Linagliptin Demonstrated Significant HbA1c Reduction in Elderly People With Type 2 Diabetes With Inadequate Glycemic Control

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 (TRADJENTA®), marketed by Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (Lilly; NYSE: LLY), 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.1 Linagliptin, which is marketed as TRADJENTA® (linagliptin) tablets in the U.S., 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 percent of people with type 2 diabetes worldwide,2" 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 percent for linagliptin versus 7.7 percent for placebo) to week 24. Key results from the study showed that the mean change from baseline in HbA1c with linagliptin was -0.64 percent (p<0.0001) after 24 weeks, which showed superiority versus placebo, adjusted for a mean 0.04 percent 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 percent). Common adverse events included hypoglycemia (low blood glucose; 22.8 percent and 16.5 percent for linagliptin and placebo, respectively), nasopharyngitis (common cold; 10.5 percent in the linagliptin arm and 8.9 percent on placebo), diarrhea (5.6 percent in the linagliptin arm and 2.5 percent on placebo), hyperglycemia (high blood glucose; 5.6 percent and 10.1 percent for linagliptin and placebo, respectively), back pain (7 percent for linagliptin), fall (4.3 percent and 2.5 percent for linagliptin and placebo, respectively) and urinary tract infection (4.3 percent in the linagliptin arm and 6.3 percent 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 percent of the linagliptin group and 16.5 percent 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." About the study The study was conducted at 33 centers 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.