Aims
Renal disease is a frequent comorbidity of type 2 diabetes mellitus (T2DM) and an important factor complicating the choice of glucose‐lowering drugs. The aim of this analysis was to evaluate the efficacy and safety of the dipeptidyl peptidase (DPP)‐4 inhibitor linagliptin (5 mg/day) in mono, dual or triple oral glucose‐lowering regimens in subjects with T2DM and mild or moderate renal impairment (RI).
Methods
In this pooled analysis of three 24‐week, placebo‐controlled, phase 3 trials, subjects with mild (estimated glomerular filtration rate (eGFR) 60–<90 ml/min/1.73 m2, n = 838) or moderate RI (30–<60 ml/min/1.73 m2, n = 93) were compared with subjects with normal renal function (≥90 ml/min/1.73 m2, n = 1212).
Results
Subjects with RI were older, had longer duration of diabetes, and increased prevalence of diabetes‐related comorbidities. After 24 weeks, linagliptin achieved consistent placebo‐corrected mean glycated haemoglobin (HbA1c) changes across the three renal function categories: normal (−0.63%; p < 0.0001), mild RI (−0.67%; p < 0.0001) and moderate RI (−0.53%; p < 0.01), with no inter‐group difference (p = 0.74). Renal function with linagliptin remained stable across all categories. In linagliptin‐treated subjects, overall adverse event (AE) rates and serious AE rates were similar to placebo. The incidence of hypoglycaemia with linagliptin and placebo was 11.1 versus 6.9%, 11.9 versus 9.0% and 15.9 versus 12.0% in the normal, mild RI and moderate RI categories, respectively.
Conclusions
This pooled analysis provides evidence that linagliptin is an effective, well‐tolerated and convenient treatment in subjects with T2DM and mild or moderate RI.