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Clinical Trial Details

Trial ID: L1813
Source ID: NCT02182830
Associated Drug: Empagliflozin Low Dose
Title: 24 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus and Hypertension
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02182830/results
Conditions: Diabetes Mellitus, Type 2|Hypertension
Interventions: DRUG: Empagliflozin low dose|DRUG: placebo|DRUG: Empagliflozin high dose
Outcome Measures: Primary: Change From Baseline in Glycated Haemoglobin (HbA1c) (%) at 24 Weeks, Change from baseline in HbA1c (%) at 24 weeks is presented. The term "baseline" refers to the last observation prior to randomisation of the patient. Means presented are the adjusted means. Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) model is used in the statistical analysis., baseline and 24 weeks | Secondary: Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (SBP) at Week 12, Change from baseline in mean 24-hour ambulatory Systolic blood pressure SBP at Week 12 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient. Means presented are the adjusted means. This is a key secondary endpoint, baseline and 12 weeks|Changes From Baseline in Trough Mean Ambulatory SBP at Week 12, Changes from baseline in trough mean ambulatory SBP at Week 12 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient. Means presented are the adjusted means. This is a key secondary endpoint, baseline and 12 weeks|Change From Baseline in Body Weight at Week 24, Changes from baseline in body weight at Week 24 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient. Means presented are the adjusted means. This is a key secondary endpoint, baseline and 24 weeks|Change From Baseline in Trough Seated SBP at Week 12, Change from baseline in trough seated SBP (mmHg) at Week 12 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient. Means presented are the adjusted means. This is a key secondary endpoint, baseline and 12 weeks|Change From Baseline in Mean 24-hour Ambulatory SBP (mmHg) at Week 24, Change from baseline in mean 24-hour ambulatory SBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient. Means presented are the adjusted means., baseline and 24 weeks|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (DBP) at Week 12, Change from baseline in mean 24-hour ambulatory DBP (mmHg) at Week 12. The term "baseline" refers to the last observation prior to randomisation of the patient. Means presented are the adjusted means., baseline and 12 weeks|Change From Baseline in Mean 24-hour Ambulatory DBP (mmHg) at Week 24, Change from baseline in mean 24-hour ambulatory DBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient. Means presented are the adjusted means., baseline and 24 weeks|Change From Baseline in Trough Seated SBP (mmHg) at Week 24, Change from baseline in trough seated SBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient. Means presented are the adjusted means., baseline and 24 weeks|Change From Baseline in Trough Seated DBP (mmHg) at Week 12, Change from baseline in trough seated DBP (mmHg) at Week 12 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient. Means presented are the adjusted means., baseline and 12 weeks|Change From Baseline in Trough Seated DBP (mmHg) at Week 24, Change from baseline in trough seated DBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient. Means presented are the adjusted means., baseline and 24 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 166
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2014-07-25
Completion Date: 2017-05-18
Results First Posted: 2018-07-31
Last Update Posted: 2018-07-31
Locations: University of Alabama at Birmingham, Birmingham, Alabama, 35205, United States|Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC, Birmingham, Alabama, 35211, United States|Longwood Research, Huntsville, Alabama, 35801, United States|Internal Medicine Center, LLC, Mobile, Alabama, 36608, United States|Mobile Medical and Diagnostic Center, Mobile, Alabama, 36617, United States|University of South Alabama, Mobile, Alabama, 36617, United States|Cardiology and Medicine Clinic, Little Rock, Arkansas, 72204, United States|Larry Watkins, M .D., Little Rock, Arkansas, 72205, United States|eStudySite, Chula Vista, California, 91911, United States|Torrance Clinical Research Institute Inc., Lomita, California, 90717, United States|Long Beach Center for Clinical Research, Long Beach, California, 90807, United States|MD Clinical Trials, Los Angeles, California, 90025, United States|Office of Dr. Alexander Ford, M.D., Los Angeles, California, 90035, United States|Diabetes Associates Medical Group, Orange, California, 92868, United States|Integrated Research Group, Inc., Riverside, California, 92506, United States|Clinical Trials Research, Sacramento, California, 95821, United States|Orange County Research Center, Tustin, California, 92780, United States|Lynn Institute of Denver, Denver, Colorado, 80246, United States|Pines Clinical Research Inc., Hollywood, Florida, 33024, United States|UF Health Jacksonville, Jacksonville, Florida, 32207, United States|Care Partners Clinical Research LLC, Jacksonville, Florida, 32277, United States|Sunshine Research Center, Opa-locka, Florida, 33054, United States|Central Florida Internist, Orlando, Florida, 32811, United States|Accord Clinical Research, LLC, Port Orange, Florida, 32129, United States|Meridien Research, Saint Petersburg, Florida, 33709, United States|Alternative Solutions Medical Research and Prevention Center, Saint Petersburg, Florida, 33711, United States|International Clinical Research - US, LLC, Sanford, Florida, 32771, United States|Meridien Research, Tampa, Florida, 33634, United States|Grady Memorial Hospital, Atlanta, Georgia, 30303, United States|Morehouse School of Medicine, Atlanta, Georgia, 30310, United States|Atlanta Center, Atlanta, Georgia, 30331, United States|Atlanta Clinical Research Centers, Atlanta, Georgia, 30342, United States|Albert F. Johary MD, PC, Dunwoody, Georgia, 30338, United States|Sestron Clinical Research, Marietta, Georgia, 30060, United States|Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC, Marietta, Georgia, 30067, United States|WR-Mount Vernon Clinical Research, LLC, Sandy Springs, Georgia, 30328, United States|Eagle's Landing Diabetes and Endocrinology, Stockbridge, Georgia, 30281, United States|Cedar Crosse Research Center, Chicago, Illinois, 60607, United States|John H. Stroger Jr. Hospital of Cook Country, Chicago, Illinois, 60612, United States|University of Chicago, Chicago, Illinois, 60637, United States|Investigators Research Group, LLC, Brownsburg, Indiana, 46112, United States|Centex Studies, Inc., Lake Charles, Louisiana, 70601, United States|Gulf Regional Research and Education Services, LLC, Metairie, Louisiana, 70002, United States|New Orleans Center for Clinical Research, New Orleans, Louisiana, 70119, United States|University of Maryland School of Medicine, Baltimore, Maryland, 21201, United States|American Institute of Research Studies, Baltimore, Maryland, 21218, United States|Phillips Medical Services, PLLC, Jackson, Mississippi, 39209, United States|Mercy Research, Washington, Missouri, 63090-4700, United States|Quality Clinical Research Inc, Omaha, Nebraska, 68114, United States|Accent Clinical Trials, Las Vegas, Nevada, 89106, United States|Lovelace Scientific Resources, Inc., Albuquerque, New Mexico, 87108, United States|Offic of Dr. Eric Cheng, Brooklyn, New York, 11203-1203, United States|Healthwise Medical Associates, Brooklyn, New York, 11206, United States|Modern Medical, Brooklyn, New York, 11207, United States|Erie County Medical Center, Buffalo, New York, 14215, United States|Scott Research, Inc., Laurelton, New York, 11413, United States|Medex Healthcare Research, Inc., New York, New York, 10036, United States|Laurelton Heart Specialist, PC, Rosedale, New York, 11422, United States|Metrolina Internal Medicine, PA, Charlotte, North Carolina, 28204, United States|PhysiqueMed Clinical Trials, Greensboro, North Carolina, 27405, United States|Triad Clinical Trials, Greensboro, North Carolina, 27410, United States|Peters Medical Research, High Point, North Carolina, 27262, United States|High Point Clinical Trials Center, High Point, North Carolina, 27265, United States|Coastal Carolina Health Care, P.A., New Bern, North Carolina, 28562, United States|Hometown Urgent Care, Columbus, Ohio, 43214, United States|Dayton Clinical Research, Dayton, Ohio, 45406, United States|Today Clinical Research, Oklahoma City, Oklahoma City, Oklahoma, 73129, United States|Suburban Research Associates, Media, Pennsylvania, 19063, United States|Temple University School of Medicine, Philadelphia, Pennsylvania, 19140, United States|Medical Research South, Charleston, South Carolina, 29407, United States|TLM Medical Services, LLC, Columbia, South Carolina, 29204, United States|Amistad Clinical Research Center, Columbia, South Carolina, 29223, United States|Greenville Pharmaceutical Rsch, Greenville, South Carolina, 29615, United States|Mountain View Clinical Research, Greer, South Carolina, 29651, United States|Berkley Family Practice, Moncks Corner, South Carolina, 29461, United States|Carolina Cardiology Clinical Research Institute, LLC, Rock Hill, South Carolina, 29732, United States|Community Research Partners, Inc, Varnville, South Carolina, 29944, United States|Memphis Veterans Affairs Medical Center, Memphis, Tennessee, 38104, United States|The Green Clinic PC, Memphis, Tennessee, 38119, United States|Southwind Medical Specialists, Memphis, Tennessee, 38125, United States|University of Tennessee, Memphis, Tennessee, 38163, United States|Diagnostic Clinic of Houston, Houston, Texas, 77004, United States|Cullen Family Practice, PLLC, Houston, Texas, 77051, United States|Centex Studies, Inc., Houston, Texas, 77058, United States|Texas Center for Drug Development, Inc., Houston, Texas, 77081, United States|Kelsey-Seybold Clinic, Houston, Texas, 77096, United States|Hillcrest Family Health Center, Waco, Texas, 76710, United States|Millennium Clinical Trials LLC, Arlington, Virginia, 22203, United States|York Clinical Research, LLC, Norfolk, Virginia, 23510, United States|Dominion Medical Associates, Inc., Richmond, Virginia, 23219, United States|Clinical Research Partners, LLC, Richmond, Virginia, 23235, United States|Family Medical Clinic, Milwaukee, Wisconsin, 53216, United States
URL: https://clinicaltrials.gov/show/NCT02182830

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress