Ryzodeg(IDegAsp)

Metabolic· 1416 cited findings· 2 source documents

What the regulatory reviews say

Ryzodeg (IDegAsp) is indicated for the treatment of diabetes mellitus in adults. It was qualified as a new active substance and received a favourable CHMP recommendation for marketing authorisation on October 18, 2012, leading to EU approval on January 21, 2013.

In terms of efficacy, Ryzodeg demonstrated significantly lower day-to-day variability in glucose-lowering effect compared to insulin glargine (IGlar). For instance, the day-to-day variability in glucose-lowering effect (AUCGIR,τ,SS) was 20% for IDegAsp versus 82% for IGlar (p-value <0.0001). Similarly, the day-to-day variability in glucose-lowering effect (AUCGIR,2-24h,SS) was 22% for IDegAsp compared to 92% for IGlar (p-value <0.0001). The day-to-day variability in glucose-lowering effect (GIRmax,SS) was 18% for IDegAsp versus 60% for IGlar (p-value <0.0001).

Safety findings indicate a lower risk of extreme effects with IDegAsp. The risk of experiencing less than half the usual average effect (potential hyperglycaemia) was <0.1% for IDegAsp, compared to 17% for IGlar. The risk of experiencing more than 1.5 times the usual average effect (potential hypoglycaemia) was 2% for IDegAsp, versus 29% for IGlar. The observed rate of nocturnal confirmed hypoglycaemic episodes for IDegAsp was 371 per 100 PYE, with a rate ratio of 0.63 when compared to insulin detemir (IDet).

Key figures — cited to the source page

Day-to-day variability in glucose-lowering effect (AUCGIR,τ,SS) (CV%)	20	Novo Nordisk A S — Ryzodeg EMA EPAR public assessment report, p.37
Day-to-day variability in glucose-lowering effect (AUCGIR,τ,SS) for comparator IGlar (CV%)	82	Novo Nordisk A S — Ryzodeg EMA EPAR public assessment report, p.37
p-value for difference in AUCGIR,τ,SS variability	<0.0001	Novo Nordisk A S — Ryzodeg EMA EPAR public assessment report, p.37
Risk of experiencing less than half the usual average effect (potential hyperglycaemia) for IDeg	<0.1	Novo Nordisk A S — Ryzodeg EMA EPAR public assessment report, p.38
Risk of experiencing less than half the usual average effect (potential hyperglycaemia) for IGlar	17	Novo Nordisk A S — Ryzodeg EMA EPAR public assessment report, p.38
Risk of experiencing more than 1.5 times the usual average effect (potential hypoglycaemia) for IDeg	2	Novo Nordisk A S — Ryzodeg EMA EPAR public assessment report, p.38
Risk of experiencing more than 1.5 times the usual average effect (potential hypoglycaemia) for IGlar	29	Novo Nordisk A S — Ryzodeg EMA EPAR public assessment report, p.38
IDegAsp approval in adults (EU)	21 January 2013	Novo Nordisk A S — Ryzodeg EMA EPAR variation assessment rep, p.7

Source documents

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.