Janumet XR approved for type 2 diabetes
Merck announced that the FDA has approved Janumet XR (sitagliptin/metformin HCl extended-release tablets) for the treatment of type 2 diabetes. Janumet XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both sitagliptin and extended-release metformin is appropriate.
This approval was based on a randomized, double-blind, placebo-controlled factorial bioequivalence study that demonstrated that administration of Janumet XR was equivalent to co-administration of corresponding doses of the two individual medications, sitagliptin and metformin HCl extended- release.
In the study, which was conducted in 1,091 patients with type 2 diabetes who had inadequate glycemic control on diet and exercise, co-administrating metformin immediate-release 2000 mg and sitagliptin 100mg daily resulted in a mean 2.1% reduction of A1C relative to placebo at 24 weeks from a mean baseline A1C of 8.8% (P<0.001).
The mean placebo-adjusted A1C reductions in the other arms of the study were 1.6% with sitagliptin 100 mg daily and metformin immediate-release 1000 mg daily; 1.3% with metformin immediate-release 2000mg daily; 1% with metformin immediate-release 1000 mg daily; and 0.8% with sitagliptin, (P<0.001 for all treatment groups vs. placebo).
At 24 weeks, 66% of patients treated with the initial combination of sitagliptin 100 mg daily and metformin immediate-release 2000 mg daily achieved the American Diabetes Association (ADA) goal A1C level of less than 7%, compared to 38% of patients treated with metformin immediate-release 2000 mg daily alone.
In the other arms of the study, 43% of patients treated with sitagliptin 100 mg daily and metformin immediate-release 1000 mg daily, 23% of patients treated with metformin immediate-release 1000 mg daily, and 20% of patients treated with sitagliptin achieved the ADA goal A1C level of <7%.
Janumet XR is expected to be available in the coming weeks in 50 mg/500 mg, 50 mg/1000 mg, 100 mg/1000 mg fixed combination strength tablets.
For more information, call (800) 672-6372 or visit www.merck.com.