Therapeutic options are limited for diabetes patients with renal disease. This report presents 52-week results from a study assessing the dipeptidyl peptidase-4 inhibitor saxagliptin in patients with type 2 diabetes mellitus (T2DM) and renal impairment.Design:
Double-blind study in patients stratified by baseline renal impairment (moderate, severe or end-stage renal disease [ESRD] on haemodialysis) randomised to saxagliptin 2.5 mg once daily or placebo added to other antidiabetic drugs in use at baseline, including insulin.Patients:
A total of 170 adults with glycated haemoglobin (HbA1c) 7–11% and creatinine clearance < 50 ml/min or ESRD were randomised and treated.Measurements:
Absolute changes in HbA1c and fasting plasma glucose (FPG) from baseline to week 52 were evaluated using analysis of covariance (ANCOVA) with last observation carried forward. Repeated-measures analyses were also performed.Results:
Adjusted mean decrease in HbA1c was greater with saxagliptin than placebo (difference, −0.73%, p < 0.001 [ANCOVA]). Reductions in adjusted mean HbA1c were numerically greater with saxagliptin than placebo in patients with renal impairment rated as moderate (−0.94% vs. 0.19% respectively) or severe (−0.81% vs. −0.49%), but similar to placebo for those with ESRD (−1.13% vs. −0.99%). Reductions in adjusted mean FPG were numerically greater with saxagliptin in patients with moderate or severe renal impairment. Saxagliptin was generally well tolerated; similar proportions of patients in the saxagliptin and placebo groups reported hypoglycaemic events (28% and 29% respectively).Conclusions:
Saxagliptin 2.5 mg once daily offers sustained efficacy and good tolerability for patients with T2DM and renal impairment.