Strong data on Merck & Co's Janumet

US drug major Merck & Co presented data at the 19th world congress of the International Diabetes Federation, held in Cape Town, South Africa, showing a significant placebo-subtracted mean HbA1c reduction of 2.1% (p<0.001) for patients on 100mg/day of Januvia (sitagliptin) plus 2g/day metformin, as initial therapy. The investigational combination, named Janumet, also yielded substantial mean placebo-subtracted reductions of post-prandial, glucose levels and fasting plasma glucose levels.

Also at the IDF congress, Merck presented results from an open-label, 117-patient cohort from this study, demonstrating that initial co-administration of the two drugs in patients with severely elevated baseline HbA1c showed a significant mean reduction from baseline of 2.9%. In the primary analysis of the study, approximately twice as many patients achieved the IDF's recommended HbA1c goal level of less than 6.5% with initial co-administration of sitagliptin 100mg plus metformin 2,000mg (43.8%) versus metformin alone (20.3%; p<0.001).

In a separate, 52-week, non-inferiority study that evaluated the combination of sitagliptin plus metformin and glipizide plus metformin, a significant difference in body weight of 2.5kg (p<0.001) was observed between groups with modest weight loss among patients receiving sitagliptin. Peter Stein, senior director of clinical research at Merck, said that the "data presented today support our decision to file for approval of sitagliptin/metformin HCl, a new product that combines sitagliptin with metformin as one agent for patients with type 2 diabetes."