Novo Nordisk A S — Tresiba EMA EPAR public assessment report (EMEA/H/C/002498, 2013)
Novo Nordisk A S · 2013 · EMA EPAR public assessment report · company profile →
Report summary
The EMA EPAR for Tresiba (insulin degludec) details its regulatory approval, non-clinical and clinical development. Submitted by Novo Nordisk A/S in 2011, it received a positive CHMP opinion in 2012. Tresiba, a long-acting insulin, demonstrated a prolonged pharmacokinetic profile and efficacy in Type 1 and Type 2 diabetes, with a flatter glucose-lowering effect and lower day-to-day variability than insulin glargine. Clinical trials (41 total, 5624 subjects) confirmed non-inferiority in HbA1c reduction compared to comparators, and significantly reduced nocturnal confirmed hypoglycemic episodes, particularly in Type 2 diabetes. Safety profiles were generally similar to other insulin analogues, with specific attention to potential medication errors between 100 U/mL and 200 U/mL formulations.
Key findings — cited to the page
| CHMP positive opinion date | 18 October 2012 | Tresiba · EU · p.7 |
| Number of subjects randomized to IDeg OD in T1DM therapeutic confirmatory trials | 1104 | Tresiba (IDeg) · Global · p.41 |
| Number of subjects randomized to comparator products in T1DM therapeutic confirmatory trials | 474 | Tresiba (IDeg) · Global · p.41 |
| Percentage of T1DM subjects exposed to comparator in therapeutic confirmatory trials | 98.5 % | Tresiba (IDeg) · p.45 |
| Total number of subjects randomized in T1DM therapeutic confirmatory trials | 1578 | Tresiba (IDeg) · Global · p.41 |
| Number of subjects randomized to IDeg OD in T2DM therapeutic confirmatory trials | 2733 | Tresiba (IDeg) · Global · p.41 |
| Number of subjects randomized to comparator products in T2DM therapeutic confirmatory trials | 1343 | Tresiba (IDeg) · Global · p.41 |
| Total number of subjects randomized in T2DM therapeutic confirmatory trials | 4076 | Tresiba (IDeg) · Global · p.41 |
| HbA1c limits for Trial 3580 | 7.5-11.0 % | Tresiba (IDeg) · p.42 |
| HbA1c limits for insulin-naïve subjects in Trial 3668 | 7.0-11.0 % | Tresiba (IDeg) · p.42 |
| Upper HbA1c limit for trials where OADs were discontinued at randomisation | 10 % | Tresiba (IDeg) · p.42 |
| Marketing Authorisation application submission date | 26 September 2011 | Tresiba · EU · p.5 |
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 →