he 2 trials where ethnicity was captured, 27% of patients were Hispanic/Latino and 73% were Non-Hispanic/Latino. In each of these trials, treatment with Victoza produced clinically and statistically significant improvements in hemoglobin A1c and fasting plasma glucose (FPG) compared to placebo. Victoza did not have adverse effects on blood pressure.
All Victoza-treated patients started at 0.6 mg/day. The dose was increased in weekly intervals by 0.6 mg to reach 1.2 mg or 1.8 mg for patients randomized to these higher doses. Victoza 0.6 mg is not effective for glycemic control and is intended only as a starting dose to reduce gastrointestinal intolerance [see Dosage and Administration (2)].
14.1MonotherapyIn this 52-week trial, 746 patients were randomized to Victoza 1.2 mg, Victoza 1.8 mg, or glimepiride 8 mg. Patients who were randomized to glimepiride were initially treated with 2 mg daily for two weeks, increasing to 4 mg daily for another two weeks, and finally increasing to 8 mg daily. Treatment with Victoza 1.8 mg and 1.2 mg resulted in a statistically significant reduction in HbA1c compared to glimepiride (Table 4). The percentage of patients who discontinued due to ineffective therapy was 3.6% in the Victoza 1.8 mg treatment group, 6.0% in the Victoza 1.2 mg treatment group, and 10.1% in the glimepiride-treatment group.
Table 4 Results of a 52-week monotherapy triala
Victoza
1.8 mg |
Victoza
1.2 mg |
Glimepiride
8 mg |
|
Intent-to-Treat Population (N) |
246 |
251 |
248 |
|
HbA1c (%) (Mean) |
|
|
|
|
Baseline |
8.2 |
8.2 |
8.2 |
|
Change from baseline (adjusted mean) b |
-1.1 |
-0.8 |
-0.5 |
|
Difference from glimepiride arm (adjusted mean) b |
-0.6** |
-0.3* |
|
|
95% Confidence Interval |
(-0.8, -0.4) |
(-0.5, -0.1) |
|
|
Patients (%) achieving A1c <7% |
51 |
43 |
28 |
|
Fasting Plasma Glucose (mg/dL) (Mean) |
|
|
|
|
Baseline |
172 |
168 |
172 |
|
Change from baseline (adjusted mean) b |
-26 |
-15 |
-5 |
|
Difference from glimepiride arm (adjusted mean) b |
-20** |
-10* |
|
|
95% Confidence Interval |
(-29, -12) |
(-19, -1) |
|
|
Body Weight (kg) (Mean) |
|
|
|
|
Baseline |
92.6 |
92.1 |
93.3 |
|
Change from baseline (adjusted mean) b |
-2.5 |
-2.1 |
+1.1 |
|
Difference from glimepiride arm (adjusted mean) b |
-3.6** |
-3.2** |
|
|
95% Confidence Interval |
(-4.3, -2.9) |
(-3.9, -2.5) |
aIntent-to-treat population using last observation on study
bLeast squares mean adjusted for baseline value
*-value <0.05
**p-value <0.0001
Figur |
