AstraZeneca PLC — Komboglyze EMA EPAR variation assessment report (EMEA/H/C/002059, 2011)
AstraZeneca PLC · 2011 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the assessment of a prematurely terminated pediatric study (CV181153) for Komboglyze (saxagliptin/metformin hydrochloride), submitted to the EMA. The Phase 1 pharmacokinetic study in adolescents with Type 2 Diabetes Mellitus was a post-marketing requirement by the FDA. However, due to limited enrollment and early termination, the study's contribution to general pediatric knowledge of saxagliptin and metformin is considered very limited.
Key findings — cited to the page
| Study phase | Phase 1 | CV181153 · p.4 |
| Planned enrollment | 12 patients | CV181153 · p.4 |
| Enrolled subjects | 4 subjects | CV181153 · p.5 |
| Subjects received study drug | 2 subjects | CV181153 · p.5 |
| Subjects completed study | 2 subjects | CV181153 · p.5 |
| Adverse event rate (headache) | 2 subjects | CV181153 · p.5 |
Source: AstraZeneca PLC ↗ · 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 →