Additionally, a pharmacokinetic study was presented, which investigated linagliptin in a special patient population with different degrees of renal impairment.
Linagliptin belongs to the new class of DPP-4 inhibitors and is currently in late stage development as a once-daily, single-dose oral tablet.
Boehringer said that the new data add to the large body of clinical evidence demonstrating that linagliptin cannot only achieve significant and sustainable reductions in blood glucose, but that based on its pharmacokinetic profile, linagliptin may not require dose adjustment even in patients with type 2 diabetes with any degree of renal impairment.
Boehringer Ingelheim is filing linagliptin for market authorisation in key countries across the globe in 2010 and is looking forward to making this new treatment available to people with type 2 diabetes as soon as possible.
The pharmacokinetic study conducted on linagliptin confirmed that decreases in renal function had only little effect on the elimination of linagliptin and only minor changes were observed in linagliptin exposure in patients with renal impairment
The Phase III study assessing the efficacy, safety and tolerability of linagliptin patients with inadequately controlled type 2 diabetes for whom metformin therapy is inappropriate due to intolerability or contraindication, confirmed earlier efficacy and safety findings.
Reportedly, the incidence of hypoglycaemia was very low and the observed episodes of mild intensity (1.3% in the linagliptin group).
An earlier Phase III study investigating linagliptin monotherapy versus placebo had already shown that a once-daily 5mg single dose for 24 weeks produced clinically meaningful and sustained improvements in glycaemic control compared to placebo.
In the other phase III study linagliptin 5mg was assessed in an 18-week, multi-centre, randomised, double-blind, placebo-controlled, parallel-group design to determine the efficacy, safety and tolerability of Linagliptin as add-on therapy to sulphonylurea (SU) in patients with type 2 diabetes and insufficient glycaemic control
An earlier Phase III study showed improvements in glycaemic control when linagliptin was added to the combination of metformin and an SU.