The drug sitagliptin (Januvia) has been authorised by the Medicines and Healthcare products Regulatory Agency for use in type 2 diabetes patients with moderate to severe renal impairment.
The new indication is based on favourable results from trials involving diabetes patients with moderate to severe renal impairment and diabetes patients with end-stage renal disease on dialysis.
Sitagliptin is manufactured by Merck Sharp & Dohme. It said in patients with moderate to severe renal impairment, a study comparing sitagliptin at 25 or 50mg once daily with glipizide at 2.5-20mg per day showed a mean reduction in HbA1c of 0.76% with sitagliptin and 0.64% with glipizide after 54 weeks.
In patients with ESRD on dialysis, the company said trial results showed treatment with sitagliptin 25mg once daily for 54 weeks provided “clinically meaningful” reductions from baseline in HbA1c (0.72% with sitagliptin versus 0.87% with glipizide).