Merck & Co., Inc. — Ristfor EMA EPAR variation assessment report (EMEA/H/C/001235, 2010)
Merck & Co., Inc. · 2010 · EMA EPAR variation assessment report · company profile →
Report summary
Merck Sharp & Dohme B.V. submitted a Type II variation for sitagliptin/metformin FDCs (Ristfor, Efficib, Velmetia, Janumet) based on pooled pediatric studies (P170, P289) in Type 2 Diabetes Mellitus. While a 20-week pooled analysis showed sitagliptin/metformin superiority in A1C reduction, this was not sustained at Week 54, and individual study results were inconsistent. Efficacy was deemed insufficient, potentially due to lower sitagliptin exposure in pediatric patients. The FDC was generally well-tolerated, with similar adverse event rates to metformin alone, but an increased risk of hypoglycemia was observed with sitagliptin, especially with background insulin. The CHMP recommended approval of the variation to update the SmPC, reflecting insufficient pediatric efficacy and increased hypoglycemia risk.
Key findings — cited to the page
| Mean age of subjects | 14.4 years | Studies P170 and P289 · p.4 |
| Percentage of subjects aged >=10 and <15 years | 44.5 % | Studies P170 and P289 · p.4 |
| Percentage of female subjects | 65.9 % | Studies P170 and P289 · p.4 |
| Baseline mean A1C | 8.0 % | Studies P170 and P289 · p.4 |
| Baseline mean BMI | 30.9 kg/m2 | Studies P170 and P289 · p.4 |
| Percentage of subjects on background metformin >1500 mg/day | 71.8 % | Studies P170 and P289 · p.4 |
| Percentage of subjects on background insulin therapy | 15.0 % | Studies P170 and P289 · p.4 |
| Number of randomized and treated subjects | 220 | Studies P170 and P289 · p.4 |
| Number of subjects in Sita/Met FDC group | 107 | Studies P170 and P289 · p.4 |
| Number of subjects in Metformin group | 113 | Studies P170 and P289 · p.4 |
| Death in Sita/Met FDC group | 1 | Studies P170 and P289 · p.4 |
| Variation type | Type II | · p.3 |
Source: Merck & Co., Inc. ↗ · 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 →