Optimal Dose of Linagliptin Determined for Pediatric T2D
Linagliptin was well-tolerated and effective in reducing HbA1c and fasting plasma glucose.
Pediatric patients with type 2 diabetes (T2D) treated with 5 mg of linagliptin may have more favorable clinical profiles than those treated with 1 mg, according to a study published in Pediatric Diabetes. Linagliptin is a potent dipeptidyl peptidase-4 (DPP-4) inhibitor eliminated predominantly by nonrenal excretion and currently approved for adults with T2D in the United States.
Researchers enrolled 39 children diagnosed with T2D from 24 sites in 9 different countries in a randomized, double-blind, placebo-controlled, dose-finding trial to determine the appropriate treatment dose of linagliptin for pediatric patients with T2D.
A dose-dependent reduction in hemoglobin A1c was found in study participants treated with 1 mg and 5 mg of linagliptin of 0.48% (95% CI, -1.47 to 0.51; P =.3295) and 0.63% (95% CI, -1.50 to 0.23; P =.1447), respectively, when compared with treatment with placebo.
Trough levels of 1 mg (3.80 nmol/L) and 5 mg (7.42 nmol/L) doses of linagliptin were slightly higher in the pediatric participants in this study compared with trough levels attained in adults, but levels were still within normal range.
Median DPP-4 inhibition was 38% and 79% for 1-mg and 5-mg treatment groups, respectively. Interestingly, no drug-related adverse events were found in either the 1-mg or 5-mg treatment groups during the course of treatment.
Researchers concluded that linagliptin was well tolerated and effective in reducing hemoglobin A1c and fasting plasma glucose levels in pediatric patients with T2D, findings which are comparable to those of adult studies of this drug and favor the use of the 5-mg dose of linagliptin over the 1-mg dose. Data from this study support a phase 3 trial study of linagliptin 5 mg in pediatric patients with T2D.
Tamborlane WV, Laffel LM, Weill J, et al. Randomized, double-blind, placebo-controlled dose-finding study of the dipeptidyl peptidase-4 inhibitor linagliptin in pediatric patients with type 2 diabetes [published online November 24, 2017]. Pediatr Diabetes. doi: 10.1111/pedi.12616