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.

• Authors: James Thrasher, David S Kountz, Susanne Crowe, Hans-Juergen Woerle, Maximilian von Eynatten
• Journal: Postgraduate medicine (Postgrad Med) Vol. 127 Issue 5 Pg. 419-28 (Jun 2015) ISSN: 1941-9260 [Electronic] England
• PMID: 25840727 (Publication Type: Journal Article, Meta-Analysis)

Chemical References

• Dipeptidyl-Peptidase IV Inhibitors
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Purines
• Quinazolines
• Linagliptin

Topics

• Argentina
• Black People
• Brazil
• Clinical Trials, Phase III as Topic
• Diabetes Mellitus, Type 2 (blood, drug therapy, ethnology)
• 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
• United States