Strong date from Boehringer Ingelheim and Bristol-Myers/AstraZeneca on diabetes drugs presented at ADA

Continuing the string of positive news on diabetes drug developments at the ongoing 70th Scientific Sessions of the American Diabetes Association (ADA) being held in Orlando, Florida, were independent German drug major Boehringer Ingelheim with its linagliptin, and Bristol-Myers Squibb and partner AstraZeneca, which are developing Onglyza (saxagliptin).

Linagliptin Phase III data were presented for the first time this week at the ADA, showing that this investigational compound, a dipeptidyl peptidase (DPP)-4 inhibitor, achieved significant, sustained and clinically meaningful reductions in blood glucose as measured by haemoglobin A1c (HbA1c), fasting plasma glucose (FPG), and postprandial glucose (PPG) concentrations. Linagliptin is being investigated by Boehringer Ingelheim as a once-daily oral treatment in type 2 diabetes.

In the pivotal Phase III studies, linagliptin was shown to have a very favorable safety profile, with an overall rate of adverse events similar to placebo. In addition, linagliptin showed an excellent tolerability, was weight neutral, showed no increased risk of drug-drug interactions and, importantly, there was no increased risk of hypoglycemia attributed to linagliptin use in monotherapy, or combination therapy with metformin or pioglitazone. Notably, 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 distinct pharmacological features not yet seen in this novel class of drugs. The data suggest that linagliptin would not need dose adjustment in patients with type 2 diabetes regardless of the stage of renal impairment.