Ristaben
Metabolic· 75 cited findings· 2 source documents
Company: Merck & Co., Inc. →
What the regulatory reviews say
Ristaben is a drug for which a CHMP positive opinion was issued on 17 December 2009. The Marketing Authorisation application was submitted on 2 October 2009, following CHMP agreement on centralised procedure eligibility on 23 July 2009. Related drugs, Januvia and Xelevia, received Marketing Authorisation on 21 March 2007, and Tesavel on 11 January 2008.
Efficacy findings include a placebo-adjusted difference in A1C reduction at Week 20 of -0.19%. The P-value for this A1C reduction was 0.448. In a study, the reduction from baseline in A1C at Week 20 was -0.90% for Sita/Met IR FDC and -0.33% for Metformin IR. For Sita/Met XR FDC, the reduction from baseline in A1C at Week 20 was -0.19%, compared to -0.54% for Metformin XR. HbA1c reduction from baseline was observed.
Safety considerations include an age restriction for individuals below 18 years. In study P351, there was 1 reported death and 3 participants with pregnancies. Study P351 had a duration of 5 years, while study P083 had a duration of 54 weeks. The mean A1C at baseline in MK-0431-083 was 7.5%.
Key figures — cited to the source page
| Change from baseline in A1C at Week 20 (placebo-adjusted difference) | -0.19 | Merck & Co., Inc. — Ristaben EMA EPAR variation assessment r, p.5 |
| P-value for A1C reduction at Week 20 (placebo-adjusted difference) | 0.448 | Merck & Co., Inc. — Ristaben EMA EPAR variation assessment r, p.5 |
| Reduction from baseline in A1C at Week 20 (Sita/Met IR FDC) | -0.90 | Merck & Co., Inc. — Ristaben EMA EPAR variation assessment r, p.5 |
| Reduction from baseline in A1C at Week 20 (Metformin IR) | -0.33 | Merck & Co., Inc. — Ristaben EMA EPAR variation assessment r, p.5 |
| Age restriction | below 18 years | Merck & Co., Inc. — Ristaben EMA EPAR public assessment repo, p.5 |
| Number of participant deaths in P351 | 1 | Merck & Co., Inc. — Ristaben EMA EPAR variation assessment r, p.12 |
| Number of participants with pregnancies in P351 | 3 | Merck & Co., Inc. — Ristaben EMA EPAR variation assessment r, p.13 |
| CHMP positive opinion date for Ristaben | 17 December 2009 | Merck & Co., Inc. — Ristaben EMA EPAR public assessment repo, p.4 |
Source documents
Explore the full evidence
All 75 cited findings for Ristaben — 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.