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

“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

About Diabetes

An estimated 371 million people worldwide have Type 1 or Type 2 Diabetes;⁵ approximately one quarter of whom are aged ≥ 65 years.² Type 2 Diabetes is the most common type, accounting for an estimated 90-95 percent of all diabetes cases.⁶ Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.⁷

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
3. Tradjenta® (linagliptin) tablets. Highlights of Prescribing Information. Initial US Approval: 2011
4. EMA. Trajenta® (linagliptin) tablets. EMA Summary of Product Characteristics. 2011
5. International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: The Global Burden (2012 Update – 5th Edition).
6. Health Organization. Fact Sheet No. 312 What is Diabetes? 2009 [cited 2013 January 2013]; Available from: http://www.who.int/mediacentre/factsheets/fs312/en/index.html#
7. International Diabetes Federation. What is Diabetes? IDF Diabetes Atlas. 2011; (5th Edition)