Trajenta® (Linagliptin): New Data On Safety And Efficacy In Type 2 Diabetes Patients With Moderate To Severe Renal Impairment
Data presented at the American Diabetes Association (ADA) 73rd Scientific Sessions® provides insights for use of Trajenta® (linagliptin) in adults with Type 2 Diabetes (T2D) with moderate to severe renal impairment
Boehringer Ingelheim and Eli Lilly and Company have announced results from a new study that demonstrated linagliptin showed statistically significant reduction in blood glucose levels (HbA1C) in adult patients with Type 2 Diabetes (T2D) with moderate to severe renal impairment (RI), compared with those receiving placebo (12 weeks). Most patients had T2D for more than ten years (76%) and were on insulin (86%). After 12 weeks, patients on placebo switched to glimepiride up to 52 weeks. The study found that patients treated with linagliptin had lower rates of hypoglycaemia and less weight gain than those who received glimepiride.1
“These are important findings for physicians managing patients with Type 2 Diabetes and renal impairment, which we are seeing more and more in today’s practice,” said Professor Markuu Laakso, Professor of Medicine at the Department of Medicine, University of Kuopio, Finland. “Approximately half of patients living with Type 2 Diabetes are also at risk of declining renal function, and treatment options for these patients can be limited. Ensuring that optimum blood glucose levels are achieved paired with the prevention of hypoglycaemic events is becoming more of a challenge.”
These new findings were derived from a doubleblind trial including 235 T2D patients with moderate to severe RI (estimated glomerular filtration rate <60 mL/min/1.73m2). Patients received linagliptin, 5 mg qd (n=113) or placebo (n=122) for 12 weeks, then placebo patients were switched to glimepiride 14 mg qd and treatment continued to week 52.
The primary endpoint was the reduction in HbA1c levels from baseline at 12 weeks.
Key results from the study showed:
- Greater mean reduction in baseline HbA1c at 12 weeks for patients treated with linagliptin vs. placebo (0.53±0.06% vs. 0.08±0.07%; p<0.0001)
- In the 40 week extension, HbA1c was lower with linagliptin vs. glimepiride (difference is not statistically significant)
- Less frequent hypoglycaemic events experienced with linagliptin vs. glimepiride (57.9% vs. 69.3%)
- Weight neutrality for linagliptin versus weight gain for patients treated with placebo followed by glimepiride (mean increase after 52 wks 0.06 kg linagliptin vs. 1.74 kg placebo/glimepiride)
The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory authorities worldwide approved linagliptin for the treatment of adult patients with T2D as monotherapy or in combination with metformin, with metformin and a sulphonylurea, and as addon therapy to insulin. With linagliptin, no dose adjustment is required regardless of declining renal function or hepatic impairment.2,3
Linagliptin (5 mg, once daily) is marketed in Europe as Trajenta® (linagliptin) and in the U.S. as Tradjenta® (linagliptin), as a oncedaily tablet that is used along with diet and exercise to improve glycaemic control in adults with T2D. Linagliptin should not be used in patients with Type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).2,3
1Laakso M, et al, Linagliptin vs placebo followed by glimepiride in Type 2 Diabetes patients with moderate tosever renal impairment. Poster No: 1090-P. Presented at the American Diabetes Association (ADA) 73rd Scientific Sessions®. June 21-25, Chicago, IL.
2Tradjenta™ (linagliptin) tablets. Highlights of Prescribing Information. Initial US Approval: 2011.
3EMA. Trajenta® (linagliptin) tablets. EMA Summary of Product Characteristics. 2011.
4International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: The Global Burden (2012 Update – 5th Edition).
5Health Organization. Fact Sheet No. 312 What is Diabetes? 2009 [cited 2013 January 2013];
6International Diabetes Federation. What is Diabetes? IDF Diabetes Atlas. 2011; (5th Edition)