Difference from placebo + metformin arm (adjusted mean) b -1.3* -1.1*    
95% Confidence Interval (-2.2, -0.4) (-2.0, -0.2)    
Difference from glimepiride + metformin arm (adjusted mean) b -3.8** -3.5**  
95% Confidence Interval (-4.5, -3.0) (-4.3, -2.8)    
aIntent-to-treat population using last observation on study
bLeast squares mean adjusted for baseline value
†For glimepiride, one-half of the maximal approved United States dose.
*-value <0.05
**p-value <0.0001
Add-on to Sulfonylurea
In this 26-week trial, 1041 patients were randomized to Victoza 0.6 mg, Victoza 1.2 mg, Victoza 1.8 mg, placebo, or rosiglitazone 4 mg (one-half of the maximal approved dose in the United States), all as add-on to glimepiride. Randomization occurred after a 4-week run-in period consisting of an initial, 2-week, forced-glimepiride titration period followed by a maintenance period of another 2 weeks. During the titration period, doses of glimepiride were increased to 4 mg/day. The doses of glimepiride could be reduced (at the discretion of the investigator) from 4 mg/day to 3 mg/day or 2 mg/day (minimum) after randomization, in the event of unacceptable hypoglycemia or other adverse events.

Treatment with Victoza 1.2 mg and 1.8 mg as add-on to glimepiride resulted in a statistically significant reduction in mean HbA1c compared to placebo add-on to glimepiride (Table 6). The percentage of patients who discontinued due to ineffective therapy was 3.0% in the Victoza 1.8 mg + glimepiride treatment group, 3.5% in the Victoza 1.2 mg + glimepiride treatment group, 17.5% in the placebo + glimepiride treatment group, and 6.9% in the rosiglitazone + glimepiride treatment group.

Table 6 Results of a 26 Week Trial of Victoza in combination with sulfonylureaa