24 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus and Hypertension
- Conditions
- Diabetes Mellitus, Type 2Hypertension
- Interventions
- Registration Number
- NCT02182830
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This trial is designed to investigate the efficacy and safety of empagliflozin compared with placebo in hypertensive black/African Americans with type 2 Diabetes Mellitus. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and BP lowering effects of empagliflozin in hypertensive African American patients with type 2 Diabetes Mellitus could provide clinically highly relevant, new information for the use of empagliflozin.
Essential hypertension is four times more common in African Americans than in Caucasians.
One of the risk factors for hypertension is sodium sensitivity and approximately one third of the essential hypertensive population is responsive to sodium intake. There is a higher association of hypertension with sodium sensitivity in African American patients with type 2 Diabetes Mellitus.
The treatment duration of this trial (24 weeks) will enable assessment of the clinically relevant endpoint of a decrease in HbA1c, a well accepted measurement of chronic glycaemic control and the key secondary endpoints of decreases in systolic BP (SBP) and diastolic BP (DBP) at 12 and 24 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Empagliflozin Empagliflozin low dose starting dose 10mg; forced titration after 4 weeks 25mg dose Placebo placebo starting dose 10mg; forced titration after 4 weeks 25mg dose Empagliflozin Empagliflozin high dose starting dose 10mg; forced titration after 4 weeks 25mg dose
- Primary Outcome Measures
Name Time Method Change From Baseline in Glycated Haemoglobin (HbA1c) (%) at 24 Weeks baseline and 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.
- Secondary Outcome Measures
Name Time Method Changes From Baseline in Trough Mean Ambulatory SBP at Week 12 baseline and 12 weeks 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 endpointChange From Baseline in Body Weight at Week 24 baseline and 24 weeks 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 endpointChange From Baseline in Trough Seated SBP at Week 12 baseline and 12 weeks 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 endpointChange From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (SBP) at Week 12 baseline and 12 weeks 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 endpointChange From Baseline in Mean 24-hour Ambulatory SBP (mmHg) at Week 24 baseline and 24 weeks 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.Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (DBP) at Week 12 baseline and 12 weeks 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.Change From Baseline in Mean 24-hour Ambulatory DBP (mmHg) at Week 24 baseline and 24 weeks 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.Change From Baseline in Trough Seated SBP (mmHg) at Week 24 baseline and 24 weeks 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.Change From Baseline in Trough Seated DBP (mmHg) at Week 12 baseline and 12 weeks 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.Change From Baseline in Trough Seated DBP (mmHg) at Week 24 baseline and 24 weeks 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.
Trial Locations
- Locations (89)
Atlanta Clinical Research Centers
🇺🇸Atlanta, Georgia, United States
Albert F. Johary MD, PC
🇺🇸Dunwoody, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
University of South Alabama
🇺🇸Mobile, Alabama, United States
Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC
🇺🇸Marietta, Georgia, United States
Longwood Research
🇺🇸Huntsville, Alabama, United States
MD Clinical Trials
🇺🇸Los Angeles, California, United States
Long Beach Center for Clinical Research
🇺🇸Long Beach, California, United States
Office of Dr. Alexander Ford, M.D.
🇺🇸Los Angeles, California, United States
Orange County Research Center
🇺🇸Tustin, California, United States
UF Health Jacksonville
🇺🇸Jacksonville, Florida, United States
Care Partners Clinical Research LLC
🇺🇸Jacksonville, Florida, United States
Morehouse School of Medicine
🇺🇸Atlanta, Georgia, United States
Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States
John H. Stroger Jr. Hospital of Cook Country
🇺🇸Chicago, Illinois, United States
Mercy Research
🇺🇸Washington, Missouri, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
Metrolina Internal Medicine, PA
🇺🇸Charlotte, North Carolina, United States
High Point Clinical Trials Center
🇺🇸High Point, North Carolina, United States
Laurelton Heart Specialist, PC
🇺🇸Rosedale, New York, United States
Temple University School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Hometown Urgent Care
🇺🇸Columbus, Ohio, United States
TLM Medical Services, LLC
🇺🇸Columbia, South Carolina, United States
The Green Clinic PC
🇺🇸Memphis, Tennessee, United States
Kelsey-Seybold Clinic
🇺🇸Houston, Texas, United States
Hillcrest Family Health Center
🇺🇸Waco, Texas, United States
Cullen Family Practice, PLLC
🇺🇸Houston, Texas, United States
Texas Center for Drug Development, Inc.
🇺🇸Houston, Texas, United States
Clinical Research Partners, LLC
🇺🇸Richmond, Virginia, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Lynn Institute of Denver
🇺🇸Denver, Colorado, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Quality Clinical Research Inc
🇺🇸Omaha, Nebraska, United States
Family Medical Clinic
🇺🇸Milwaukee, Wisconsin, United States
eStudySite
🇺🇸Chula Vista, California, United States
Pines Clinical Research Inc.
🇺🇸Hollywood, Florida, United States
Sunshine Research Center
🇺🇸Opa-locka, Florida, United States
Atlanta Center
🇺🇸Atlanta, Georgia, United States
Alternative Solutions Medical Research and Prevention Center
🇺🇸Saint Petersburg, Florida, United States
Accord Clinical Research, LLC
🇺🇸Port Orange, Florida, United States
Cedar Crosse Research Center
🇺🇸Chicago, Illinois, United States
Centex Studies, Inc.
🇺🇸Houston, Texas, United States
PhysiqueMed Clinical Trials
🇺🇸Greensboro, North Carolina, United States
Lovelace Scientific Resources, Inc.
🇺🇸Albuquerque, New Mexico, United States
Peters Medical Research
🇺🇸High Point, North Carolina, United States
Diagnostic Clinic of Houston
🇺🇸Houston, Texas, United States
Dayton Clinical Research
🇺🇸Dayton, Ohio, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
York Clinical Research, LLC
🇺🇸Norfolk, Virginia, United States
Dominion Medical Associates, Inc.
🇺🇸Richmond, Virginia, United States
Erie County Medical Center
🇺🇸Buffalo, New York, United States
Medex Healthcare Research, Inc.
🇺🇸New York, New York, United States
Offic of Dr. Eric Cheng
🇺🇸Brooklyn, New York, United States
Internal Medicine Center, LLC
🇺🇸Mobile, Alabama, United States
Integrated Research Group, Inc.
🇺🇸Riverside, California, United States
Healthwise Medical Associates
🇺🇸Brooklyn, New York, United States
Larry Watkins, M .D.
🇺🇸Little Rock, Arkansas, United States
Modern Medical
🇺🇸Brooklyn, New York, United States
Investigators Research Group, LLC
🇺🇸Brownsburg, Indiana, United States
Torrance Clinical Research Institute Inc.
🇺🇸Lomita, California, United States
Eagle's Landing Diabetes and Endocrinology
🇺🇸Stockbridge, Georgia, United States
New Orleans Center for Clinical Research
🇺🇸New Orleans, Louisiana, United States
Sestron Clinical Research
🇺🇸Marietta, Georgia, United States
American Institute of Research Studies
🇺🇸Baltimore, Maryland, United States
WR-Mount Vernon Clinical Research, LLC
🇺🇸Sandy Springs, Georgia, United States
Phillips Medical Services, PLLC
🇺🇸Jackson, Mississippi, United States
Today Clinical Research, Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
Coastal Carolina Health Care, P.A.
🇺🇸New Bern, North Carolina, United States
Berkley Family Practice
🇺🇸Moncks Corner, South Carolina, United States
Amistad Clinical Research Center
🇺🇸Columbia, South Carolina, United States
Millennium Clinical Trials LLC
🇺🇸Arlington, Virginia, United States
Diabetes Associates Medical Group
🇺🇸Orange, California, United States
Mobile Medical and Diagnostic Center
🇺🇸Mobile, Alabama, United States
Scott Research, Inc.
🇺🇸Laurelton, New York, United States
Triad Clinical Trials
🇺🇸Greensboro, North Carolina, United States
Clinical Trials Research
🇺🇸Sacramento, California, United States
Central Florida Internist
🇺🇸Orlando, Florida, United States
Accent Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Cardiology and Medicine Clinic
🇺🇸Little Rock, Arkansas, United States
Medical Research South
🇺🇸Charleston, South Carolina, United States
Greenville Pharmaceutical Rsch
🇺🇸Greenville, South Carolina, United States
Mountain View Clinical Research
🇺🇸Greer, South Carolina, United States
Community Research Partners, Inc
🇺🇸Varnville, South Carolina, United States
Southwind Medical Specialists
🇺🇸Memphis, Tennessee, United States
University of Tennessee
🇺🇸Memphis, Tennessee, United States
Gulf Regional Research and Education Services, LLC
🇺🇸Metairie, Louisiana, United States
Memphis Veterans Affairs Medical Center
🇺🇸Memphis, Tennessee, United States
International Clinical Research - US, LLC
🇺🇸Sanford, Florida, United States
Carolina Cardiology Clinical Research Institute, LLC
🇺🇸Rock Hill, South Carolina, United States