|
Change from baseline (adjusted mean) b |
-1.3 |
-0.2 |
-1.1 |
|
Difference from placebo + metformin + glimepiride arm (adjusted mean) b |
-1.1** |
|
|
|
95% Confidence Interval |
(-1.3, -0.9) |
|
|
|
Patients (%) achieving A1c <7% |
53 |
15 |
46 |
|
Fasting Plasma Glucose (mg/dL) (Mean) |
|
|
|
|
Baseline |
165 |
170 |
164 |
|
Change from baseline (adjusted mean) b |
-28 |
+10 |
-32 |
|
Difference from placebo + metformin + glimepiride arm (adjusted mean) b |
-38** |
|
|
|
95% Confidence Interval |
(-46,- 30) |
|
|
|
Body Weight (kg) (Mean) |
|
|
|
|
Baseline |
85.8 |
85.4 |
85.2 |
|
Change from baseline (adjusted mean) b |
-1.8 |
-0.4 |
1.6 |
|
Difference from placebo + metformin + glimepiride arm (adjusted mean) b |
-1.4* |
|
|
|
95% Confidence Interval |
(-2.1, -0.7) |
|
aIntent-to-treat population using last observation on study
bLeast squares mean adjusted for baseline value
†For insulin glargine, optimal titration regimen was not achieved for 80% of patients.
*p-value <0.05
**p-value <0.0001
Add-on to Metformin and Thiazolidinedione
In this 26-week trial, 533 patients were randomized to Victoza 1.2 mg, Victoza 1.8 mg or placebo, all as add-on to rosiglitazone (8 mg) plus metformin (2000 mg). Patients underwent a 9 week run-in period (3- week forced dose escalation followed by a 6-week d
ose maintenance phase) with rosiglitazone (starting at 4 mg and increasing to 8 mg/day within 2 weeks) and metformin (starting at 500 mg with increasing weekly increments of 500 mg to a final dose of 2000 mg/day). Only patients who tolerated the final dose of rosiglitazone (8 mg/day) and metformin (2000 mg/day) and completed the 6-week dose maintenance phase were eligible for randomization into the trial.
Treatment with Victoza as add-on to metformin and rosiglitazone produced a statistically significant reduction in mean HbA1c compared to placebo add-on to metformin and rosiglitazone (Table 8). The percentage of patients who discontinued due to ineffective therapy was 1.7% in the Victoza 1.8 mg + metformin + rosiglitazone treatment group, 1.7% in the Victoza 1.2 mg + metformin + rosiglitazone treatment group, and 16.4% in the placebo + metformin + rosiglitazone treatment group.
Table 8 Results of a 26-week trial of Victoza as add-on to metformin and thiazolidinedionea
Victoza
1.8 mg +
Metformin +
Rosiglitazone |
Victoza
1.2 mg +
Metformin +
Rosiglitazone |
Placebo+
Metformin+ Rosiglitazone |
|
Intent-to-Treat Population (N) |
178 |
177 |
