Boehringer Ingelheim — Trajenta EMA EPAR variation assessment report (EMEA/H/C/002110, 2011)
Boehringer Ingelheim · 2011 · EMA EPAR variation assessment report
Report summary
This report summarizes a Type II variation application for Trajenta (linagliptin) to update product information for pediatric use. The application, based on the Phase III DINAMO study (1218-0091), evaluated linagliptin's efficacy and safety in children and adolescents with type 2 diabetes. While pharmacokinetic analyses suggested comparability between pediatric and adult patients, linagliptin 5 mg did not achieve a statistically significant or clinically relevant HbA1c reduction in adolescents. Although a dose-finding study showed some HbA1c reduction, the primary Phase III trial failed to demonstrate efficacy. Safety profiles were comparable to placebo, with slightly higher hypoglycemia in the linagliptin group. Consequently, the benefit-risk balance for linagliptin in the pediatric population was deemed negative, despite remaining positive for adults. Regulatory concerns included long-term sample stability and clarity of pharmacokinetic data in the SmPC.
Key findings — cited to the page
| Number of treatment arms | 3 | DINAMO 1218-0091 · p.4 |
| Empagliflozin dose increase | 25 mg | DINAMO 1218-0091 · p.4 |
| Safety extension duration | 52 weeks | DINAMO 1218-0091 · p.3 |
| Trial population age range | 10 to <=17 years | DINAMO 1218-0091 · p.4 |
| Linagliptin dose | 5 mg | DINAMO 1218-0091 · p.4 |
| Empagliflozin dose | 10 mg | DINAMO 1218-0091 · p.4 |
| Benefit-risk balance for adults | positive | Trajenta · p.4 |
| Trial Phase | Phase III | DINAMO 1218-0091 · p.3 |
| Procedure Number | EMEA/H/C/002110/II/0049 | Trajenta · p.1 |
| Application submission date | 14 December 2022 | · p.3 |
| Trial duration | 26 weeks | DINAMO 1218-0091 · p.3 |
| Number of patients randomized to linagliptin | 53 | DINAMO 1218-0091 · p.4 |
Source: Boehringer Ingelheim ↗ · 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 →