Long-term 4-year safety of saxagliptin in drug-naive and metformin-treated patients with Type 2 diabetes

AimsTo evaluate the safety of saxagliptinmetformin over 4years in patients with Type2 diabetes mellitus. MethodsDrug-naive (n=401; study11) or metformin-treated (n=743; study14) adults with HbA(1c) of 53-86mmol/mol (7.0-10%) were enrolled in two randomized, placebo-controlled, double-blind trials of saxagliptin 2.5, 5 or 10mg/day. Patients rescued during or completing 24weeks of treatment could continue in a 42-month long-term blinded phase, for which the primary goal was assessment of safety and tolerability. Between-group efficacy was not evaluated in the long-term phase of study11. Time to rescue or discontinuation because of inadequate glycaemic control, change from baseline in HbA(1c) and percentages of patients achieving HbA(1c) <53mmol/mol (<7.0%) were assessed in study14. ResultsNo new safety findings were noted during the long-term phase. Most adverse events were mild or moderate, with slightly greater frequency of upper respiratory infections with saxagliptin. Hypoglycaemic event rates were similar with saxagliptin and placebo. In study14, time to rescue or discontinuation because of inadequate glycaemic control was longer with saxagliptin plus metformin than for placebo plus metformin. From baseline to week154, HbA(1c) decreased with saxagliptin but increased with placebo. ConclusionSaxagliptin monotherapy or add-on to metformin is generally safe and well tolerated, with no increased risk of hypoglycaemia, for up to 4years.