Boehringer Ingelheim — Jentadueto EMA EPAR public assessment report (EMEA/H/C/002279, 2012)
Boehringer Ingelheim · 2012 · EMA EPAR public assessment report
Report summary
This EMA EPAR report details the regulatory assessment of Jentadueto (linagliptin/metformin hydrochloride) for type 2 diabetes. It covers the product's composition, manufacturing, and extensive non-clinical and clinical development. Non-clinical studies confirmed acceptable quality and safety, with no new concerns beyond individual components. The clinical program, including Phase I, II, and III trials, established bioequivalence, optimal dosing, and additive glycemic control. Efficacy studies consistently demonstrated significant reductions in HbA1c and FPG across various regimens and patient populations. Safety assessments highlighted a generally favorable profile, with key considerations for hypoglycemia, pancreatic disorders, and cardiovascular safety, leading to its approval for type 2 diabetes treatment.
Key findings — cited to the page
| Linagliptin DPP-4 inhibition (>=25 mg single dose) | >95 % | · p.64 |
| Linagliptin DPP-4 inhibition (5 mg single dose) | 88.5 % | · p.64 |
| Linagliptin steady-state AUC increase with metformin | 20 % | · p.63 |
| Number of subjects aged 10-12 years in metformin clinical studies | 15 | · p.62 |
| Linagliptin exposure increase in combination with metformin (population pharmacokinetic analysis) | 19.8 % | · p.63 |
| Linagliptin DPP-4 inhibition (2.5 mg single dose) | 72 % | · p.64 |
| Linagliptin solubility in aqueous media | > 1 mg/ml | Linagliptin · p.9 |
| Linagliptin (Trajenta 5mg) EU Marketing Authorisation date | 24 August 2011 | Trajenta · EU · p.7 |
| Linagliptin monotherapy clinical development program | 24 phase I studies, 4 phase II and 9 phase III studies | Linagliptin · p.8 |
| Total cholesterol (TC) levels decrease (metformin) | 10 % | · p.67 |
| Linagliptin/Metformin FDC clinical development program | 6 phase I, 2 phase II and 4 phase III studies | Jentadueto · p.8 |
| Linagliptin DPP-4 inhibition at steady-state (5 mg or 10 mg once daily) | >80 % | · p.64 |
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 →