Starlix nateglinide: Phase I/II data; Phase III

In a crossover study of 10 Type II diabetics who received 30, 60 or 120 mg of Starlix or placebo before meals, Starlix produced rapid and short-lived insulin release and blunted mealtime glucose bursts. Increases in insulin and decreases in glucose were seen with each dose over multiple time points (p<0.05 versus placebo), and the 60 and 120 mg doses were found to be equally effective. The compound was well-tolerated, with no hypoglycemia reported.

In a separate study comparing Starlix to Novo Nordisk's Prandin repaglinide in 14 healthy subjects, Starlix showed a more rapid and shorter duration of action, a plus since it normalizes glucose quickly after meals without long-term insulin exposure. Patients received 0.5 or 2 mg of Prandin or 120 mg Starlix before meals. While both reduced glucose and increased insulin, glucose levels returned to predose levels within 4 hours of Starlix treatment versus 8 hours with Prandin. ...