Ristfor
Metabolic· 79 cited findings· 2 source documents
Company: Merck & Co., Inc. →
What the regulatory reviews say
Ristfor is a drug for which a Marketing Authorisation application was submitted on 2 October 2009, with a CHMP positive opinion date of 17 December 2009. The legal basis for this application was Article 10(c) of Directive 2001/83/EC. Related Marketing Authorisations for Janumet, Velmetia, and Efficib were granted on 16 July 2008.
In efficacy studies, the difference in HbA1c change from baseline between sitagliptin and placebo was -0.2%. A1C reduction superiority was met in some instances and not met in others, including for Sita/Met FDC versus Metformin. The dose-adjusted AUC0-∞ of sitagliptin was 18% lower. A1C improvement was no longer observed in some assessments.
Safety findings include 1 death in the Sita/Met FDC group. Severe hypoglycemia occurred in <=3 subjects in the Sita/Met FDC group (not on insulin) and <=3 subjects in the Metformin group (not on insulin). One subject in both the Sita/Met FDC group (on insulin) and the Metformin group (on insulin) experienced severe hypoglycemia. One subject had an ALT value >10x ULN. Postmarketing reports for adults totaled 26,843, with 13,081 serious AEs, including 751 pancreatitis SAEs and 415 diabetes mellitus inadequate control SAEs.
Key figures — cited to the source page
| Difference in HbA1c change from baseline (sitagliptin vs placebo) | -0.2 | Ristfor EMA EPAR variation assessment re, p.5 |
| A1C reduction superiority (Sita/Met FDC vs Metformin) | not met | Ristfor EMA EPAR variation assessment re, p.11 |
| Death in Sita/Met FDC group | 1 | Ristfor EMA EPAR variation assessment re, p.4 |
| Severe hypoglycemia in Sita/Met FDC group (not on insulin) | <=3 | Ristfor EMA EPAR variation assessment re, p.5 |
| ALT value >10x ULN | 1 | Ristfor EMA EPAR variation assessment re, p.23 |
| Postmarketing reports (adults) | 26843 | Ristfor EMA EPAR variation assessment re, p.24 |
| Marketing Authorisation application submission date | 2 October 2009 | Ristfor EMA EPAR public assessment repor, p.3 |
| CHMP positive opinion date | 17 December 2009 | Ristfor EMA EPAR public assessment repor, p.4 |
Source documents
Explore the full evidence
All 79 cited findings for Ristfor — searchable, comparable and answerable in plain language — are in the Metabolic research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.