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Clinical Trial Details

Trial ID: L3716
Source ID: NCT01164501
Associated Drug: Bi 10773
Title: Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01164501/results
Conditions: Diabetes Mellitus, Type 2|Renal Insufficiency
Interventions: DRUG: BI 10773|DRUG: Placebo|DRUG: Placebo|DRUG: BI 10773|DRUG: Placebo|DRUG: Placebo
Outcome Measures: Primary: HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment, Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment. Note adjusted means are provided., Baseline and 24 weeks|HbA1c Change From Baseline in Patients With Mild Renal Impairment, Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment. Note adjusted means are provided., Baseline and 24 weeks|HbA1c Change From Baseline in Patients With Moderate Renal Impairment, Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment. Note adjusted means are provided., Baseline and 24 weeks | Other: Hypoglycaemic Events, Percentage of patients who experienced a hypoglycaemic event. A hypoglycaemic event was regarded as confirmed if it was documented as an adverse event with plasma glucose values \<= 70 mg/dL (\<=3.9mmol/L) measured or with a documentation that the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative action had been required., From first drug administration until 7 days after last trial medication intake, up to 458 days
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 741
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2010-07
Completion Date: 2012-07
Results First Posted: 2014-06-16
Last Update Posted: 2014-06-16
Locations: 1245.36.10014 Boehringer Ingelheim Investigational Site, Anaheim, California, United States|1245.36.10019 Boehringer Ingelheim Investigational Site, Lomita, California, United States|1245.36.10017 Boehringer Ingelheim Investigational Site, Plantation, Florida, United States|1245.36.10009 Boehringer Ingelheim Investigational Site, West Palm Beach, Florida, United States|1245.36.10018 Boehringer Ingelheim Investigational Site, Honolulu, Hawaii, United States|1245.36.10015 Boehringer Ingelheim Investigational Site, Shreveport, Louisiana, United States|1245.36.10021 Boehringer Ingelheim Investigational Site, Endwell, New York, United States|1245.36.10008 Boehringer Ingelheim Investigational Site, Greenville, North Carolina, United States|1245.36.10005 Boehringer Ingelheim Investigational Site, Bethlehem, Pennsylvania, United States|1245.36.10003 Boehringer Ingelheim Investigational Site, Melrose Park, Pennsylvania, United States|1245.36.10004 Boehringer Ingelheim Investigational Site, Greer, South Carolina, United States|1245.36.10012 Boehringer Ingelheim Investigational Site, Corpus Christi, Texas, United States|1245.36.10013 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States|1245.36.10002 Boehringer Ingelheim Investigational Site, Houston, Texas, United States|1245.36.10007 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States|1245.36.10023 Boehringer Ingelheim Investigational Site, Renton, Washington, United States|1245.36.10011 Boehringer Ingelheim Investigational Site, Spokane, Washington, United States|1245.36.10006 Boehringer Ingelheim Investigational Site, Tacoma, Washington, United States|1245.36.20052 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada|1245.36.20054 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada|1245.36.20023 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada|1245.36.20055 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada|1245.36.20048 Boehringer Ingelheim Investigational Site, Winnipeg, Manitoba, Canada|1245.36.20051 Boehringer Ingelheim Investigational Site, Mississauga, Ontario, Canada|1245.36.20086 Boehringer Ingelheim Investigational Site, Thornhill, Ontario, Canada|1245.36.20053 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada|1245.36.20056 Boehringer Ingelheim Investigational Site, Montreal, Quebec, Canada|1245.36.33001 Boehringer Ingelheim Investigational Site, Corbeil Essonnes, France|1245.36.33042 Boehringer Ingelheim Investigational Site, Nanterre Cedex, France|1245.36.33041 Boehringer Ingelheim Investigational Site, Nice, France|1245.36.33036 Boehringer Ingelheim Investigational Site, Paris, France|1245.36.33040 Boehringer Ingelheim Investigational Site, Poitiers, France|1245.36.33038 Boehringer Ingelheim Investigational Site, Reims Cedex, France|1245.36.33037 Boehringer Ingelheim Investigational Site, Reims, France|1245.36.33043 Boehringer Ingelheim Investigational Site, Rennes, France|1245.36.33044 Boehringer Ingelheim Investigational Site, Saint Mandé, France|1245.36.85201 Boehringer Ingelheim Investigational Site, Hong Kong, Hong Kong|1245.36.85204 Boehringer Ingelheim Investigational Site, Hong Kong, Hong Kong|1245.36.85205 Boehringer Ingelheim Investigational Site, Hong Kong, Hong Kong|1245.36.85206 Boehringer Ingelheim Investigational Site, Hong Kong, Hong Kong|1245.36.85202 Boehringer Ingelheim Investigational Site, Kowloon, Hong Kong|1245.36.91209 Boehringer Ingelheim Investigational Site, Aligarh, Uttar Pradesh, India|1245.36.91202 Boehringer Ingelheim Investigational Site, Bangalore, India|1245.36.91204 Boehringer Ingelheim Investigational Site, Bangalore, India|1245.36.91205 Boehringer Ingelheim Investigational Site, Bangalore, India|1245.36.91208 Boehringer Ingelheim Investigational Site, Bangalore, India|1245.36.91201 Boehringer Ingelheim Investigational Site, Chennai, India|1245.36.91214 Boehringer Ingelheim Investigational Site, Chennai, India|1245.36.91213 Boehringer Ingelheim Investigational Site, Gurgaon, India|1245.36.91203 Boehringer Ingelheim Investigational Site, Hyderabad, India|1245.36.91211 Boehringer Ingelheim Investigational Site, Kolkata, India|1245.36.91210 Boehringer Ingelheim Investigational Site, Mangalore, India|1245.36.91215 Boehringer Ingelheim Investigational Site, Mumbai, Maharastra, India|1245.36.91216 Boehringer Ingelheim Investigational Site, Nasik, India|1245.36.91212 Boehringer Ingelheim Investigational Site, New Delhi, India|1245.36.91207 Boehringer Ingelheim Investigational Site, Pune, India|1245.36.60003 Boehringer Ingelheim Investigational Site, Johor Baru, Malaysia|1245.36.60006 Boehringer Ingelheim Investigational Site, Kelantan Kota Bahru, Malaysia|1245.36.60005 Boehringer Ingelheim Investigational Site, Kuala Lumpur, Malaysia|1245.36.60009 Boehringer Ingelheim Investigational Site, Kuala Lumpur, Malaysia|1245.36.60004 Boehringer Ingelheim Investigational Site, Pahang, Malaysia|1245.36.60007 Boehringer Ingelheim Investigational Site, Perak, Malaysia|1245.36.60011 Boehringer Ingelheim Investigational Site, Perak, Malaysia|1245.36.60010 Boehringer Ingelheim Investigational Site, Pulau Piang, Malaysia|1245.36.60008 Boehringer Ingelheim Investigational Site, Sabah, Malaysia|1245.36.60001 Boehringer Ingelheim Investigational Site, Selangor Darul Ehsan, Malaysia|1245.36.31015 Boehringer Ingelheim Investigational Site, Amersfoort, Netherlands|1245.36.31004 Boehringer Ingelheim Investigational Site, Den Haag, Netherlands|1245.36.31012 Boehringer Ingelheim Investigational Site, Geleen, Netherlands|1245.36.31017 Boehringer Ingelheim Investigational Site, Hardenberg, Netherlands|1245.36.31009 Boehringer Ingelheim Investigational Site, Maastricht, Netherlands|1245.36.31002 Boehringer Ingelheim Investigational Site, Utrecht, Netherlands|1245.36.31003 Boehringer Ingelheim Investigational Site, Zaandam, Netherlands|1245.36.63008 Boehringer Ingelheim Investigational Site, Cavite City, Philippines|1245.36.63006 Boehringer Ingelheim Investigational Site, Cebu, Philippines|1245.36.63005 Boehringer Ingelheim Investigational Site, Manila, Philippines|1245.36.63007 Boehringer Ingelheim Investigational Site, Manila, Philippines|1245.36.63009 Boehringer Ingelheim Investigational Site, Marikina, Philippines|1245.36.63010 Boehringer Ingelheim Investigational Site, Tacloban, Philippines|1245.36.48006 Boehringer Ingelheim Investigational Site, Gdansk, Poland|1245.36.48003 Boehringer Ingelheim Investigational Site, Lodz, Poland|1245.36.48004 Boehringer Ingelheim Investigational Site, Lodz, Poland|1245.36.48001 Boehringer Ingelheim Investigational Site, Lublin, Poland|1245.36.48002 Boehringer Ingelheim Investigational Site, Poznan, Poland|1245.36.48007 Boehringer Ingelheim Investigational Site, Ruda Slaska, Poland|1245.36.48005 Boehringer Ingelheim Investigational Site, Torun, Poland|1245.36.35003 Boehringer Ingelheim Investigational Site, Faro, Portugal|1245.36.35002 Boehringer Ingelheim Investigational Site, Lisboa, Portugal|1245.36.35004 Boehringer Ingelheim Investigational Site, Lisboa, Portugal|1245.36.35001 Boehringer Ingelheim Investigational Site, Vila Nova de Gaia, Portugal|1245.36.70008 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1245.36.70009 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1245.36.70011 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1245.36.70004 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1245.36.70006 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1245.36.70002 Boehringer Ingelheim Investigational Site, Vsevolozhsk, Russian Federation|1245.36.74011 Boehringer Ingelheim Investigational Site, Moldava nad Bodvou, Slovakia|1245.36.74013 Boehringer Ingelheim Investigational Site, Nitra, Slovakia|1245.36.74008 Boehringer Ingelheim Investigational Site, Nove Mesto Nad Vahom, Slovakia|1245.36.74012 Boehringer Ingelheim Investigational Site, Presov, Slovakia|1245.36.74007 Boehringer Ingelheim Investigational Site, Trencin, Slovakia|1245.36.74009 Boehringer Ingelheim Investigational Site, Zilina, Slovakia|1245.36.76021 Boehringer Ingelheim Investigational Site, Plumstead, South Africa|1245.36.76020 Boehringer Ingelheim Investigational Site, Somerset West, South Africa|1245.36.76022 Boehringer Ingelheim Investigational Site, Somerset West, South Africa|1245.36.34015 Boehringer Ingelheim Investigational Site, Barcelona, Spain|1245.36.34009 Boehringer Ingelheim Investigational Site, Granada, Spain|1245.36.34014 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat, Spain|1245.36.34012 Boehringer Ingelheim Investigational Site, Madrid, Spain|1245.36.34013 Boehringer Ingelheim Investigational Site, Madrid, Spain|1245.36.34020 Boehringer Ingelheim Investigational Site, Manresa, Spain|1245.36.34021 Boehringer Ingelheim Investigational Site, San Sebastian de los Reyes, Spain|1245.36.34016 Boehringer Ingelheim Investigational Site, Santiago de Compostela, Spain|1245.36.34017 Boehringer Ingelheim Investigational Site, Valencia, Spain|1245.36.34019 Boehringer Ingelheim Investigational Site, Valencia, Spain|1245.36.44018 Boehringer Ingelheim Investigational Site, Bath, United Kingdom|1245.36.44010 Boehringer Ingelheim Investigational Site, Birmingham, United Kingdom|1245.36.44013 Boehringer Ingelheim Investigational Site, Blackpool, United Kingdom|1245.36.44016 Boehringer Ingelheim Investigational Site, Blackpool, United Kingdom|1245.36.44012 Boehringer Ingelheim Investigational Site, Chesterfield, United Kingdom|1245.36.44026 Boehringer Ingelheim Investigational Site, Chester, United Kingdom|1245.36.44025 Boehringer Ingelheim Investigational Site, Doncaster, United Kingdom|1245.36.44036 Boehringer Ingelheim Investigational Site, Epsom, United Kingdom|1245.36.44001 Boehringer Ingelheim Investigational Site, Frome, United Kingdom|1245.36.44007 Boehringer Ingelheim Investigational Site, Midsomer Norton, United Kingdom|1245.36.44023 Boehringer Ingelheim Investigational Site, Nantwich, United Kingdom|1245.36.44024 Boehringer Ingelheim Investigational Site, Welwyn Garden City, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01164501

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress