Friday, August 16, 2013

Phase III safety and efficacy data of Trajenta® (linagliptin) in elderly people with Type 2 Diabetes published in The Lancet

Linagliptin demonstrated clinically important HbA1c reduction, safety and tolerability profile in elderly people with Type 2 Diabetes with inadequate glycaemic control

INGELHEIM, Germany & INDIANAPOLIS, US - Thursday, August 15th 2013 [ME NewsWire]

(BUSINESS WIRE)-- For Non-US and Non-UK Media

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 (n=162) or placebo (n=79), in addition to existing glucose-lowering drugs (i.e. metformin and/or sulphonylurea and/or basal insulin). The primary endpoint was change in HbA1c from baseline to week 24. Key results from the study showed that the placebo-adjusted mean change from baseline in HbA1c with linagliptin was −0.64 percent (p<0.0001) after 24 weeks, which showed superiority versus placebo for the primary endpoint. In addition, the placebo-adjusted mean reduction in fasting plasma glucose from baseline with linagliptin was −1.15 mmol/L (p<0.0001).

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.”

About the study

The study was conducted at 33 centres in five countries (Australia, Canada, Denmark, The Netherlands and Sweden). A total of 241 people who were ≥70 years with T2D, had HbA1c of ≥7·0 percent and received metformin and/or sulphonylurea and/or basal insulin were randomised 2:1 to once-daily oral treatment with linagliptin 5mg or placebo for 24 weeks.

About Linagliptin

Linagliptin (5 mg, once daily) is marketed in Europe as Trajenta® (linagliptin) and in the U.S. as Tradjenta® (linagliptin), as a once-daily tablet that is used along with diet and exercise to improve glycaemic control in adults with T2D. Linagliptin should not be used in people with Type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). 3,4


Please click on the link below for ‘Notes to Editors’ and ‘References’:


Dr. Petra Kienle

Launch and Established Products CVM

Boehringer Ingelheim GmbH


Phone: +49 (6132) 77-143877

Tammy Hull

Communications Manager

Eli Lilly and Company


Phone: +1 (317) 651-9116


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