e 3 Mean HbA1c for patients who completed the 52-week trial and for the Last Observation Carried Forward (LOCF, intent-to-treat) data at Week 52 (Monotherapy)
14.2 Combination TherapyAdd-on to MetforminIn this 26-week trial, 1091 patients were randomized to Victoza 0.6 mg, Victoza 1.2 mg, Victoza 1.8 mg, placebo, or glimepiride 4 mg (one-half of the maximal approved dose in the United States), all as add-on to metformin. Randomization occurred after a 6-week run-in period consisting of a 3-week initial forced metformin titration period followed by a maintenance period of another 3 weeks. During the titration period, doses of metformin were increased up to 2000 mg/day.
Treatment with Victoza 1.2 mg and 1.8 mg as add-on to metformin resulted in a significant mean HbA1c reduction relative to placebo add-on to metformin and resulted in a similar mean HbA1c reduction relative to glimepiride 4 mg add-on to metformin (Table 5). The percentage of patients who discontinued due to ineffective therapy was 5.4% in the Victoza 1.8 mg + metformin treatment group, 3.3% in the Victoza 1.2 mg + metformin treatment group, 23.8% in the placebo + metformin treatment group, and 3.7% in the glimepiride + metformin treated group.
Table 5 Results of a 26-week trial of Victoza as add-on to metformina
Victoza
1.8 mg
+Metformin |
Victoza
1.2 mg
+Metformin |
Placebo
+Metformin |
Glimepiride 4 mg†
+Metformin |
|
Intent-to-Treat Population (N) |
242 |
240 |
121 |
242 |
|
HbA1c (%) (Mean) |
|
|
|
|
|
Baseline |
8.4 |
8.3 |
8.4 |
8.4 |
|
Change from baseline (adjusted mean) b |
-1.0 |
-1.0 |
+0.1 |
-1.0 |
|
Difference from placebo + metformin arm (adjusted mean) b |
-1.1** |
-1.1** |
|
|
|
95% Confidence Interval |
(-1.3, -0.9) |
(-1.3, -0.9) |
|
|
|
Patients (%) achieving A1C ≤7% |
42 |
35 |
11 |
36 |
|
Fasting Plasma Glucose (mg/dL) (Mean) |
|
|
|
|
|
Baseline |
181 |
179 |
182 |
180 |
|
Change from baseline (adjusted mean) b |
-30 |
-30 |
+7 |
-24 |
|
Difference from placebo + metformin arm (adjusted mean) b |
-38** |
-37** |
|
|
|
95% Confidence Interval |
(-48, -27) |
(-47, -26) |
|
|
|
Difference from glimepiride + metformin arm (adjusted mean) b |
-7 |
-6 |
|
|
|
95% Confidence Interval |
(-16, 2) |
(-15, 3) |
|
|
|
Body Weight (kg) (Mean) |
|
|
|
|
|
Baseline |
88.0 |
|
|
