faster aspart

Metabolic· 219 cited findings· 1 source document

What the regulatory reviews say

Faster aspart is an insulin aspart formulation indicated for the treatment of diabetes. In a run-in phase, mealtime faster aspart showed an HbA1c change from 7.76% to 7.57%, while post-meal faster aspart showed a change from 7.71% to 7.58%. The comparator, NovoRapid/NovoLog, demonstrated an HbA1c change from 7.67% to 7.53% in the run-in phase. The estimated treatment difference in HbA1c for mealtime faster aspart versus NovoRapid was -0.17%. The odds ratio for achieving an HbA1c target of < 7.5% for mealtime faster aspart versus NovoRapid/NovoLog was 1.33.

Regarding safety, the proportion of subjects experiencing an adverse event ranged from 73.9% to 78.7%. The AE rate was observed between 448.6 and 531.1 per 100 PYE. The proportion of subjects with severe adverse events ranged from 1.1% to 2.7%. A total of 15 serious adverse events were reported. Faster aspart has been approved and launched.

Key figures — cited to the source page

HbA1c change from baseline (run-in, mealtime faster aspart)	from 7.76% to 7.57%	Novo Nordisk A S — Tresiba EMA EPAR variation assessment rep, p.18
HbA1c change from baseline (run-in, mealtime NovoRapid/NovoLog)	from 7.67% to 7.53%	Novo Nordisk A S — Tresiba EMA EPAR variation assessment rep, p.18
Estimated treatment difference in HbA1c (mealtime faster aspart vs NovoRapid)	-0.17	Novo Nordisk A S — Tresiba EMA EPAR variation assessment rep, p.23
Odds Ratio for achieving HbA1c target (< 7.5%) (mealtime faster aspart vs NovoRapid/NovoLog)	1.33	Novo Nordisk A S — Tresiba EMA EPAR variation assessment rep, p.23
Proportion of subjects with an AE	73.9	Novo Nordisk A S — Tresiba EMA EPAR variation assessment rep, p.30
AE rate	448.6	Novo Nordisk A S — Tresiba EMA EPAR variation assessment rep, p.30
Number of SAEs	15	Novo Nordisk A S — Tresiba EMA EPAR variation assessment rep, p.34
Approval status	approved and launched	Novo Nordisk A S — Tresiba EMA EPAR variation assessment rep, p.4

Source documents

Novo Nordisk A S — Tresiba EMA EPAR variation assessment report (EMEA/H/C/002498, 2013) (2013)

Explore the full evidence

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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.