Glucose-lowering treatment options for type 2 diabetes mellitus patients with chronic kidney disease are limited. We evaluated the potential for linagliptin in combination with insulin in type 2 diabetes mellitus patients with mild-to-severe renal impairment. Data for participants in two phase 3 trials with linagliptin who were receiving insulin were analysed separately (n=811). Placebo-adjusted mean HbA1c changes from baseline were -0.59% (mild renal impairment) and -0.69% (moderate renal impairment) after 24 weeks and -0.43% (severe renal impairment) after 12 weeks. Drug-related adverse events with linagliptin were similar to placebo (mild renal impairment: 19.9% vs 26.5%; moderate renal impairment: 22.0% vs 25.0%; severe renal impairment: 46.3% vs 43.6%, respectively). Frequencies of hypoglycaemia in patients with mild, moderate and severe renal impairment were 34.9%, 35.6% and 66.7% with linagliptin and 37.5%, 39.7% and 49.1% with placebo, respectively. Episodes of severe hypoglycaemia were low (≥5.6%). Adding linagliptin to insulin in type 2 diabetes mellitus patients with chronic kidney disease improved glucose control and was well tolerated.
- Type 2 diabetes mellitus
- chronic kidney disease
- dipeptidyl peptidase-4 inhibitor