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Clinical Trial Details

Trial ID: L3525
Source ID: NCT01210001
Associated Drug: Placebo
Title: Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01210001/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Placebo|DRUG: BI 10773|DRUG: Placebo|DRUG: Placebo|DRUG: Placebo|DRUG: BI 10773
Outcome Measures: Primary: HbA1c Change From Baseline, Change From Baseline in HbA1c after 24 weeks. Note that adjusted means are provided., Baseline and 24 weeks|HbA1c Change From Baseline for Pio and Met Background Medication Patients, Change From Baseline in HbA1c after 24 weeks for patients with pioglitazone (pio) and metformin (met) background medication only. Note that adjusted means are provided., Baseline and 24 weeks | Secondary: Fasting Plasma Glucose (FPG) Change From Baseline, Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment. Note that adjusted means are provided., Baseline and 24 weeks|Body Weight Change From Baseline, Change from baseline in body weight after 24 weeks. Note that adjusted means are provided., Baseline and 24 weeks | Other: Hypoglycaemic Events, Number of patients with hypoglycaemic events, as reported as adverse events., From first drug administration until 7 days after last intake of study drug, up to 256 days
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 499
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2010-09
Completion Date:
Results First Posted: 2014-06-17
Last Update Posted: 2014-06-17
Locations: 1245.19.10056 Boehringer Ingelheim Investigational Site, Muscle Shoals, Alabama, United States|1245.19.10162 Boehringer Ingelheim Investigational Site, Glendale, Arizona, United States|1245.19.10161 Boehringer Ingelheim Investigational Site, Phoenix, Arizona, United States|1245.19.10046 Boehringer Ingelheim Investigational Site, Tempe, Arizona, United States|1245.19.10070 Boehringer Ingelheim Investigational Site, Irvine, California, United States|1245.19.10047 Boehringer Ingelheim Investigational Site, La Mesa, California, United States|1245.19.10149 Boehringer Ingelheim Investigational Site, Rancho Cucamonga, California, United States|1245.19.10163 Boehringer Ingelheim Investigational Site, Riverside, California, United States|1245.19.10131 Boehringer Ingelheim Investigational Site, West Hills, California, United States|1245.19.10141 Boehringer Ingelheim Investigational Site, Milford, Connecticut, United States|1245.19.10133 Boehringer Ingelheim Investigational Site, Jupiter, Florida, United States|1245.19.10085 Boehringer Ingelheim Investigational Site, Plantation, Florida, United States|1245.19.10077 Boehringer Ingelheim Investigational Site, Perry, Georgia, United States|1245.19.10014 Boehringer Ingelheim Investigational Site, Dubuque, Iowa, United States|1245.19.10160 Boehringer Ingelheim Investigational Site, Essex, Maryland, United States|1245.19.10003 Boehringer Ingelheim Investigational Site, Dearborn, Michigan, United States|1245.19.10059 Boehringer Ingelheim Investigational Site, New Hyde Park, New York, United States|1245.19.10123 Boehringer Ingelheim Investigational Site, Smithtown, New York, United States|1245.19.10071 Boehringer Ingelheim Investigational Site, Asheboro, North Carolina, United States|1245.19.10086 Boehringer Ingelheim Investigational Site, Salisbury, North Carolina, United States|1245.19.10008 Boehringer Ingelheim Investigational Site, Marion, Ohio, United States|1245.19.10033 Boehringer Ingelheim Investigational Site, Chattanooga, Tennessee, United States|1245.19.10112 Boehringer Ingelheim Investigational Site, Memphis, Tennessee, United States|1245.19.10002 Boehringer Ingelheim Investigational Site, Norfolk, Virginia, United States|1245.19.20047 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada|1245.19.20062 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada|1245.19.20012 G.A. Research Associates Ltd., Moncton, New Brunswick, Canada|1245.19.20031 Boehringer Ingelheim Investigational Site, St. John's, Newfoundland and Labrador, Canada|1245.19.20057 Boehringer Ingelheim Investigational Site, Brampton, Ontario, Canada|1245.19.20059 Boehringer Ingelheim Investigational Site, Fort Erie, Ontario, Canada|1245.19.20060 Boehringer Ingelheim Investigational Site, London, Ontario, Canada|1245.19.20009 Boehringer Ingelheim Investigational Site, Newmarket, Ontario, Canada|1245.19.20034 Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada|1245.19.20058 Boehringer Ingelheim Investigational Site, St-Romuald, Quebec, Canada|1245.19.20041 Boehringer Ingelheim Investigational Site, Saskatoon, Saskatchewan, Canada|1245.19.30002 Boehringer Ingelheim Investigational Site, Athens, Greece|1245.19.30001 Boehringer Ingelheim Investigational Site, Nikaia, Greece|1245.19.30004 Boehringer Ingelheim Investigational Site, Thessaloniki, Greece|1245.19.91005 Boehringer Ingelheim Investigational Site, Bangalore, India|1245.19.91006 Boehringer Ingelheim Investigational Site, Bangalore, India|1245.19.91008 Boehringer Ingelheim Investigational Site, Bangalore, India|1245.19.91003 Boehringer Ingelheim Investigational Site, Belgaum, India|1245.19.91004 Boehringer Ingelheim Investigational Site, Chennai, India|1245.19.91009 Boehringer Ingelheim Investigational Site, Chennai, India|1245.19.91001 Boehringer Ingelheim Investigational Site, Coimbatore, India|1245.19.91015 Boehringer Ingelheim Investigational Site, Gulbarga, India|1245.19.91011 Boehringer Ingelheim Investigational Site, Kartanaka, India|1245.19.91007 Boehringer Ingelheim Investigational Site, Mumbai, Maharastra, India|1245.19.91002 Boehringer Ingelheim Investigational Site, Mumbai, India|1245.19.91017 Boehringer Ingelheim Investigational Site, Mysore, India|1245.19.91010 Boehringer Ingelheim Investigational Site, Nagpur, India|1245.19.91012 Boehringer Ingelheim Investigational Site, New Delhi, India|1245.19.91013 Boehringer Ingelheim Investigational Site, Patna, India|1245.19.91014 Boehringer Ingelheim Investigational Site, Pune, India|1245.19.91016 Boehringer Ingelheim Investigational Site, Pune, India|1245.19.63002 Boehringer Ingelheim Investigational Site, Cebu City, N/A, Philippines, Philippines|1245.19.63003 Boehringer Ingelheim Investigational Site, Davao City, N/A, Philippines, Philippines|1245.19.63004 Boehringer Ingelheim Investigational Site, Manila, Philippines, Philippines|1245.19.63005 Boehringer Ingelheim Investigational Site, Pasig City, Philippines, Philippines|1245.19.63001 Boehringer Ingelheim Investigational Site, San Juan City, Philippines, Philippines|1245.19.66003 Boehringer Ingelheim Investigational Site, Saimai, Thailand|1245.19.66004 Boehringer Ingelheim Investigational Site, Udon Thani, Thailand, Thailand|1245.19.75002 Boehringer Ingelheim Investigational Site, Dnepropetrovsk, Ukraine|1245.19.75001 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine|1245.19.75005 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1245.19.75006 Boehringer Ingelheim Investigational Site, Lviv, Ukraine|1245.19.75004 Boehringer Ingelheim Investigational Site, Vinnitsa, Ukraine|1245.19.75003 Boehringer Ingelheim Investigational Site, Vinnytsya, Ukraine
URL: https://clinicaltrials.gov/show/NCT01210001

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress