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Published on 17 August 2013

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Phase III safety and efficacy data of Trajenta®

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)

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 Diabetes;(2) 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% (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%). Common adverse events included hypoglycaemia (22.8% and 16.5% for linagliptin and placebo, respectively), nasopharyngitis (10.5% in the linagliptin arm and 8.9% on placebo), diarrhoea (5.6% in the linagliptin arm and 2.5% on placebo), and hyperglycaemia (5.6% and 10.1% 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.”
References
  1. Barnett A et al. Treatment of elderly patients (≥70 years) with Type 2 Diabetes inadequately controlled on common anti-diabetes therapies: A randomised, double-blind, placebo-controlled trial with the dipeptidyl peptidase-4 inhibitor linagliptin. Lancet. 2013 Aug 13. Doi: pii: S0140-6736(13)61693-1 [Epub ahead of print]
  2. Merck Manuals; Hormonal and Metabolic Disorders; Diabetes Mellitus; Accessed online: 29 July 2013


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