To explore the clinical use of SAXA in patients with renal impairment, a multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week study conducted to the assess the efficacy and safety of SAXA 2.5 mg/day in adult patients with T2DM, HbA
1c 7%-11%, and moderate (estimated creatinine clearance ≥0.50 to <0.84 mL/s) to severe (creatinine clearance <0.50 mL/s) renal impairment, including end-stage renal disease (ESRD) with hemodialysis [
6]. Patients (96%) continued background oral antidiabetic (32%) and/or insulin (74%) therapy as prescribed. The results, which were presented by Nowicki et al at ADA, showed that the overall mean reduction in HbA
1c from baseline to week 12 for patients with renal impairment was significantly greater with SAXA versus placebo. Subgroup results by baseline renal impairment category showed numerically greater reductions in HbA
1c with SAXA versus placebo in patients with moderate or severe renal impairment, while the HbA
1c reduction in patients with ESRD on hemodialysis was similar between the treatment groups. SAXA was well tolerated, with a safety profile similar to placebo (adverse events were experienced by 57.6% of patients in the SAXA group, compared with 54.1% in the placebo group; hypoglycemia was reported in 20.0% of SAXA patients vs 22.4% of placebo patients) [
6]. Based on these results, SAXA could also be considered as the antidiabetic drug in patients with moderate or severe renal impairment, where insulin is usually the drug of choice and MET is contraindicated, although it is not recommended for patients with ESRD on hemodialysis.