Study: Type 2 diabetic patients treated with DPP-4 linagliptin experience reductions in blood glucose levels

The LancetAug 17 2013

“This study provides much-needed data on glucose-lowering treatment of elderly people with Type 2 Diabetes, inadequately controlled with common anti-hyperglycaemic agents”

Data published in The Lancet showed that elderly people with Type 2 Diabetes (T2D) treated for 24 weeks with the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin, marketed by Boehringer Ingelheim and Eli Lilly and Company, experienced significant reductions in blood glucose levels (HbA1c) compared with those receiving placebo. In addition, the overall safety and tolerability profile of linagliptin was similar to placebo, with no significant difference in hypoglycaemia.¹

"Elderly individuals comprise approximately 15% of people with Type 2 Diabetes²; however, few glucose-lowering agents have been investigated in this group. This evidence gap hinders clinical decision-making as the risks and benefits of treatment may be unclear," said Professor Anthony H. Barnett, MD, FRCP, Heart of England NHS Foundation Trust and University of Birmingham, United Kingdom. "This study may inform treatment decisions for improving individualised glycaemic goals in the elderly."

The publication reports on a 24-week, double-blind, parallel-group, multinational, Phase III study in 241 elderly people (≥70 years) with T2D randomised to receive linagliptin 5mg>

The percentage of people reporting adverse events was the same in both treatment groups (75.9 percent). Common adverse events included hypoglycaemia (22.8 percent and 16.5 percent for linagliptin and placebo, respectively), nasopharyngitis (10.5 percent in the linagliptin arm and 8.9 percent on placebo), diarrhoea (5.6 percent in the linagliptin arm and 2.5 percent on placebo), and hyperglycaemia (5.6 percent and 10.1 percent for linagliptin and placebo, respectively). Drug-related adverse events leading to discontinuation of the study drug was the same in both treatment groups (one patient per group).

"This study provides much-needed data on glucose-lowering treatment of elderly people with Type 2 Diabetes, inadequately controlled with common anti-hyperglycaemic agents," said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "The results support linagliptin's efficacy and safety profile in these patients, a prevalent population for which many other treatment options may have important limitations."