Date: 2011-11-07
Type of information:
phase: 3a
Announcement: Results
Company: Novo Nordisk (Denmark)
Product: DegludecPlus
Action mechanism: Degludec (insulin degludec) is an ultra-long-acting basal insulin analogue discovered and developed by Novo Nordisk. DegludecPlus (insulin degludec/insulin aspart) contains the ultra-long-acting basal insulin Degludec in a formulation with a bolus boost of insulin aspart.
Disease: type 2 diabetes
Therapeutic area: Metabolic diseases
Country: Japan
Trial details:
Latest
news: Novo Nordisk has announced clinical results from a 26-week phase 3a treat-to-target study comparing DegludecPlus, a soluble combination of ultra-long-acting insulin degludec and insulin aspart, to insulin glargine in Japanese people with type 2 diabetes inadequately controlled on oral antidiabetic drugs. In this 26-week phase 3a study, 296 Japanese people with type 2 diabetes were randomised 1:1 to treatment with either DegludecPlus or insulin glargine, both given once daily with or without OADs. DegludecPlus lowered the long-term glycaemic control, HbA1c, by around 1.4 percentage points to 7.0%, which was statistically significantly superior to the reduction seen with insulin glargine, with an estimated treatment difference of 0.3 percentage point. In addition to achieving superiority in glucose control, DegludecPlus treatment was accompanied with a trend of lower risk of hypoglycaemia; the rate of confirmed hypoglycaemic episodes was 27% lower with DegludecPlus than with insulin glargine. The rate of confirmed nocturnal hypoglycaemic episodes was 25% lower with DegludecPlus compared to insulin glargine. Confirmed hypoglycaemia is defined as a plasma glucose level below 3.1 mmol/l or need for third party assistance. DegludecPlus demonstrated a good safety and tolerability profile and there were no apparent differences between the treatment groups with respect to adverse events and standard safety parameters.
