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

• Published in: Postgraduate medicine Vol. 127; no. 5; pp. 419 - 428
• Main Authors: Thrasher, James, Kountz, David S., Crowe, Susanne, Woerle, Hans-Juergen, von Eynatten, Maximilian
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 03-09-2015
• Subjects: African American; Argentina; black; Black or African American; Black People; Brazil; Clinical Trials, Phase III as Topic; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - ethnology; dipeptidyl peptidase-4; Dipeptidyl-Peptidase IV Inhibitors - therapeutic use; Fasting - blood; Female; Glycated Hemoglobin - metabolism; Humans; Hypoglycemic Agents - therapeutic use; Linagliptin; Male; Mexico; Purines - therapeutic use; Quinazolines - therapeutic use; Randomized Controlled Trials as Topic; Retrospective Studies; Treatment Outcome; Type 2 diabetes; United States; Brazil; Mexico; Argentina; United States; Type 2 diabetes; black; linagliptin; dipeptidyl peptidase-4; African American
• ISSN: 0032-5481; 1941-9260; 1941-9260
• DOI: 10.1080/00325481.2015.1027132

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.