Linagliptin approved by FDA for treatment of Type 2 diabetes
MedWire News: The US Food and Drug Administration (FDA) has approved the dipeptidyl peptidase (DPP)-4 inhibitor linagliptin for treatment of Type 2 diabetes.
Linagliptin is the most recent of three drugs in this class to be approved by the FDA; sitagliptin was the first to be approved in 2006 followed by saxagliptin in 2009.
The approval follows publication of several studies demonstrating linagliptin's efficacy and tolerability, as previously reported by MedWire News.
Linagliptin can be prescribed as a monotherapy or in combination with other commonly used oral antidiabetes drugs such as metformin, sulfonylureas, or pioglitazone.
In the trials leading up to its approval linagliptin was shown to reduce glycated hemoglobin (HbA1c) by up to 0.7% in patients with Type 2 diabetes when used as a monotherapy in comparison to placebo.
When used in combination with metformin, a sulfonylurea, metformin plus a sulfonylurea, or pioglitazone, linagliptin produced significant reductions in HbA1c of 0.6%, 0.5%, 0.6%, and 0.5%, respectively, when compared with placebo.
As with other DPP-4 inhibitors, linagliptin does not increase body weight compared with placebo. There is some evidence to suggest that it can decrease body weight to a small but significant degree (around 1-2 kg) compared with placebo, whereas more traditional antidiabetes drugs such as the sulfonylureas are known to increase body weight.
"This approval provides another treatment option for the millions of Americans with Type 2 diabetes," said Mary Parks, (Division of Metabolism and Endocrinology Products, FDA Center for Drug Evaluation and Research, Silverspring, Maryland, USA).
"It is effective when used alone or when added to existing treatment regimens," she added.
MedWire (www.medwire-news.md) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2011
By Helen Albert