Takeda Pharmaceutical Company Limited — Vipidia EMA EPAR variation assessment report (EMEA/H/C/002182, 2013)
Takeda Pharmaceutical Company Limited · 2013 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the assessment of a pediatric study for alogliptin (Vipidia) in Type 2 Diabetes Mellitus. The study, involving 151 subjects aged 10-17, compared 25 mg alogliptin once daily to placebo. The primary endpoint, HbA1c change from baseline at Week 26, showed no statistically significant difference between the groups. Consequently, a negative benefit-risk assessment was concluded for alogliptin in pediatric patients.
Key findings — cited to the page
| Comparator | placebo | · p.4 |
| Background therapy | monotherapy, metformin alone, insulin alone, or combination of metformin and insulin | · p.4 |
| Population | pediatric subjects with Type 2 diabetes mellitus | · p.5 |
| Primary endpoint | HbA1c change from baseline at Week 26 | · p.5 |
| Study phase | 3 | · p.5 |
| Age range | 10 to 17 years | · p.5 |
| Randomization ratio | 1:1 | · p.6 |
| Enrolled subjects | 152 subjects | · p.6 |
| Safety analysis set | 151 subjects | · p.6 |
| Full analysis set (FAS) | 151 subjects | · p.6 |
| Per protocol analysis set (PPS) | 45 subjects | · p.6 |
| Influenza incidence (alogliptin) | 9.3 % | · p.15 |
Source: Takeda Pharmaceutical Company Limited ↗ · 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 →