US approves New drugs
These include Nesina (alogliptin), Kazano (alogliptin and metformin hydrochloride), and Oseni (alogliptin and pioglitazone) tablets.
Nesina was demonstrated to be safe and effective in 14 clinical trials involving about 8500 patients with type 2 diabetes (with average reductions in HbA1c levels of 0.4–0.6%, compared with placebo after 26 weeks).
Kazano has been tested in four clinical trials with more than 2500 patients, resulting in additional reductions in HbA1c of 1.1% over Nesina, and 0.5% over metformin after 26 weeks. Additionally, Oseni has shown reductions in HbA1c of 0.4–0.6% over pioglitazone alone , and 0.4% to 0.9% over alogliptin alone.
The FDA is requiring post-marketing studies and pharmaco-vigilance programs for these new drugs.