Design of a 24-week trial of empagliflozin once daily in hypertensive black/African American patients with type 2 diabetes mellitus. (1st February 2018)

• Record Type: Journal Article
• Authors: Ferdinand, Keith C.; Seman, Leo; Salsali, Afshin
• Is Part Of: Current medical research and opinion. Volume 34:Number 2(2018)
• Page Start: 361
• Page End: 367
• Publication Date: 2018-02-01
• Subjects: African Americans -- black -- diabetes mellitus -- type 2 -- empagliflozin -- humans -- hypertension; Clinical medicine -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1080/03007995.2017.1405800
• Languages: English
• ISSNs: 0300-7995

Abstract

Abstract: 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.)