Merck & Co., Inc. — Ristaben EMA EPAR variation assessment report (EMEA/H/C/001234, 2010)
Merck & Co., Inc. · 2010 · EMA EPAR variation assessment report · company profile →
Report summary
This report assesses a 5-year observational follow-up study (P351) on sitagliptin in pediatric patients (10-17 years) with Type 2 Diabetes Mellitus (T2DM), who previously participated in a Phase III trial (P083). The study's primary objective was to evaluate long-term safety. No new safety concerns were identified during the follow-up period. As an observational study, it did not include efficacy data.
Key findings — cited to the page
| Approval year in EU for Januvia | 2007 | Januvia · EU · p.3 |
| Study P083 duration | 54 weeks | MK-0431 Protocol 083 (P083) · p.4 |
| Study P351 duration | 5 years | MK-0431 Protocol 351 (P351) · p.4 |
| Mean A1C at baseline in MK-0431-083 | 7.5 % | MK-0431-083 · p.5 |
| Number of participants in MK-0431-351 (Exposed to Sitagliptin in P083) | 36 | MK-0431-351 (P351) · p.6 |
| Percentage of participants aged ≥10 and <15 years in MK-0431-351 | 40.0 % | MK-0431-351 (P351) · p.6 |
| Percentage of participants aged ≥15 and <18 years in MK-0431-351 | 45.0 % | MK-0431-351 (P351) · p.6 |
| Number of study sites for MK-0431A-170 | 100 | MK-0431A-170 · p.5 |
| P-value for A1C reduction at Week 20 (placebo-adjusted difference) | 0.448 | MK-0431-083 · p.5 |
| Number of study sites for MK-0431-081 | 7 | MK-0431-081 · p.5 |
| Number of participants in MK-0431-081 (Sitagliptin 50 mg) | 9 | MK-0431-081 · p.5 |
| Number of participants in MK-0431-351 (Not Exposed in P083) | 44 | MK-0431-351 (P351) · p.6 |
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 →