Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4467
Source ID: NCT01177813
Associated Drug: Placebo Identical To Bi10773 High Dose
Title: Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01177813/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Placebo identical to BI10773 high dose|DRUG: BI 10773|DRUG: BI 10773 open label|DRUG: Placebo identical to BI10773 low dose|DRUG: Placebo identical to BI10773 low dose|DRUG: Placebo identical to BI10773 high dose|DRUG: Placebo identical to Sitagliptin 100mg|DRUG: Placebo identical to Sitagliptin 100mg|DRUG: BI10773|DRUG: Sitagliptin|DRUG: Placebo identical to Sitagliptin 100mg|DRUG: Placebo identical to BI10773 low dose|DRUG: Placebo identical to BI10773 high dose
Outcome Measures: Primary: Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks, The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive., Baseline and day 169 | Secondary: Change From Baseline to Week 24 in Body Weight, The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive., Baseline and day 169|Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP), The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive. For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored., Baseline and week 24 | Other: Confirmed Hypoglycaemic Adverse Events, Confirmed hypoglycaemic events refer to all hypoglycaemic events, that had a glucose value \<= 70 ml/dL or where assistance was required. Symptomatic hypoglycaemic events were to be reported as adverse events. Patients can be counted in more than one category., From first drug intake until 7 days after last medication intake, up to 219 days
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 986
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2010-07
Completion Date:
Results First Posted: 2014-06-16
Last Update Posted: 2014-06-16
Locations: 1245.20.10124 Boehringer Ingelheim Investigational Site, Mesa, Arizona, United States|1245.20.10108 Boehringer Ingelheim Investigational Site, Phoenix, Arizona, United States|1245.20.10150 Boehringer Ingelheim Investigational Site, Hot Springs, Arkansas, United States|1245.20.10154 Boehringer Ingelheim Investigational Site, Chino, California, United States|1245.20.10009 Boehringer Ingelheim Investigational Site, Santa Ana, California, United States|1245.20.10131 Boehringer Ingelheim Investigational Site, West Hills, California, United States|1245.20.10038 Boehringer Ingelheim Investigational Site, Northglenn, Colorado, United States|1245.20.10137 Boehringer Ingelheim Investigational Site, Clearwater, Florida, United States|1245.20.10006 Boehringer Ingelheim Investigational Site, Miami, Florida, United States|1245.20.10085 Boehringer Ingelheim Investigational Site, Plantation, Florida, United States|1245.20.10078 Boehringer Ingelheim Investigational Site, Tampa, Florida, United States|1245.20.10080 Boehringer Ingelheim Investigational Site, Decatur, Georgia, United States|1245.20.10128 Boehringer Ingelheim Investigational Site, Avon, Indiana, United States|1245.20.10060 Boehringer Ingelheim Investigational Site, Fishers, Indiana, United States|1245.20.10065 Boehringer Ingelheim Investigational Site, Indianapolis, Indiana, United States|1245.20.10117 Boehringer Ingelheim Investigational Site, Arkansas City, Kansas, United States|1245.20.10039 Boehringer Ingelheim Investigational Site, Wichita, Kansas, United States|1245.20.10146 Boehringer Ingelheim Investigational Site, Louisville, Kentucky, United States|1245.20.10144 Boehringer Ingelheim Investigational Site, Watertown, Massachusetts, United States|1245.20.10115 Boehringer Ingelheim Investigational Site, Brick, New Jersey, United States|1245.20.10129 Boehringer Ingelheim Investigational Site, Carlisle, Ohio, United States|1245.20.10045 Boehringer Ingelheim Investigational Site, Cincinnati, Ohio, United States|1245.20.10119 Boehringer Ingelheim Investigational Site, Cincinnati, Ohio, United States|1245.20.10130 Boehringer Ingelheim Investigational Site, Gallipolis, Ohio, United States|1245.20.10089 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1245.20.10151 Boehringer Ingelheim Investigational Site, Hurst, Texas, United States|1245.20.10155 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States|1245.20.32008 Boehringer Ingelheim Investigational Site, Bruxelles, Belgium|1245.20.32011 Boehringer Ingelheim Investigational Site, Bruxelles, Belgium|1245.20.32023 Boehringer Ingelheim Investigational Site, Bruxelles, Belgium|1245.20.32003 Boehringer Ingelheim Investigational Site, De Pinte, Belgium|1245.20.32015 Boehringer Ingelheim Investigational Site, Deurne, Belgium|1245.20.32016 Boehringer Ingelheim Investigational Site, Deurne, Belgium|1245.20.32025 Boehringer Ingelheim Investigational Site, Gozée, Belgium|1245.20.32022 Boehringer Ingelheim Investigational Site, Landen, Belgium|1245.20.32019 Boehringer Ingelheim Investigational Site, Leopoldsburg, Belgium|1245.20.32024 Boehringer Ingelheim Investigational Site, Linkebeek, Belgium|1245.20.32021 Boehringer Ingelheim Investigational Site, Mouscron, Belgium|1245.20.32027 Boehringer Ingelheim Investigational Site, Retie, Belgium|1245.20.32020 Boehringer Ingelheim Investigational Site, Sint-Gillis-Waas, Belgium|1245.20.32018 Boehringer Ingelheim Investigational Site, Tielt, Belgium|1245.20.32026 Boehringer Ingelheim Investigational Site, Tremelo, Belgium|1245.20.20011 Boehringer Ingelheim Investigational Site, Chilliwack, British Columbia, Canada|1245.20.20018 Boehringer Ingelheim Investigational Site, Victoria, British Columbia, Canada|1245.20.20015 Boehringer Ingelheim Investigational Site, Winnipeg, Manitoba, Canada|1245.20.20012 Boehringer Ingelheim Investigational Site, Moncton, New Brunswick, Canada|1245.20.20016 Boehringer Ingelheim Investigational Site, Mount Pearl, Newfoundland and Labrador, Canada|1245.20.20008 Boehringer Ingelheim Investigational Site, St. John's, Newfoundland and Labrador, Canada|1245.20.20001 Boehringer Ingelheim Investigational Site, Barrie, Ontario, Canada|1245.20.20019 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada|1245.20.20010 Boehringer Ingelheim Investigational Site, London, Ontario, Canada|1245.20.20017 Boehringer Ingelheim Investigational Site, London, Ontario, Canada|1245.20.20003 Boehringer Ingelheim Investigational Site, Markham, Ontario, Canada|1245.20.20009 Boehringer Ingelheim Investigational Site, Newmarket, Ontario, Canada|1245.20.20013 Boehringer Ingelheim Investigational Site, Ottawa, Ontario, Canada|1245.20.20005 Boehringer Ingelheim Investigational Site, Strathroy, Ontario, Canada|1245.20.20002 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada|1245.20.20006 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada|1245.20.20014 Boehringer Ingelheim Investigational Site, Charlottetown, Prince Edward Island, Canada|1245.20.20007 Boehringer Ingelheim Investigational Site, Montague, Prince Edward Island, Canada|1245.20.20021 Boehringer Ingelheim Investigational Site, Trois Rivieres, Quebec, Canada|1245.20.86007 Boehringer Ingelheim Investigational Site, Beijing, China|1245.20.86008 Boehringer Ingelheim Investigational Site, Beijing, China|1245.20.86001 Boehringer Ingelheim Investigational Site, Guangzhou, China|1245.20.86002 Boehringer Ingelheim Investigational Site, Guangzhou, China|1245.20.86003 Boehringer Ingelheim Investigational Site, Guangzhou, China|1245.20.86012 Boehringer Ingelheim Investigational Site, Guiyang, China|1245.20.86020 Boehringer Ingelheim Investigational Site, Hangzhou, China|1245.20.86049 Boehringer Ingelheim Investigational Site, Jinan, China|1245.20.86018 Boehringer Ingelheim Investigational Site, Jingzhou, China|1245.20.86019 Boehringer Ingelheim Investigational Site, Nanchang, China|1245.20.86010 Boehringer Ingelheim Investigational Site, Nanjing, China|1245.20.86043 Boehringer Ingelheim Investigational Site, Nanjing, China|1245.20.86016 Boehringer Ingelheim Investigational Site, QingDao, China|1245.20.86004 Boehringer Ingelheim Investigational Site, Shanghai, China|1245.20.86005 Boehringer Ingelheim Investigational Site, Shanghai, China|1245.20.86006 Boehringer Ingelheim Investigational Site, Shanghai, China|1245.20.86057 Boehringer Ingelheim Investigational Site, Shenyang, China|1245.20.86017 Boehringer Ingelheim Investigational Site, Shiyan, China|1245.20.86013 Boehringer Ingelheim Investigational Site, Suzhou, China|1245.20.86015 Boehringer Ingelheim Investigational Site, Taiyuan, China|1245.20.86009 Boehringer Ingelheim Investigational Site, Wuhan, China|1245.20.86011 Boehringer Ingelheim Investigational Site, Xi'An, China|1245.20.86014 Boehringer Ingelheim Investigational Site, Xiamen, China|1245.20.49013 Boehringer Ingelheim Investigational Site, Dresden, Germany|1245.20.49016 Boehringer Ingelheim Investigational Site, Düsseldorf, Germany|1245.20.49015 Boehringer Ingelheim Investigational Site, Frankfurt, Germany|1245.20.49019 Boehringer Ingelheim Investigational Site, Haag, Germany|1245.20.49020 Boehringer Ingelheim Investigational Site, Hohenmölsen, Germany|1245.20.49014 Boehringer Ingelheim Investigational Site, Köthen, Germany|1245.20.49002 Boehringer Ingelheim Investigational Site, Neuwied, Germany|1245.20.49008 Boehringer Ingelheim Investigational Site, Nürnberg, Germany|1245.20.49022 Boehringer Ingelheim Investigational Site, Schauenburg, Germany|1245.20.49017 Boehringer Ingelheim Investigational Site, St. Ingbert/Oberwürzbach, Germany|1245.20.49003 Boehringer Ingelheim Investigational Site, Unterschneidheim, Germany|1245.20.91005 Boehringer Ingelheim Investigational Site, Bangalore, India|1245.20.91006 Boehringer Ingelheim Investigational Site, Bangalore, India|1245.20.91008 Boehringer Ingelheim Investigational Site, Bangalore, India|1245.20.91003 Boehringer Ingelheim Investigational Site, Belgaum, India|1245.20.91004 Boehringer Ingelheim Investigational Site, Chennai, India|1245.20.91009 Boehringer Ingelheim Investigational Site, Chennai, India|1245.20.91007 Boehringer Ingelheim Investigational Site, Mumbai, Maharastra, India|1245.20.91002 Boehringer Ingelheim Investigational Site, Mumbai, India|1245.20.91010 Boehringer Ingelheim Investigational Site, Nagpur, India|1245.20.91001 Boehringer Ingelheim Investigational Site, Tamil Nadu, India|1245.20.35302 Boehringer Ingelheim Investigational Site, Co. Cork, Ireland|1245.20.35305 Boehringer Ingelheim Investigational Site, Co. Galway, Ireland|1245.20.35303 Boehringer Ingelheim Investigational Site, Co. Wexford, Ireland|1245.20.35304 Boehringer Ingelheim Investigational Site, Offaly, Ireland|1245.20.35306 Boehringer Ingelheim Investigational Site, Wexford, Ireland|1245.20.81007 Boehringer Ingelheim Investigational Site, Chiyoda-ku, Tokyo, Japan|1245.20.81001 Boehringer Ingelheim Investigational Site, Chuo-ku, Tokyo, Japan|1245.20.81002 Boehringer Ingelheim Investigational Site, Chuo-ku, Tokyo, Japan|1245.20.81005 Boehringer Ingelheim Investigational Site, Ebetsu, Hokkaido, Japan|1245.20.81004 Boehringer Ingelheim Investigational Site, Kamakura, Kanagawa, Japan|1245.20.81003 Boehringer Ingelheim Investigational Site, Minato-ku, Tokyo, Japan|1245.20.81006 Boehringer Ingelheim Investigational Site, Shinjuku-ku, Tokyo, Japan|1245.20.81008 Boehringer Ingelheim Investigational Site, Shinjuku-ku, Tokyo, Japan|1245.20.81009 Boehringer Ingelheim Investigational Site, Suita, Osaka, Japan|1245.20.81010 Boehringer Ingelheim Investigational Site, Ube, Yamaguchi, Japan|1245.20.81012 Boehringer Ingelheim Investigational Site, Urasoe, Okinawa, Japan|1245.20.81013 Boehringer Ingelheim Investigational Site, Urasoe, Okinawa, Japan|1245.20.41004 Boehringer Ingelheim Investigational Site, Lugano, Switzerland|1245.20.41003 Boehringer Ingelheim Investigational Site, Rorschach, Switzerland
URL: https://clinicaltrials.gov/show/NCT01177813

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress