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

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] A_1c) 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 HbA_1c 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.)

Keywords:

• African Americans
• black
• diabetes mellitus
• type 2
• empagliflozin
• humans
• hypertension

Transparency

Declaration of funding

This study was funded by Boehringer Ingelheim.

Author contributions: The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE) and were fully responsible for all content and editorial decisions, and were involved at all stages of manuscript development. The authors received no direct compensation related to the development of the manuscript.

Declaration of financial/other relationships

K.C.F. has disclosed that he has received grant and/or research support from Boehringer Ingelheim, and has served as a consultant for Amgen, Boehringer Ingelheim, Novartis, Quantum Genomics, and Sanofi. L.S. and A.S. have disclosed that they are employees of Boehringer Ingelheim.

A reviewer on this manuscript declared themselves as a Principal Investigator on the DECLARE study with dapagliflozin. CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work.

Acknowledgements

Writing support was provided by Jennifer Garrett MB BS and Debra Brocksmith MB ChB, PhD of Envision Scientific Solutions, which was contracted and compensated by Boehringer Ingelheim Pharmaceuticals, Inc. for these services.