Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes
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
2 other identifiers
interventional
2,705
18 countries
240
Brief Summary
This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Feb 2011
Typical duration for phase_3 diabetes-mellitus-type-2
240 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedFirst Posted
Study publicly available on registry
February 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
July 15, 2014
CompletedJuly 15, 2014
July 1, 2014
2.2 years
January 31, 2011
May 16, 2014
July 14, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Change from baseline in HbA1c after 52 weeks
Baseline and 52 weeks
Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Change from baseline in HbA1c after 76 weeks
Baseline and 76 weeks
Secondary Outcomes (11)
HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Baseline and 76 weeks
Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Baseline and 52 weeks
Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Baseline and 76 weeks
Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Baseline and 52 weeks
Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Baseline and 76 weeks
- +6 more secondary outcomes
Study Arms (13)
BI 10773 low (drug naive)
EXPERIMENTALBI 10773 tablets once daily
BI 10773 high (drug naive)
EXPERIMENTALBI 10773 tablets once daily
Placebo (drug naive)
PLACEBO COMPARATORPlacebo tablets matching BI 10773 / Sitagliptin once daily
Sitagliptin 100mg (drug naive)
ACTIVE COMPARATORSitagliptin once daily
BI 10773 low (pioglitazone)
EXPERIMENTALBI 10773 tablets once daily
BI 10773 high (pioglitazone)
EXPERIMENTALBI 10773 tablets once daily
Placebo (pioglitazone)
PLACEBO COMPARATORPlacebo tablets matching BI 10773 once daily
BI 10773 low (metformin)
EXPERIMENTALBI 10773 tablets once daily
BI 10773 high (metformin)
EXPERIMENTALBI 10773 tablets once daily
Placebo (metformin)
PLACEBO COMPARATORPlacebo tablets matching BI 10773 once daily
BI 10773 low (metformin+sulfonylurea)
EXPERIMENTALBI 10773 tablets once daily
BI 10773 high (metformin+sulfonylurea)
EXPERIMENTALBI 10773 tablets once daily
Placebo (metformin+sulfonylurea)
PLACEBO COMPARATORPlacebo tablets matching BI 10773
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boehringer Ingelheimlead
- Eli Lilly and Companycollaborator
Study Sites (243)
1245.31.10145 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1245.31.10162 Boehringer Ingelheim Investigational Site
Glendale, Arizona, United States
1245.31.10124 Boehringer Ingelheim Investigational Site
Mesa, Arizona, United States
1245.31.10108 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
1245.31.10046 Boehringer Ingelheim Investigational Site
Tempe, Arizona, United States
1245.31.10154 Boehringer Ingelheim Investigational Site
Chino, California, United States
1245.31.10149 Boehringer Ingelheim Investigational Site
Rancho Cucamonga, California, United States
1245.31.10131 Boehringer Ingelheim Investigational Site
West Hills, California, United States
1245.31.10038 Boehringer Ingelheim Investigational Site
Northglenn, Colorado, United States
1245.31.10127 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut, United States
1245.31.10137 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
1245.31.10133 Boehringer Ingelheim Investigational Site
Jupiter, Florida, United States
1245.31.10006 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1245.31.10085 Boehringer Ingelheim Investigational Site
Plantation, Florida, United States
1245.31.10080 Boehringer Ingelheim Investigational Site
Decatur, Georgia, United States
1245.31.10077 Boehringer Ingelheim Investigational Site
Perry, Georgia, United States
1245.31.10001 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
1245.31.10159 Boehringer Ingelheim Investigational Site
Des Moines, Iowa, United States
1245.31.10014 Boehringer Ingelheim Investigational Site
Dubuque, Iowa, United States
1245.31.10117 Boehringer Ingelheim Investigational Site
Arkansas City, Kansas, United States
1245.31.10157 Boehringer Ingelheim Investigational Site
Newton, Kansas, United States
1245.31.10146 Boehringer Ingelheim Investigational Site
Louisville, Kentucky, United States
1245.31.10003 Boehringer Ingelheim Investigational Site
Dearborn, Michigan, United States
1245.31.10059 Boehringer Ingelheim Investigational Site
New Hyde Park, New York, United States
1245.31.10034 Boehringer Ingelheim Investigational Site
Rochester, New York, United States
1245.31.10123 Boehringer Ingelheim Investigational Site
Smithtown, New York, United States
1245.31.10071 Boehringer Ingelheim Investigational Site
Asheboro, North Carolina, United States
1245.31.10086 Boehringer Ingelheim Investigational Site
Salisbury, North Carolina, United States
1245.31.10129 Boehringer Ingelheim Investigational Site
Carlisle, Ohio, United States
1245.31.10045 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1245.31.10119 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1245.31.10130 Boehringer Ingelheim Investigational Site
Gallipolis, Ohio, United States
1245.31.10158 Boehringer Ingelheim Investigational Site
Mt. Pleasant, South Carolina, United States
1245.31.10015 Boehringer Ingelheim Investigational Site
Simpsonville, South Carolina, United States
1245.31.10033 Boehringer Ingelheim Investigational Site
Chattanooga, Tennessee, United States
1245.31.10112 Boehringer Ingelheim Investigational Site
Memphis, Tennessee, United States
1245.31.10156 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1245.31.10151 Boehringer Ingelheim Investigational Site
Hurst, Texas, United States
1245.31.10143 Boehringer Ingelheim Investigational Site
Killeen, Texas, United States
1245.31.10155 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
1245.31.32008 Boehringer Ingelheim Investigational Site
Brussels, Belgium
1245.31.32023 Boehringer Ingelheim Investigational Site
Brussels, Belgium
1245.31.32003 Boehringer Ingelheim Investigational Site
De Pinte, Belgium
1245.31.32015 Boehringer Ingelheim Investigational Site
Deurne, Belgium
1245.31.32016 Boehringer Ingelheim Investigational Site
Deurne, Belgium
1245.31.32025 Boehringer Ingelheim Investigational Site
Gozée, Belgium
1245.31.32019 Boehringer Ingelheim Investigational Site
Leopoldsburg, Belgium
1245.31.32024 Boehringer Ingelheim Investigational Site
Linkebeek, Belgium
1245.31.32021 Boehringer Ingelheim Investigational Site
Mouscron, Belgium
1245.31.32020 Boehringer Ingelheim Investigational Site
Sint-Gillis-Waas, Belgium
1245.31.32018 Boehringer Ingelheim Investigational Site
Tielt, Belgium
1245.31.32026 Boehringer Ingelheim Investigational Site
Tremelo, Belgium
1245.31.20032 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
1245.31.20023 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
1245.31.20011 Boehringer Ingelheim Investigational Site
Chilliwack, British Columbia, Canada
1245.31.20028 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1245.31.20018 Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada
1245.31.20033 Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada
1245.31.20015 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba, Canada
1245.31.20012 Boehringer Ingelheim Investigational Site
Moncton, New Brunswick, Canada
1245.31.20016 Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador, Canada
1245.31.20024 Boehringer Ingelheim Investigational Site
Paradise, Newfoundland and Labrador, Canada
1245.31.20008 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador, Canada
1245.31.20026 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia, Canada
1245.31.20022 Boehringer Ingelheim Investigational Site
Brampton, Ontario, Canada
1245.31.20057 Boehringer Ingelheim Investigational Site
Brampton, Ontario, Canada
1245.31.20035 Boehringer Ingelheim Investigational Site
Corunna, Ontario, Canada
1245.31.20030 Boehringer Ingelheim Investigational Site
Etobicoke, Ontario, Canada
1245.31.20019 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1245.31.20017 Boehringer Ingelheim Investigational Site
London, Ontario, Canada
1245.31.20029 Boehringer Ingelheim Investigational Site
London, Ontario, Canada
1245.31.20060 Boehringer Ingelheim Investigational Site
London, Ontario, Canada
1245.31.20003 Boehringer Ingelheim Investigational Site
Markham, Ontario, Canada
1245.31.20009 Boehringer Ingelheim Investigational Site
Newmarket, Ontario, Canada
1245.31.20040 Boehringer Ingelheim Investigational Site
Oakville, Ontario, Canada
1245.31.20034 Boehringer Ingelheim Investigational Site
Sarnia, Ontario, Canada
1245.31.20005 Boehringer Ingelheim Investigational Site
Strathroy, Ontario, Canada
1245.31.20002 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1245.31.20006 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1245.31.20007 Boehringer Ingelheim Investigational Site
Montague, Prince Edward Island, Canada
1245.31.20027 Boehringer Ingelheim Investigational Site
Laval, Quebec, Canada
1245.31.20025 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1245.31.20058 Boehringer Ingelheim Investigational Site
Saint Romuald, Quebec, Canada
1245.31.20038 Boehringer Ingelheim Investigational Site
Saint-Laurent, Quebec, Canada
1245.31.20036 Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec, Canada
1245.31.20021 Boehringer Ingelheim Investigational Site
Trois-Rivières, Quebec, Canada
1245.31.20041 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
1245.31.86007 Boehringer Ingelheim Investigational Site
Beijing, China
1245.31.86008 Boehringer Ingelheim Investigational Site
Beijing, China
1245.31.86031 Boehringer Ingelheim Investigational Site
Beijing, China
1245.31.86032 Boehringer Ingelheim Investigational Site
Beijing, China
1245.31.86033 Boehringer Ingelheim Investigational Site
Beijing, China
1245.31.86034 Boehringer Ingelheim Investigational Site
Beijing, China
1245.31.86035 Boehringer Ingelheim Investigational Site
Beijing, China
1245.31.86058 Boehringer Ingelheim Investigational Site
Chongqing, China
1245.31.86038 Boehringer Ingelheim Investigational Site
Dalian, China
1245.31.86001 Boehringer Ingelheim Investigational Site
Guangzhou, China
1245.31.86003 Boehringer Ingelheim Investigational Site
Guangzhou, China
1245.31.86052 Boehringer Ingelheim Investigational Site
Guangzhou, China
1245.31.86012 Boehringer Ingelheim Investigational Site
Guiyang, China
1245.31.86037 Boehringer Ingelheim Investigational Site
Haerbin, China
1245.31.86020 Boehringer Ingelheim Investigational Site
Hangzhou, China
1245.31.86049 Boehringer Ingelheim Investigational Site
Jinan, China
1245.31.86053 Boehringer Ingelheim Investigational Site
Jinan, China
1245.31.86018 Boehringer Ingelheim Investigational Site
Jingzhou, China
1245.31.86019 Boehringer Ingelheim Investigational Site
Nanchang, China
1245.31.86042 Boehringer Ingelheim Investigational Site
Nanjing, China
1245.31.86043 Boehringer Ingelheim Investigational Site
Nanjing, China
1245.31.86055 Boehringer Ingelheim Investigational Site
Nanning, China
1245.31.86056 Boehringer Ingelheim Investigational Site
Nanning, China
1245.31.86016 Boehringer Ingelheim Investigational Site
Qingdao, China
1245.31.86039 Boehringer Ingelheim Investigational Site
Shanghai, China
1245.31.86054 Boehringer Ingelheim Investigational Site
Shantou, China
1245.31.86057 Boehringer Ingelheim Investigational Site
Shenyang, China
1245.31.86045 Boehringer Ingelheim Investigational Site
Shijiazhuang, China
1245.31.86017 Boehringer Ingelheim Investigational Site
Shiyan, China
1245.31.86013 Boehringer Ingelheim Investigational Site
Suzhou, China
1245.31.86015 Boehringer Ingelheim Investigational Site
Taiyuan, China
1245.31.86036 Boehringer Ingelheim Investigational Site
Tianjin, China
1245.31.86011 Boehringer Ingelheim Investigational Site
Xi'an, China
1245.31.86041 Boehringer Ingelheim Investigational Site
Xi'an, China
1245.31.86014 Boehringer Ingelheim Investigational Site
Xiamen, China
1245.31.33008 Boehringer Ingelheim Investigational Site
Bersée, France
1245.31.33020 Boehringer Ingelheim Investigational Site
Bischheim, France
1245.31.33002 Boehringer Ingelheim Investigational Site
Bondy, France
1245.31.33016 Boehringer Ingelheim Investigational Site
Bruay-la-Buissière, France
1245.31.33001 Boehringer Ingelheim Investigational Site
Corbeil-Essonnes, France
1245.31.33010 Boehringer Ingelheim Investigational Site
Croix, France
1245.31.33009 Boehringer Ingelheim Investigational Site
Hautmont, France
1245.31.33003 Boehringer Ingelheim Investigational Site
La Rochelle, France
1245.31.33045 Boehringer Ingelheim Investigational Site
Marseille, France
1245.31.33004 Boehringer Ingelheim Investigational Site
Narbonne, France
1245.31.33012 Boehringer Ingelheim Investigational Site
Schiltigheim, France
1245.31.33013 Boehringer Ingelheim Investigational Site
Strasbourg, France
1245.31.33019 Boehringer Ingelheim Investigational Site
Strasbourg, France
1245.31.33007 Boehringer Ingelheim Investigational Site
Vieux-Condé, France
1245.31.33018 Boehringer Ingelheim Investigational Site
Wattrelos, France
1245.31.49001 Boehringer Ingelheim Investigational Site
Dormagen, Germany
1245.31.49013 Boehringer Ingelheim Investigational Site
Dresden, Germany
1245.31.49016 Boehringer Ingelheim Investigational Site
Düsseldorf, Germany
1245.31.49009 Boehringer Ingelheim Investigational Site
Flörsheim, Germany
1245.31.49015 Boehringer Ingelheim Investigational Site
Frankfurt, Germany
1245.31.49019 Boehringer Ingelheim Investigational Site
Haag, Germany
1245.31.49004 Boehringer Ingelheim Investigational Site
Hatten, Germany
1245.31.49020 Boehringer Ingelheim Investigational Site
Hohenmölsen, Germany
1245.31.49007 Boehringer Ingelheim Investigational Site
Künzing, Germany
1245.31.49002 Boehringer Ingelheim Investigational Site
Neuwied, Germany
1245.31.49008 Boehringer Ingelheim Investigational Site
Nuremberg, Germany
1245.31.49010 Boehringer Ingelheim Investigational Site
Rednitzhembach, Germany
1245.31.49006 Boehringer Ingelheim Investigational Site
Rehburg-Loccum, Germany
1245.31.49011 Boehringer Ingelheim Investigational Site
Rehlingen-Siersburg, Germany
1245.31.49005 Boehringer Ingelheim Investigational Site
Saarbrücken, Germany
1245.31.49017 Boehringer Ingelheim Investigational Site
Saint Ingbert/Oberwürzbach, Germany
1245.31.49022 Boehringer Ingelheim Investigational Site
Schauenburg, Germany
1245.31.49003 Boehringer Ingelheim Investigational Site
Unterschneidheim, Germany
1245.31.30004 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
1245.31.91005 Boehringer Ingelheim Investigational Site
Bangalore, India
1245.31.91006 Boehringer Ingelheim Investigational Site
Bangalore, India
1245.31.91008 Boehringer Ingelheim Investigational Site
Bangalore, India
1245.31.91003 Boehringer Ingelheim Investigational Site
Belagavi, India
1245.31.91004 Boehringer Ingelheim Investigational Site
Chennai, India
1245.31.91009 Boehringer Ingelheim Investigational Site
Chennai, India
1245.31.91001 Boehringer Ingelheim Investigational Site
Coimbatore, India
1245.31.91101 Boehringer Ingelheim Investigational Site
Coimbatore, India
1245.31.91104 Boehringer Ingelheim Investigational Site
Indore, India
1245.31.91015 Boehringer Ingelheim Investigational Site
Kalaburagi, India
1245.31.91103 Boehringer Ingelheim Investigational Site
Maharashtra, India
1245.31.91002 Boehringer Ingelheim Investigational Site
Mumbai, India
1245.31.91007 Boehringer Ingelheim Investigational Site
Mumbai, Maharastra, India
1245.31.91010 Boehringer Ingelheim Investigational Site
Nagpur, India
1245.31.91012 Boehringer Ingelheim Investigational Site
New Delhi, India
1245.31.91014 Boehringer Ingelheim Investigational Site
Pune, India
1245.31.91105 Boehringer Ingelheim Investigational Site
Pune, India
1245.31.35304 Boehringer Ingelheim Investigational Site
Birr, Co. Offaly, Ireland
1245.31.35302 Boehringer Ingelheim Investigational Site
Co. Cork, Ireland
1245.31.35305 Boehringer Ingelheim Investigational Site
Co. Galway, Ireland
1245.31.35303 Boehringer Ingelheim Investigational Site
Co. Wexford, Ireland
1245.31.35306 Boehringer Ingelheim Investigational Site
Co. Wexford, Ireland
1245.31.81007 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo, Japan
1245.31.81001 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
1245.31.81002 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
1245.31.81005 Boehringer Ingelheim Investigational Site
Ebetsu, Hokkaido, Japan
1245.31.81004 Boehringer Ingelheim Investigational Site
Kamakura, Kanagawa, Japan
1245.31.81003 Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo, Japan
1245.31.81006 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1245.31.81008 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1245.31.81009 Boehringer Ingelheim Investigational Site
Suita, Osaka, Japan
1245.31.81010 Boehringer Ingelheim Investigational Site
Ube, Yamaguchi, Japan
1245.31.81012 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa, Japan
1245.31.81013 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa, Japan
1245.31.52003 Boehringer Ingelheim Investigational Site
Guadalajara, Mexico
1245.31.52004 Boehringer Ingelheim Investigational Site
Guadalajara, Mexico
1245.31.52001 Boehringer Ingelheim Investigational Site
Monterrey, Mexico
1245.31.52002 Boehringer Ingelheim Investigational Site
Monterrey, Mexico
1245.31.63002 Boehringer Ingelheim Investigational Site
Cebu, Philippines
1245.31.63003 Boehringer Ingelheim Investigational Site
Davao City, Philippines
1245.31.63001 Boehringer Ingelheim Investigational Site
Manila, Philippines
1245.31.63004 Boehringer Ingelheim Investigational Site
Manila, Philippines
1245.31.63005 Boehringer Ingelheim Investigational Site
Manila, Philippines
1245.31.74005 Boehringer Ingelheim Investigational Site
Bratislava, Slovakia
1245.31.74002 Boehringer Ingelheim Investigational Site
Lučenec, Slovakia
1245.31.74006 Boehringer Ingelheim Investigational Site
Nitra, Slovakia
1245.31.74014 Boehringer Ingelheim Investigational Site
Nové Zámky, Slovakia
1245.31.74001 Boehringer Ingelheim Investigational Site
Považská Bystrica, Slovakia
1245.31.74004 Boehringer Ingelheim Investigational Site
Prešov, Slovakia
1245.31.74003 Boehringer Ingelheim Investigational Site
Trebišov, Slovakia
1245.31.38003 Boehringer Ingelheim Investigational Site
Celje, Slovenia
1245.31.38002 Boehringer Ingelheim Investigational Site
Koper, Slovenia
1245.31.38001 Boehringer Ingelheim Investigational Site
Maribor, Slovenia
1245.31.82012 Boehringer Ingelheim Investigational Site
Anyang, South Korea
1245.31.82011 Boehringer Ingelheim Investigational Site
Goyang, South Korea
1245.31.82009 Boehringer Ingelheim Investigational Site
Ilsan, South Korea
1245.31.82001 Boehringer Ingelheim Investigational Site
Incheon, South Korea
1245.31.82006 Boehringer Ingelheim Investigational Site
Jeonju, South Korea
1245.31.82004 Boehringer Ingelheim Investigational Site
Pusan, South Korea
1245.31.82005 Boehringer Ingelheim Investigational Site
Seoul, South Korea
1245.31.82007 Boehringer Ingelheim Investigational Site
Seoul, South Korea
1245.31.82008 Boehringer Ingelheim Investigational Site
Seoul, South Korea
1245.31.82010 Boehringer Ingelheim Investigational Site
Seoul, South Korea
1245.31.82014 Boehringer Ingelheim Investigational Site
Seoul, South Korea
1245.31.82002 Boehringer Ingelheim Investigational Site
Suwon, South Korea
1245.31.82003 Boehringer Ingelheim Investigational Site
Wŏnju, South Korea
1245.31.41004 Boehringer Ingelheim Investigational Site
Lugano, Switzerland
1245.31.41003 Boehringer Ingelheim Investigational Site
Rorschach, Switzerland
1245.31.88010 Boehringer Ingelheim Investigational Site
Kaohsiung City, Taiwan
1245.31.88011 Boehringer Ingelheim Investigational Site
Kaohsiung City, Taiwan
1245.31.88012 Boehringer Ingelheim Investigational Site
Kaohsiung City, Taiwan
1245.31.88013 Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
1245.31.88009 Boehringer Ingelheim Investigational Site
Taichung, Taiwan
1245.31.88014 Boehringer Ingelheim Investigational Site
Tainan, Taiwan
1245.31.88006 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1245.31.88021 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1245.31.88008 Boehringer Ingelheim Investigational Site
Taoyuan, Taiwan
1245.31.90003 Boehringer Ingelheim Investigational Site
Erzurum, Turkey (Türkiye)
1245.31.90001 Boehringer Ingelheim Investigational Site
Gaziantep, Turkey (Türkiye)
1245.31.90002 Boehringer Ingelheim Investigational Site
Istanbul, Turkey (Türkiye)
1245.31.90006 Boehringer Ingelheim Investigational Site
Istanbul, Turkey (Türkiye)
1245.31.90004 Boehringer Ingelheim Investigational Site
Izmir, Turkey (Türkiye)
1245.31.75002 Boehringer Ingelheim Investigational Site
Dnipro, Ukraine
1245.31.75001 Boehringer Ingelheim Investigational Site
Kharkiv, Ukraine
1245.31.75006 Boehringer Ingelheim Investigational Site
Lviv, Ukraine
1245.31.75004 Boehringer Ingelheim Investigational Site
Vinnitsa, Ukraine
1245.31.75003 Boehringer Ingelheim Investigational Site
Vinnytsia, Ukraine
Related Publications (5)
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.
PMID: 35472672DERIVEDInzucchi 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.
PMID: 33084149DERIVEDShiba 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.
PMID: 28753486DERIVEDRoden 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.
PMID: 26701110DERIVEDHaering 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.
PMID: 26324220DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2011
First Posted
February 4, 2011
Study Start
February 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
July 15, 2014
Results First Posted
July 15, 2014
Record last verified: 2014-07