Diabetes Mellitus, Type 2Phase 3NCT01289990

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

A Phase 3 study testing BI 10773 and Sitagliptin 100mg in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 243 sites in 19 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 study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients. 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?: BI 10773 and Sitagliptin 100mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,705 participants
Where: 243 sitesin 19 countries
Study dates: Feb 2011to May 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

Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy.
Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and local legislation.

Who cannot join

Patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23.
Indication of liver disease, defined by serum levels of either alanine aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during last visit of preceding trial.
Impaired renal function defined as glomerular filtration rate<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) as determined during last visit of preceding trial.
Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23
Pre-menopausal women (last menstruation < or = 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.
Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake.
Participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23).
Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.

Trial locations and contacts

243 sites in 19 countries.

Country

City, postcode or hospital

243 sites in 19 countries

United States40 sites

1245.31.10117 Boehringer Ingelheim Investigational Site
Arkansas City, Kansas
1245.31.10071 Boehringer Ingelheim Investigational Site
Asheboro, North Carolina
1245.31.10145 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1245.31.10129 Boehringer Ingelheim Investigational Site
Carlisle, Ohio
1245.31.10033 Boehringer Ingelheim Investigational Site
Chattanooga, Tennessee
1245.31.10001 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1245.31.10154 Boehringer Ingelheim Investigational Site
Chino, California
1245.31.10045 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1245.31.10119 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1245.31.10137 Boehringer Ingelheim Investigational Site
Clearwater, Florida
1245.31.10003 Boehringer Ingelheim Investigational Site
Dearborn, Michigan
1245.31.10080 Boehringer Ingelheim Investigational Site
Decatur, Georgia
1245.31.10159 Boehringer Ingelheim Investigational Site
Des Moines, Iowa
1245.31.10014 Boehringer Ingelheim Investigational Site
Dubuque, Iowa
1245.31.10130 Boehringer Ingelheim Investigational Site
Gallipolis, Ohio
1245.31.10162 Boehringer Ingelheim Investigational Site
Glendale, Arizona
1245.31.10156 Boehringer Ingelheim Investigational Site
Houston, Texas
1245.31.10151 Boehringer Ingelheim Investigational Site
Hurst, Texas
1245.31.10133 Boehringer Ingelheim Investigational Site
Jupiter, Florida
1245.31.10143 Boehringer Ingelheim Investigational Site
Killeen, Texas
1245.31.10146 Boehringer Ingelheim Investigational Site
Louisville, Kentucky
1245.31.10112 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
1245.31.10124 Boehringer Ingelheim Investigational Site
Mesa, Arizona
1245.31.10006 Boehringer Ingelheim Investigational Site
Miami, Florida
1245.31.10158 Boehringer Ingelheim Investigational Site
Mt. Pleasant, South Carolina
1245.31.10059 Boehringer Ingelheim Investigational Site
New Hyde Park, New York
1245.31.10157 Boehringer Ingelheim Investigational Site
Newton, Kansas
1245.31.10038 Boehringer Ingelheim Investigational Site
Northglenn, Colorado
1245.31.10077 Boehringer Ingelheim Investigational Site
Perry, Georgia
1245.31.10108 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
1245.31.10085 Boehringer Ingelheim Investigational Site
Plantation, Florida
1245.31.10149 Boehringer Ingelheim Investigational Site
Rancho Cucamonga, California
1245.31.10034 Boehringer Ingelheim Investigational Site
Rochester, New York
1245.31.10086 Boehringer Ingelheim Investigational Site
Salisbury, North Carolina
1245.31.10155 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1245.31.10015 Boehringer Ingelheim Investigational Site
Simpsonville, South Carolina
1245.31.10123 Boehringer Ingelheim Investigational Site
Smithtown, New York
1245.31.10046 Boehringer Ingelheim Investigational Site
Tempe, Arizona
1245.31.10127 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut
1245.31.10131 Boehringer Ingelheim Investigational Site
West Hills, California

Other trials in United States

Canada35 sites

1245.31.20022 Boehringer Ingelheim Investigational Site
Brampton, Ontario
1245.31.20057 Boehringer Ingelheim Investigational Site
Brampton, Ontario
1245.31.20032 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1245.31.20011 Boehringer Ingelheim Investigational Site
Chilliwack, British Columbia
1245.31.20035 Boehringer Ingelheim Investigational Site
Corunna, Ontario
1245.31.20023 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1245.31.20030 Boehringer Ingelheim Investigational Site
Etobicoke, Ontario
1245.31.20026 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
1245.31.20019 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1245.31.20027 Boehringer Ingelheim Investigational Site
Laval, Quebec
1245.31.20017 Boehringer Ingelheim Investigational Site
London, Ontario
1245.31.20029 Boehringer Ingelheim Investigational Site
London, Ontario
1245.31.20060 Boehringer Ingelheim Investigational Site
London, Ontario
1245.31.20003 Boehringer Ingelheim Investigational Site
Markham, Ontario
1245.31.20012 Boehringer Ingelheim Investigational Site
Moncton, New Brunswick
1245.31.20007 Boehringer Ingelheim Investigational Site
Montague, Prince Edward Island
1245.31.20025 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1245.31.20016 Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador
1245.31.20009 Boehringer Ingelheim Investigational Site
Newmarket, Ontario
1245.31.20040 Boehringer Ingelheim Investigational Site
Oakville, Ontario
1245.31.20024 Boehringer Ingelheim Investigational Site
Paradise, Newfoundland and Labrador
1245.31.20058 Boehringer Ingelheim Investigational Site
Saint Romuald, Quebec
1245.31.20038 Boehringer Ingelheim Investigational Site
Saint-Laurent, Quebec
1245.31.20034 Boehringer Ingelheim Investigational Site
Sarnia, Ontario
1245.31.20041 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
1245.31.20036 Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec
1245.31.20008 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador
1245.31.20005 Boehringer Ingelheim Investigational Site
Strathroy, Ontario
1245.31.20002 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1245.31.20006 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1245.31.20021 Boehringer Ingelheim Investigational Site
Trois-Rivières, Quebec
1245.31.20028 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1245.31.20018 Boehringer Ingelheim Investigational Site
Victoria, British Columbia
1245.31.20033 Boehringer Ingelheim Investigational Site
Victoria, British Columbia
1245.31.20015 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba

Other trials in Canada

China35 sites

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

Other trials in China

Germany18 sites

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

Other trials in Germany

India17 sites

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

Other trials in India

France15 sites

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

Other trials in France

South Korea13 sites

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

Other trials in South Korea

Belgium12 sites

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

Other trials in Belgium

Japan12 sites

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

Other trials in Japan

Taiwan9 sites

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
1245.31.88006 Boehringer Ingelheim Investigational Site
Taipei
1245.31.88021 Boehringer Ingelheim Investigational Site
Taipei
1245.31.88008 Boehringer Ingelheim Investigational Site
Taoyuan County

Other trials in Taiwan

Slovakia7 sites

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

Other trials in Slovakia

Ireland5 sites

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

Other trials in Ireland

Philippines5 sites

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

Other trials in Philippines

Turkey (Türkiye)5 sites

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

Other trials in Turkey (Türkiye)

Ukraine5 sites

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

Other trials in Ukraine

Mexico4 sites

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

Other trials in Mexico

Slovenia3 sites

1245.31.38003 Boehringer Ingelheim Investigational Site
Celje
1245.31.38002 Boehringer Ingelheim Investigational Site
Koper
1245.31.38001 Boehringer Ingelheim Investigational Site
Maribor

Other trials in Slovenia

Switzerland2 sites

1245.31.41004 Boehringer Ingelheim Investigational Site
Lugano
1245.31.41003 Boehringer Ingelheim Investigational Site
Rorschach

Other trials in Switzerland

Greece1 site

1245.31.30004 Boehringer Ingelheim Investigational Site
Thessaloniki

Other trials in Greece

About this study

Official title: A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23

This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.

Conditions: Diabetes Mellitus, Type 2
Being tested: BI 10773, Placebo, Sitagliptin 100mg
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
BI 10773 tablets once daily
PlaceboDrug
Placebo matching BI 10773 low dose
PlaceboDrug
Placebo matching BI 10773 high dose
PlaceboDrug
Placebo matching Sitagliptin
PlaceboDrug
Placebo matching BI 10773 high dose
PlaceboDrug
Placebo matching BI 10773 high dose
BI 10773Drug
BI 10773 tablets once daily
PlaceboDrug
Placebo matching BI 10773 low dose
PlaceboDrug
Placebo matching BI 10773 low dose
BI 10773Drug
BI 10773 tablets once daily
PlaceboDrug
Placebo matching BI 10773 low dose
PlaceboDrug
Placebo matching BI 10773 high dose
PlaceboDrug
Placebo matching Sitagliptin
BI 10773Drug
BI 10773 tablets once daily
BI 10773Drug
BI 10773 tablets once daily
BI 10773Drug
BI 10773 tablets once daily
PlaceboDrug
Placebo matching BI 10773 high dose
BI 10773Drug
BI 10773 tablets once daily
PlaceboDrug
Placebo matching BI 10773 low dose
PlaceboDrug
Placebo matching BI 10773 high dose
PlaceboDrug
Placebo matching Sitagliptin
Sitagliptin 100mgDrug
Sitagliptin once daily
BI 10773Drug
BI 10773 tablets once daily
PlaceboDrug
Placebo matching BI 10773 low dose
PlaceboDrug
Placebo matching BI 10773 low dose
PlaceboDrug
Placebo matching BI 10773 low dose
PlaceboDrug
Placebo matching BI 10773 high dose
PlaceboDrug
Placebo matching BI 10773 low dose
PlaceboDrug
Placebo matching BI 10773 high dose
PlaceboDrug
Placebo matching BI 10773 high dose

Study groups in NCT01289990
Study group	Role	What they receive
BI 10773 low (drug naive)	Experimental	BI 10773 tablets once daily Receives: Drug: BI 10773; Drug: Placebo
BI 10773 high (drug naive)	Experimental	BI 10773 tablets once daily Receives: Drug: Placebo; Drug: BI 10773
Placebo (drug naive)	Placebo comparator	Placebo tablets matching BI 10773 / Sitagliptin once daily Receives: Drug: Placebo
Sitagliptin 100mg (drug naive)	Active comparator	Sitagliptin once daily Receives: Drug: Placebo; Drug: Sitagliptin 100mg
BI 10773 low (pioglitazone)	Experimental	BI 10773 tablets once daily Receives: Drug: BI 10773; Drug: Placebo
BI 10773 high (pioglitazone)	Experimental	BI 10773 tablets once daily Receives: Drug: BI 10773; Drug: Placebo
Placebo (pioglitazone)	Placebo comparator	Placebo tablets matching BI 10773 once daily Receives: Drug: Placebo
BI 10773 low (metformin)	Experimental	BI 10773 tablets once daily Receives: Drug: Placebo; Drug: BI 10773
BI 10773 high (metformin)	Experimental	BI 10773 tablets once daily Receives: Drug: BI 10773; Drug: Placebo
Placebo (metformin)	Placebo comparator	Placebo tablets matching BI 10773 once daily Receives: Drug: Placebo
BI 10773 low (metformin+sulfonylurea)	Experimental	BI 10773 tablets once daily Receives: Drug: BI 10773; Drug: Placebo
BI 10773 high (metformin+sulfonylurea)	Experimental	BI 10773 tablets once daily Receives: Drug: BI 10773; Drug: Placebo
Placebo (metformin+sulfonylurea)	Placebo comparator	Placebo tablets matching BI 10773 Receives: Drug: Placebo

What is being measured

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

Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Change from baseline in HbA1c after 52 weeks
Measured: Baseline and 52 weeks
Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Change from baseline in HbA1c after 76 weeks
Measured: Baseline and 76 weeks

Secondary outcomes (11)

HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Change from baseline in HbA1c (%) after 76 weeks using MMRM approach
Measured: Baseline and 76 weeks
Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Systolic blood pressure - change from baseline after 52 weeks of treatment
Measured: Baseline and 52 weeks
Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Systolic blood pressure - change from baseline after 76 weeks of treatment
Measured: Baseline and 76 weeks
Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Diastolic blood pressure - change from baseline after 52 weeks of treatment
Measured: Baseline and 52 weeks
Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Diastolic blood pressure - change from baseline after 76 weeks of treatment
Measured: Baseline and 76 weeks
Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment
Measured: Baseline and 52 weeks
Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment
Measured: Baseline and 76 weeks
Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Waist circumference (cm) - change from baseline after 52 weeks of treatment
Measured: Baseline and 52 weeks
Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Waist circumference (cm) - change from baseline after 76 weeks of treatment
Measured: Baseline and 76 weeks
Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment
Fasting plasma glucose - change from baseline after 52 weeks of treatment
Measured: Baseline and 52 weeks
Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment
Fasting plasma glucose - change from baseline after 76 weeks of treatment
Measured: Baseline and 76 weeks

Timeline

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

Feb 2011May 2013

First posted4 Feb 2011 (estimated)
Study startFeb 2011
Primary completionMay 2013
Study completionMay 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 (5)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: Non-randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 2,705 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01289990
Sponsor's protocol ID: 1245.31
Other IDs: 2010-022718-17
Status last verified: Jul 2014
First submitted: 31 Jan 2011
Last updated: 15 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
PubMed 35472672
Inzucchi SE, Davies MJ, Khunti K, Trivedi P, George JT, Zwiener I, Johansen OE, Sattar N. Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Feb;23(2):425-433. doi: 10.1111/dom.14234. Epub 2020 Nov 20.
PubMed 33084149
Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.
PubMed 28753486
Roden M, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Stella P, Woerle HJ, Broedl UC; EMPA-REG EXTEND MONO investigators. Safety, tolerability and effects on cardiometabolic risk factors of empagliflozin monotherapy in drug-naive patients with type 2 diabetes: a double-blind extension of a Phase III randomized controlled trial. Cardiovasc Diabetol. 2015 Dec 23;14:154. doi: 10.1186/s12933-015-0314-0.
PubMed 26701110
Haering HU, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Meinicke T, Woerle HJ, Broedl UC; EMPA-REG EXTEND METSU investigators. Empagliflozin as add-on to metformin plus sulphonylurea in patients with type 2 diabetes. Diabetes Res Clin Pract. 2015 Oct;110(1):82-90. doi: 10.1016/j.diabres.2015.05.044. Epub 2015 May 29.
PubMed 26324220

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?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23
ClinicalTrials.gov ID: NCT01289990
Acronym / sponsor ID: 1245.31
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,705 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Feb 2011
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 4 Feb 2011 (estimated)
Results: Posted 15 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 13

Arm	Type	Receives
BI 10773 low (drug naive)	Experimental	Drug: BI 10773, Drug: PlaceboBI 10773 tablets once daily
BI 10773 high (drug naive)	Experimental	Drug: Placebo, Drug: BI 10773BI 10773 tablets once daily
Placebo (drug naive)	Placebo comparator	Drug: PlaceboPlacebo tablets matching BI 10773 / Sitagliptin once daily
Sitagliptin 100mg (drug naive)	Active comparator	Drug: Placebo, Drug: Sitagliptin 100mgSitagliptin once daily
BI 10773 low (pioglitazone)	Experimental	Drug: BI 10773, Drug: PlaceboBI 10773 tablets once daily
BI 10773 high (pioglitazone)	Experimental	Drug: BI 10773, Drug: PlaceboBI 10773 tablets once daily
Placebo (pioglitazone)	Placebo comparator	Drug: PlaceboPlacebo tablets matching BI 10773 once daily
BI 10773 low (metformin)	Experimental	Drug: Placebo, Drug: BI 10773BI 10773 tablets once daily
BI 10773 high (metformin)	Experimental	Drug: BI 10773, Drug: PlaceboBI 10773 tablets once daily
Placebo (metformin)	Placebo comparator	Drug: PlaceboPlacebo tablets matching BI 10773 once daily
BI 10773 low (metformin+sulfonylurea)	Experimental	Drug: BI 10773, Drug: PlaceboBI 10773 tablets once daily
BI 10773 high (metformin+sulfonylurea)	Experimental	Drug: BI 10773, Drug: PlaceboBI 10773 tablets once daily
Placebo (metformin+sulfonylurea)	Placebo comparator	Drug: PlaceboPlacebo tablets matching BI 10773

Who may qualify

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

Key inclusion criteria (2 listed)

Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy.
Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and local legislation.

Key exclusion criteria (8 listed)

Patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23.
Indication of liver disease, defined by serum levels of either alanine aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during last visit of preceding trial.
Impaired renal function defined as glomerular filtration rate<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) as determined during last visit of preceding trial.
Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23
Pre-menopausal women (last menstruation < or = 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.

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 10773BI 10773 tablets once daily	Drug	BI 10773 low (drug naive)
PlaceboPlacebo matching BI 10773 low dose	Drug	Placebo (drug naive)
PlaceboPlacebo matching BI 10773 high dose	Drug	Sitagliptin 100mg (drug naive)
PlaceboPlacebo matching Sitagliptin	Drug	Placebo (drug naive)
PlaceboPlacebo matching BI 10773 high dose	Drug	BI 10773 low (metformin)
PlaceboPlacebo matching BI 10773 high dose	Drug	Placebo (drug naive)
BI 10773BI 10773 tablets once daily	Drug	BI 10773 high (metformin)
PlaceboPlacebo matching BI 10773 low dose	Drug	Placebo (pioglitazone)
PlaceboPlacebo matching BI 10773 low dose	Drug	Sitagliptin 100mg (drug naive)
BI 10773BI 10773 tablets once daily	Drug	BI 10773 low (pioglitazone)
PlaceboPlacebo matching BI 10773 low dose	Drug	Placebo (metformin)
PlaceboPlacebo matching BI 10773 high dose	Drug	BI 10773 low (pioglitazone)
PlaceboPlacebo matching Sitagliptin	Drug	BI 10773 high (drug naive)
BI 10773BI 10773 tablets once daily	Drug	BI 10773 low (metformin)
BI 10773BI 10773 tablets once daily	Drug	BI 10773 low (metformin+sulfonylurea)
BI 10773BI 10773 tablets once daily	Drug	BI 10773 high (drug naive)
PlaceboPlacebo matching BI 10773 high dose	Drug	Placebo (metformin)
BI 10773BI 10773 tablets once daily	Drug	BI 10773 high (metformin+sulfonylurea)
PlaceboPlacebo matching BI 10773 low dose	Drug	BI 10773 high (metformin+sulfonylurea)
PlaceboPlacebo matching BI 10773 high dose	Drug	Placebo (pioglitazone)
PlaceboPlacebo matching Sitagliptin	Drug	BI 10773 low (drug naive)
Sitagliptin 100mgSitagliptin once daily	Drug	Sitagliptin 100mg (drug naive)
BI 10773BI 10773 tablets once daily	Drug	BI 10773 high (pioglitazone)
PlaceboPlacebo matching BI 10773 low dose	Drug	BI 10773 high (pioglitazone)
PlaceboPlacebo matching BI 10773 low dose	Drug	Placebo (metformin+sulfonylurea)
PlaceboPlacebo matching BI 10773 low dose	Drug	BI 10773 high (drug naive)
PlaceboPlacebo matching BI 10773 high dose	Drug	Placebo (metformin+sulfonylurea)
PlaceboPlacebo matching BI 10773 low dose	Drug	BI 10773 high (metformin)
PlaceboPlacebo matching BI 10773 high dose	Drug	BI 10773 low (metformin+sulfonylurea)
PlaceboPlacebo matching BI 10773 high dose	Drug	BI 10773 low (drug naive)

Primary outcome

Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Time frame: Baseline and 52 weeks
Change from baseline in HbA1c after 52 weeks
Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Time frame: Baseline and 76 weeks
Change from baseline in HbA1c after 76 weeks

11 secondary outcomes

HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Time frame: Baseline and 76 weeks
Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Time frame: Baseline and 52 weeks
Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Time frame: Baseline and 76 weeks
Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Time frame: Baseline and 52 weeks
Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Time frame: Baseline and 76 weeks
Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Time frame: Baseline and 52 weeks
Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Time frame: Baseline and 76 weeks
Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Time frame: Baseline and 52 weeks
Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Time frame: Baseline and 76 weeks
Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment
Time frame: Baseline and 52 weeks
Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment
Time frame: Baseline and 76 weeks

Results and safety

Results posted to the registry on 15 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Empagliflozin 10 mg (Drug Naive)	224	147
Empagliflozin 25 mg (Drug Naive)	224	143
Placebo (Drug Naive)	228	119
Sitagliptin 100mg (Drug Naive)	223	136
Empagliflozin 10 mg (Pioglitazone)	165	93
Empagliflozin 25 mg (Pioglitazone)	168	94
Placebo (Pioglitazone)	166	78
Empagliflozin 10 mg (Metformin)	217	162
Empagliflozin 25 mg (Metformin)	214	139
Placebo (Metformin)	207	121
Empagliflozin 10 mg (Metformin+Sulfonylurea)	226	150
Empagliflozin 25 mg (Metformin+Sulfonylurea)	218	150
Placebo (Metformin+Sulfonylurea)	225	127

Primary outcome: Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment

Time frame: Baseline and 52 weeks. Least squares mean (Standard Error). Unit: % of HbA1c

Measure	BI 10773 Low (Drug Naive) n = 224	BI 10773 High (Drug Naive) n = 224	Placebo (Drug Naive) n = 228	Sitagliptin 100mg (Drug Naive) n = 223	BI 10773 Low (Pioglitazone) n = 165	BI 10773 High (Pioglitazone) n = 168	Placebo (Pioglitazone) n = 165	BI 10773 Low (Metformin) n = 217	BI 10773 High (Metformin) n = 213	Placebo (Metformin) n = 207	BI 10773 Low (Metformin+Sulfonylurea) n = 225	BI 10773 High (Metformin+Sulfonylurea) n = 216	Placebo (Metformin+Sulfonylurea) n = 225
Value	-0.70 (0.05)	-0.82 (0.05)	0.09 (0.05)	-0.58 (0.05)	-0.63 (0.07)	-0.71 (0.07)	-0.03 (0.07)	-0.69 (0.05)	-0.76 (0.05)	-0.07 (0.05)	-0.78 (0.05)	-0.74 (0.05)	-0.04 (0.05)

BI 10773 Low (Drug Naive) vs Placebo (Drug Naive): Adjusted mean difference: -0.79 (95% CI -0.94 to -0.64), p <0.0001, ANCOVA
BI 10773 High (Drug Naive) vs Placebo (Drug Naive): Adjusted mean difference: -0.91 (95% CI -1.06 to -0.76), p <0.0001, ANCOVA
Placebo (Drug Naive) vs Sitagliptin 100mg (Drug Naive): Adjusted mean difference: -0.67 (95% CI -0.82 to -0.52), p <0.0001, ANCOVA

Population analysed: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial. (LOCF:Last observation carried forward)

Primary outcome: Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment

Time frame: Baseline and 76 weeks. Least squares mean (Standard Deviation). Unit: % of HbA1c

Measure	BI 10773 Low (Drug Naive) n = 224	BI 10773 High (Drug Naive) n = 224	Placebo (Drug Naive) n = 228	Sitagliptin 100mg (Drug Naive) n = 223	BI 10773 Low (Pioglitazone) n = 165	BI 10773 High (Pioglitazone) n = 168	Placebo (Pioglitazone) n = 165	BI 10773 Low (Metformin) n = 217	BI 10773 High (Metformin) n = 213	Placebo (Metformin) n = 207	BI 10773 Low (Metformin+Sulfonylurea) n = 225	BI 10773 High (Metformin+Sulfonylurea) n = 216	Placebo (Metformin+Sulfonylurea) n = 225
Value	-0.65 (0.06)	-0.76 (0.06)	0.13 (0.06)	-0.53 (0.06)	-0.61 (0.07)	-0.70 (0.07)	-0.01 (0.07)	-0.62 (0.05)	-0.74 (0.05)	-0.01 (0.05)	-0.74 (0.06)	-0.72 (0.06)	-0.03 (0.06)

BI 10773 Low (Drug Naive) vs Placebo (Drug Naive): Adjusted mean difference: -0.78 (95% CI -0.94 to -0.63), p <0.0001, ANCOVA
BI 10773 High (Drug Naive) vs Placebo (Drug Naive): Adjusted mean difference: -0.89 (95% CI -1.04 to -0.73), p <0.0001, ANCOVA
Placebo (Drug Naive) vs Sitagliptin 100mg (Drug Naive): Adjusted mean difference: -0.66 (95% CI -0.82 to -0.51), p <0.0001, ANCOVA

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing of the informed consent until 7 days (inclusive) after last treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empagliflozin 10 mg (Drug Naive)	23 of 229 (10%)	134 of 229 (58.5%)	Not reported
Empagliflozin 25 mg (Drug Naive)	25 of 224 (11.2%)	110 of 224 (49.1%)	Not reported
Placebo (Drug Naive)	16 of 223 (7.2%)	92 of 223 (41.3%)	Not reported
Sitagliptin 100mg (Drug Naive)	18 of 223 (8.1%)	116 of 223 (52%)	Not reported
Empagliflozin 10 mg (Pioglitazone)	11 of 165 (6.7%)	110 of 165 (66.7%)	Not reported
Empagliflozin 25 mg (Pioglitazone)	13 of 165 (7.9%)	96 of 165 (58.2%)	Not reported
Placebo (Pioglitazone)	15 of 168 (8.9%)	107 of 168 (63.7%)	Not reported
Empagliflozin 10 mg (Metformin)	24 of 206 (11.7%)	122 of 206 (59.2%)	Not reported
Empagliflozin 25 mg (Metformin)	19 of 217 (8.8%)	113 of 217 (52.1%)	Not reported
Placebo (Metformin)	17 of 214 (7.9%)	106 of 214 (49.5%)	Not reported
Empagliflozin 10 mg (Metformin+Sulfonylurea)	31 of 225 (13.8%)	146 of 225 (64.9%)	Not reported
Empagliflozin 25 mg (Metformin+Sulfonylurea)	29 of 224 (12.9%)	147 of 224 (65.6%)	Not reported
Placebo (Metformin+Sulfonylurea)	24 of 217 (11.1%)	142 of 217 (65.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35472672Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
Derived from this study: PubMed 33084149Inzucchi SE, Davies MJ, Khunti K, Trivedi P, George JT, Zwiener I, Johansen OE, Sattar N. Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Feb;23(2):425-433. doi: 10.1111/dom.14234. Epub 2020 Nov 20.
Derived from this study: PubMed 28753486Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.
Derived from this study: PubMed 26701110Roden M, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Stella P, Woerle HJ, Broedl UC; EMPA-REG EXTEND MONO investigators. Safety, tolerability and effects on cardiometabolic risk factors of empagliflozin monotherapy in drug-naive patients with type 2 diabetes: a double-blind extension of a Phase III randomized controlled trial. Cardiovasc Diabetol. 2015 Dec 23;14:154. doi: 10.1186/s12933-015-0314-0.
Derived from this study: PubMed 26324220Haering HU, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Meinicke T, Woerle HJ, Broedl UC; EMPA-REG EXTEND METSU investigators. Empagliflozin as add-on to metformin plus sulphonylurea in patients with type 2 diabetes. Diabetes Res Clin Pract. 2015 Oct;110(1):82-90. doi: 10.1016/j.diabres.2015.05.044. Epub 2015 May 29.
Related InfoLink 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

243 sites in 19 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 Sitagliptin 100mg in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 243 sites in 19 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 2 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 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 243 sites in United States, Canada, China, Germany, India and 14 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. Some participants in this study may receive a placebo. 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 15 Jul 2014). 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?

Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment (time frame: Baseline and 52 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 NCT01289990, which also lists 5 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 15 Jul 2014; AzTrials last refreshed its copy on 8 Nov 2026.