9 research outputs found
The effect of insulin degludec on risk of symptomatic nocturnal hypoglycaemia in adults with type 1 diabetes and high risk of nocturnal severe hypoglycaemia (the HypoDeg trial):study rationale and design
Continuous Glucose Monitoring-Recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia
Comparison of treatment with insulin degludec and glargine U100 in patients with type 1 diabetes prone to nocturnal severe hypoglycaemia:The HypoDeg randomized, controlled, open-label, crossover trial
AIM: To investigate whether the longâacting insulin analogue insulin degludec compared with insulin glargine U100 reduces the risk of nocturnal symptomatic hypoglycaemia in patients with type 1 diabetes (T1D). METHODS: Adults with T1D and at least one episode of nocturnal severe hypoglycaemia during the last 2âyears were included in a 2âyear prospective, randomized, open, multicentre, crossover trial. A total of 149 patients were randomized 1:1 to basalâbolus therapy with insulin degludec and insulin aspart or insulin glargine U100 and insulin aspart. Each treatment period lasted 1âyear and consisted of 3âmonths of runâin or crossover followed by 9âmonths of maintenance. The primary endpoint was the number of blindly adjudicated nocturnal symptomatic hypoglycaemic episodes. Secondary endpoints included the occurrence of severe hypoglycaemia. We analysed all endpoints by intentionâtoâtreat. RESULTS: Treatment with insulin degludec resulted in a 28% (95% CI: 9%â43%; P = .02) relative rate reduction (RRR) of nocturnal symptomatic hypoglycaemia at level 1 (â¤3.9âmmol/L), a 37% (95% CI: 16%â53%; P = .002) RRR at level 2 (â¤3.0âmmol/L), and a 35% (95% CI: 1%â58%; P = .04) RRR in allâday severe hypoglycaemia compared with insulin glargine U100. CONCLUSIONS: Patients with T1D prone to nocturnal severe hypoglycaemia have lower rates of nocturnal symptomatic hypoglycaemia and allâday severe hypoglycaemia with insulin degludec compared with insulin glargine U100