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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
166
starting dose 10mg; forced titration after 4 weeks 25mg dose
starting dose 10mg; forced titration after 4 weeks 25mg dose
starting dose 10mg; forced titration after 4 weeks 25mg dose
University of Alabama at Birmingham
Birmingham, Alabama, United States
Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC
Birmingham, Alabama, United States
Longwood Research
Huntsville, Alabama, United States
Internal Medicine Center, LLC
Mobile, Alabama, United States
Mobile Medical and Diagnostic Center
Mobile, Alabama, United States
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.
Time frame: baseline and 24 weeks
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and 24 weeks
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University of South Alabama
Mobile, Alabama, United States
Cardiology and Medicine Clinic
Little Rock, Arkansas, United States
Larry Watkins, M .D.
Little Rock, Arkansas, United States
eStudySite
Chula Vista, California, United States
Torrance Clinical Research Institute Inc.
Lomita, California, United States
...and 82 more locations