Boehringer Ingelheim — Jentadueto EMA EPAR variation assessment report (EMEA/H/C/002279, 2012)
Boehringer Ingelheim · 2012 · EMA EPAR variation assessment report
Report summary
This report summarizes a Type II variation application for Jentadueto (linagliptin/metformin) to update product information based on pediatric study results. Pharmacokinetic (PK) analysis of linagliptin in children and adolescents with type 2 diabetes showed comparability to adults, but a smaller HbA1c reduction effect. Two pediatric trials, 1218.91 (DINAMO) and 1218.56, investigated linagliptin. Trial 1218.56, a Phase IIb study, demonstrated dose-dependent HbA1c and FPG reductions. However, the larger Phase III trial 1218.91 did not show a statistically significant HbA1c reduction with linagliptin 5 mg in its primary analysis, although Bayesian analysis suggested efficacy. Safety profiles were generally comparable to placebo, with a higher incidence of hypoglycemia, though not typically symptomatic or severe.
Key findings — cited to the page
| CHMP Rapporteur Assessment Report | 30 Jan 2024 | · p.2 |
| Opinion | 22 Feb 2024 | · p.2 |
| Application submission date | 17 November 2023 | · p.4 |
| Trial phase | Phase IIb | 1218.56 · p.4 |
| Trial duration | 12 weeks | 1218.56 · p.4 |
| Age range | 10 to ≤17 years | 1218.56 · p.4 |
| Trial arms | linagliptin 1 mg, linagliptin 5 mg, placebo | 1218.56 · p.4 |
| Trial phase | Phase III | 1218.91 · p.4 |
| Trial duration | 26 weeks | 1218.91 · p.4 |
| HbA1c reduction | not relevant | 1218.91 · p.4 |
| Benefit-risk balance | negative | Jentadueto · p.5 |
| Start of procedure | 25 Dec 2023 | · p.2 |
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 →