site, Minato-ku, Tokyo

1245.31.81006 Boehringer Ingelheim Investigational Site, Shinjuku-ku, Tokyo

1245.31.81008 Boehringer Ingelheim Investigational Site, Shinjuku-ku, Tokyo

1245.31.81009 Boehringer Ingelheim Investigational Site, Suita, Osaka

1245.31.81010 Boehringer Ingelheim Investigational Site, Ube, Yamaguchi

1245.31.81012 Boehringer Ingelheim Investigational Site, Urasoe, Okinawa

1245.31.81013 Boehringer Ingelheim Investigational Site, Urasoe, Okinawa

1245.31.52003 Boehringer Ingelheim Investigational Site, Guadalajara

1245.31.52004 Boehringer Ingelheim Investigational Site, Guadalajara

1245.31.52001 Boehringer Ingelheim Investigational Site, Monterrey

1245.31.52002 Boehringer Ingelheim Investigational Site, Monterrey

1245.31.63002 Boehringer Ingelheim Investigational Site, Cebu

1245.31.63003 Boehringer Ingelheim Investigational Site, Davao City

1245.31.63001 Boehringer Ingelheim Investigational Site, Manila

1245.31.63004 Boehringer Ingelheim Investigational Site, Manila

1245.31.63005 Boehringer Ingelheim Investigational Site, Manila

1245.31.74005 Boehringer Ingelheim Investigational Site, Bratislava

1245.31.74002 Boehringer Ingelheim Investigational Site, Lučenec

1245.31.74006 Boehringer Ingelheim Investigational Site, Nitra

1245.31.74014 Boehringer Ingelheim Investigational Site, Nové Zámky

1245.31.74001 Boehringer Ingelheim Investigational Site, Považská Bystrica

1245.31.74004 Boehringer Ingelheim Investigational Site, Prešov

1245.31.74003 Boehringer Ingelheim Investigational Site, Trebišov

1245.31.38003 Boehringer Ingelheim Investigational Site, Celje

1245.31.38002 Boehringer Ingelheim Investigational Site, Koper

1245.31.38001 Boehringer Ingelheim Investigational Site, Maribor

1245.31.82012 Boehringer Ingelheim Investigational Site, Anyang

1245.31.82011 Boehringer Ingelheim Investigational Site, Goyang

1245.31.82009 Boehringer Ingelheim Investigational Site, Ilsan

1245.31.82001 Boehringer Ingelheim Investigational Site, Incheon

1245.31.82006 Boehringer Ingelheim Investigational Site, Jeonju

1245.31.82004 Boehringer Ingelheim Investigational Site, Pusan

1245.31.82005 Boehringer Ingelheim Investigational Site, Seoul

1245.31.82007 Boehringer Ingelheim Investigational Site, Seoul

1245.31.82008 Boehringer Ingelheim Investigational Site, Seoul

1245.31.82010 Boehringer Ingelheim Investigational Site, Seoul

1245.31.82014 Boehringer Ingelheim Investigational Site, Seoul

1245.31.82002 Boehringer Ingelheim Investigational Site, Suwon

1245.31.82003 Boehringer Ingelheim Investigational Site, Wŏnju

1245.31.41004 Boehringer Ingelheim Investigational Site, Lugano

1245.31.41003 Boehringer Ingelheim Investigational Site, Rorschach

1245.31.88010 Boehringer Ingelheim Investigational Site, Kaohsiung City

1245.31.88011 Boehringer Ingelheim Investigational Site, Kaohsiung City

1245.31.88012 Boehringer Ingelheim Investigational Site, Kaohsiung City

1245.31.88013 Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

1245.31.88009 Boehringer Ingelheim Investigational Site, Taichung

1245.31.88014 Boehringer Ingelheim Investigational Site, Tainan City

1245.31.88006 Boehringer Ingelheim Investigational Site, Taipei

1245.31.88021 Boehringer Ingelheim Investigational Site, Taipei

1245.31.88008 Boehringer Ingelheim Investigational Site, Taoyuan

1245.31.90003 Boehringer Ingelheim Investigational Site, Erzurum

1245.31.90001 Boehringer Ingelheim Investigational Site, Gaziantep

1245.31.90002 Boehringer Ingelheim Investigational Site, Istanbul

1245.31.90006 Boehringer Ingelheim Investigational Site, Istanbul

1245.31.90004 Boehringer Ingelheim Investigational Site, Izmir

1245.31.75002 Boehringer Ingelheim Investigational Site, Dnipro

1245.31.75001 Boehringer Ingelheim Investigational Site, Kharkiv

1245.31.75006 Boehringer Ingelheim Investigational Site, Lviv

1245.31.75004 Boehringer Ingelheim Investigational Site, Vinnitsa

1245.31.75003 Boehringer Ingelheim Investigational Site, Vinnytsia

Sponsors
All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

Boehringer Ingelheim

INDUSTRY