Linagliptin, a dipeptidyl peptidase (DPP)-4 inhibitor, is a once-daily oral treatment in type 2 diabetes.
Boehringer Ingelheim said that the results of the trial were presented at the 70th Scientific Sessions of the American Diabetes Association (ADA).
Boehringer Ingelheim’s pivotal Phase III studies showed Linagliptin to have a very favourable safety profile.
Reportedly, in diabetes patients with mild and moderate renal impairment, Linagliptin blood plasma levels were comparable to those seen in diabetes patients with normal renal function, suggesting that Linagliptin, which has a primarily non-renal route of excretion, may have pharmacological features not yet seen in this new class of drugs.
The trial data suggested that Linagliptin would not need dose adjustment in patients with type 2 diabetes regardless of the stage of renal impairment.
In four multi-centre, 24 weeks, randomised, double-blind, controlled trials, reductions in blood glucose were observed with Linagliptin monotherapy versus placebo and when used in combination with other commonly used oral anti-diabetes drugs.
Additionally, Linagliptin monotherapy showed superiority in glucose lowering versus placebo and versus voglibose, the most commonly used alpha glucosidase inhibitor in Japan.
Julio Rosenstock, director of Dallas Diabetes and Endocrine Center at Medical City, said: “For Linagliptin, we see from studies that only approximately five percent of the orally administered drug is excreted via the kidneys.
“Data to date appear to indicate that Linagliptin would not require dose adjustment, which could translate into a benefit for physicians when choosing a treatment, not only for the type 2 diabetes patient population with diagnosed renal impairment, but also for those patients at risk of developing renal complications.”