TY - DATA T1 - Design of a 24-week trial of empagliflozin once daily in hypertensive black/African American patients with type 2 diabetes mellitus PY - 2017/12/11 AU - Keith C. Ferdinand AU - Leo Seman AU - Afshin Salsali UR - https://tandf.figshare.com/articles/media/Design_of_a_24-week_trial_of_empagliflozin_once_daily_in_hypertensive_Black_African_American_patients_with_type_2_diabetes_mellitus/5602714 DO - 10.6084/m9.figshare.5602714.v3 L4 - https://ndownloader.figshare.com/files/9959902 KW - African Americans KW - black KW - diabetes mellitus KW - type 2 KW - empagliflozin KW - humans KW - hypertension N2 - Objective: 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] A1c) 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. Methods: 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 HbA1c 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. Results: The study will report final data in 2018. Conclusions: 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.) ER -