Data shows that elderly people with type 2 diabetes (T2D) treated for 24 weeks with the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin (Tradjenta), marketed by Boehringer Ingelheim Pharmaceuticals, Inc. 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. This data was published in the Lancet.
Linagliptin, which is marketed as Tradjenta (linagliptin) tablets in the US, is a once-daily 5-mg tablet used along with diet and exercise to improve glycemic control in adults with T2D. Tradjenta should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). Tradjenta has not been studied in patients with a history of pancreatitis and it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using Tradjenta.
"Elderly individuals represent approximately 15 per cent of people with type 2 diabetes worldwide," said Professor Anthony H Barnett, MD, FRCP, Heart of England NHS Foundation Trust and University of Birmingham, United Kingdom. "This study may help inform treatment decisions for improving glycemic control in the elderly."
The publication reports on a 24-week, double-blind, parallel-group, multinational, phase III study in 241 elderly people (=70 years; mean age, 74.9 years) with T2D randomized to receive linagliptin 5 mg (n=162) or placebo (n=79), in addition to existing glucose-lowering drugs (i.e. metformin and/or sulfonylurea and/or basal insulin). The primary endpoint was change in HbA1c from baseline (7.8 per cent for linagliptin versus 7.7 per cent for placebo) to week 24. Key results from the study showed that the mean change from baseline in HbA1c with linagliptin was -0.64 per cent (p < 0.0001) after 24 weeks, which showed superiority versus placebo, adjusted for a mean 0.04 per cent HbA1C increase for placebo. In addition, analysis of a secondary endpoint showed that the placebo-adjusted mean reduction in fasting plasma glucose from baseline with linagliptin was -20.7 mg/dL (-1.15 mmol/L; p < 0.0001).
The percentage of people with any adverse event was the same in both treatment groups (75.9 per cent). Common adverse events included hypoglycemia (low blood glucose; 22.8 per cent and 16.5 per cent for linagliptin and placebo, respectively), nasopharyngitis (common cold; 10.5 per cent in the linagliptin arm and 8.9 per cent on placebo), diarrhoea (5.6 per cent in the linagliptin arm and 2.5 per cent on placebo), hyperglycemia (high blood glucose; 5.6 per cent and 10.1 per cent for linagliptin and placebo, respectively), back pain (7 per cent for linagliptin), fall (4.3 per cent and 2.5 per cent for linagliptin and placebo, respectively) and urinary tract infection (4.3 per cent in the linagliptin arm and 6.3 per cent on placebo). One patient per group had a drug-related adverse event leading to discontinuation of the study. Investigator-defined hypoglycemia occurred in 24.1 per cent of the linagliptin group and 16.5 per cent of the placebo group.
"Elderly people with type 2 diabetes have different challenges managing their blood sugar levels," said Christophe Arbet-Engels, MD, PhD, vice president, metabolic clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "This study shows linagliptin may help to reduce blood sugar levels in elderly people with inadequately controlled diabetes, and adds to the growing body of evidence for the safety and efficacy profile for linagliptin in this population."
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 sulfonylurea and/or basal insulin were randomized 2:1 to once-daily oral treatment with linagliptin 5 mg or placebo for 24 weeks.
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centres on three compounds representing several of the largest diabetes treatment classes. This alliance leverages the companies' strengths as two of the world's leading pharmaceutical companies, combining Boehringer Ingelheim's solid track record of research-driven innovation and Lilly's innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.
Boehringer Ingelheim Pharmaceuticals, Inc., is the largest U.S. subsidiary of Boehringer Ingelheim Corporation, committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
Lilly, a leading innovation-driven corporation is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organisations.