Design of a 24-week trial of empagliflozin once daily in hypertensive black/African American patients with type 2 diabetes mellitus

<p><b>Objective:</b> Black/African American individuals have a higher prevalence of type 2 diabetes mellitus (T2DM), diabetes-related complications and hypertension, but they are often underrepresented in clinical trials. The sodium–glucose co-transporter 2 inhibitor, empagliflozin, was associated with significant improvements in glucose control (via hemoglobin [Hb] A<sub>1c</sub>) and reductions in blood pressure (BP; via office and ambulatory BP monitoring) in a primarily white population with T2DM and hypertension. The aim of this ongoing study is to assess the safety and efficacy of empagliflozin in terms of glucose- and BP-lowering in a self-identified black/African American population with T2DM and hypertension.</p> <p><b>Methods:</b> This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3b study carried out at 85 centers in the USA. It was designed to assess the safety and efficacy of empagliflozin (10 or 25 mg/day) versus placebo in black/African American patients with uncontrolled T2DM and hypertension. Patients receiving stable glucose-lowering therapy prestudy continued at the same dose during the trial; BP-lowering medication was also held stable. The primary endpoint was the change from baseline in HbA<sub>1c</sub> at Week 24. Key secondary endpoints were change from baseline in: mean 24-hour ambulatory systolic BP (SBP) at Week 12, mean trough ambulatory SBP at Week 12, body weight at Week 24 and trough seated SBP at Week 12.</p> <p><b>Results:</b> The study will report final data in 2018.</p> <p><b>Conclusions:</b> Results of this study will add to our understanding of the efficacy and safety of empagliflozin in self-identified black/African American patients with T2DM and hypertension. (ClinicalTrials.gov identifier: NCT02182830.)</p>