Novo Nordisk A S — Tresiba EMA EPAR variation assessment report (EMEA/H/C/002498, 2013)
Novo Nordisk A S · 2013 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes pediatric studies evaluating faster aspart (Fiasp) with insulin degludec (Tresiba) in children and adolescents with Type 1 Diabetes. The primary study (NN1218-4101) was a 26-week, randomized, partly double-blind trial comparing mealtime Fiasp to NovoRapid, both with Tresiba. The study confirmed non-inferiority of mealtime Fiasp to NovoRapid for HbA1c change from baseline, with mealtime Fiasp demonstrating superiority. Safety profiles were generally consistent with known product information, though a higher incidence of severe hypoglycemia was observed in younger children receiving faster aspart, and higher nocturnal hypoglycemia in the post-meal faster aspart group. The report details efficacy and safety outcomes, including HbA1c, postprandial glucose, and hypoglycemia rates across different age groups and treatment arms.
Key findings — cited to the page
| Non-inferiority margin (HbA1c) | 0.4 % | NN1218-4101 · p.9 |
| Enrolment N (run-in) | 834 subjects | NN1218-4101 · p.10 |
| Randomised N | 777 subjects | NN1218-4101 · p.10 |
| Randomised N (mealtime faster aspart) | 260 subjects | NN1218-4101 · p.10 |
| Randomised N (post-meal faster aspart) | 259 subjects | NN1218-4101 · p.10 |
| Randomised N (NovoRapid/NovoLog) | 258 subjects | NN1218-4101 · p.10 |
| Completion rate | 97.8 % | NN1218-4101 · p.10 |
| Completion rate (mealtime faster aspart) | 98.5 % | NN1218-4101 · p.10 |
| Completion rate (post-meal faster aspart) | 96.9 % | NN1218-4101 · p.10 |
| Completion rate (NovoRapid/NovoLog) | 98.1 % | NN1218-4101 · p.10 |
| Premature discontinuation rate | 2.7 % | NN1218-4101 · p.12 |
| Subjects enrolled from US | 25.1 % | NN1218-4101 · United States · p.13 |
Source: Novo Nordisk A S ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →