Efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin in black/African American patients with type 2 diabetes: Pooled analysis from eight Phase III trials

Abstract

Background. The prevalence of type 2 diabetes in black/African Americans from North and South America is high; yet data evaluating antidiabetic agents in this population is scarce. To address this gap, we pooled data from the clinical development program for linagliptin. Methods. A retrospective pooled analysis of eight completed randomized, placebo-controlled Phase III trials of linagliptin identified 336 patients with type 2 diabetes who self-identified their ethnicity as black or African American. Participants received linagliptin (n = 173, 5 mg/day) or placebo (n = 163) as monotherapy, or as add-on to other antidiabetic agents, including insulin. The primary end point was the change in glycated hemoglobin (HbA1c) from baseline to week 18 or 24. Results. The placebo-adjusted mean change (95% confidence interval [CI]) in HbA1c from baseline was –0.69% (–0.92 to –0.46; p < 0.0001) at week 18 (eight trials), and –0.64% (–0.90 to –0.39; p < 0.0001) at week 24 (six trials). The placebo-adjusted mean change (95% CI) in fasting plasma glucose from baseline was −11.7 mg/dL (−23.1 to –0.3; p = 0.0446) at week 18 and –14.7 mg/dL (–25.7 to –3.8; p = 0.0087) at week 24. Incidence of investigator-defined hypoglycemia was similar between the two groups (linagliptin, 12.1%; placebo, 11.7%). Overall, the safety profile of linagliptin in this patient group was comparable to that of placebo, with comparable incidence of adverse events; linagliptin was weight-neutral in this patient population. Conclusion. Linagliptin provided clinically significant improvements in glycemic control without increased risk of hypoglycemia and without weight gain, representing a useful type 2 diabetes therapy option for the black/African American population.

Video abstract

Keywords :

• Type 2 diabetes
• linagliptin
• dipeptidyl peptidase-4
• black
• African American

Declaration of interest

The authors received no direct compensation related to the development of the manuscript. Writing, editorial support, and formatting assistance was provided by Dhinakaran Sambandan, PhD, of Envision Scientific Solutions, which was contracted and funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations. J Thrasher has received research grant support from Amgen, Aventis, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Janssen, Gilead Sciences, GlaxoSmithKline, Medtronic, Merck & Co., Novartis, Novo Nordisk, Pfizer, Sanofi, Speedel Pharma Ltd, and Yamanouchi Pharma America; he has served on the speaker bureau for Amylin, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Janssen, Lilly, Medtronic, Novo Nordisk, Pfizer, Sanofi, Takeda, and Vivus, and is on advisory boards for Medtronic, Pfizer Pharmaceuticals, and Sanofi-Aventis; and has received editorial/publication support from Boehringer Ingelheim, Eli Lilly, and Sanofi. S Crowe, M von Eynatten, and H-J Woerle are employees of Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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