http://www.sys-con.com/node/2052614
Novo Nordisk A/S: DegludecPlus provides superior glycaemic control compared to insulin glargine in a phase 3a trial in Japanese people with type 2 diabetes
Novo Nordisk today announced clinical results from a 26-week phase 3a treatto-target study comparing DegludecPlus, a soluble combination of ultra-longacting insulin degludec and insulin aspart, to insulin glargine in Japanese people with type 2 diabetes inadequately controlled on oral antidiabetic drugs. This is the 18th announced phase 3a study in the Degludec and DegludecPlus clinical trial development programme.
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 longterm 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
Novo Nordisk A/S: DegludecPlus provides superior glycaemic control compared to insulin glargine in a phase 3a trial in Japanese people with type 2 diabetes
Novo Nordisk today announced clinical results from a 26-week phase 3a treatto-target study comparing DegludecPlus, a soluble combination of ultra-longacting insulin degludec and insulin aspart, to insulin glargine in Japanese people with type 2 diabetes inadequately controlled on oral antidiabetic drugs. This is the 18th announced phase 3a study in the Degludec and DegludecPlus clinical trial development programme.
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 longterm 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