Linagliptin as add-on hypoglycemic agent to metformin + sulfonylurea is effective and well-tolerated
November - 24 - 2011
The class of oral antidiabetic drugs dipeptidyl peptidase 4 (DPP IV) inhibitors offers new therapeutic options for type 2 diabetes (T2DM). The efficacy and tolerability of the novel DPP IV inhibitor linagliptin was investigated in a randomized, placebo-controlled, double-blind, parallel-group study. The patient population consisted of patients (n = 1,058) whose hyperglycemia could not be controlled by standard of care (metformin + sulfonylurea) and were recruited from 100 centers in 11 countries. After 24 weeks of treatment, mean HbA1c change from baseline in the linagliptin group corrected for placebo was –0.62%. The proportion of patients achieving the glycemic target of HbA1c < 7% was higher in the linagliptin (29.2%) than in the placebo group (8.1%). The linagliptin group also showed improvements in fasting plasma glucose and beta-cell function (HOMA-B). Hypoglycemia incidence was higher in the linagliptin (16.7%) than in the placebo group (10.3%) but more severe hypoglycemia cases were reported in the placebo (4.8%) than in the linagliptin group. Both linagliptin and placebo were well-tolerated and did not induce weight increase. The results demonstrated the superiority of linagliptin efficacy over placebo in glycemic control this patient population. Linagliptin showed benefits of beta-cell function improvement, a good safety profile, and being weight-neutral (Owens, D.R. et al. Diabet Med 2011, 28(11): 1352).