Diabetes Care published online the results of the Novo Nordisk (NVO) LEAD™ 6 extension study, which evaluated the efficacy and safety of switching from exenatide, which is taken twice a day, to once-daily Victoza®. Results show that when added to oral antidiabetes drugs (OADs), patients who switched from exenatide to Victoza experienced further reductions in A1c and weight loss.
LEAD™ 6 was a 26-week randomized, open-label study in type 2 diabetes comparing the efficacy and safety of Victoza 1.8 milligrams, once a day + OAD, to exenatide 10 micrograms, twice a day + OAD. In the 14-week extension, patients were switched from exenatide 10 micrograms to Victoza. Exenatide patients were switched to Victoza by titrating the Victoza dose in 0.6 milligram increments weekly to reach the target dose of 1.8 milligrams per day. Patients randomized to Victoza in the initial phase of the study continued on the 1.8 milligram dose.
"Because Victoza and exenatide are the only GLP-1 agonists currently available, we were very interested to see if there were clinically meaningful differences in the effect of switching from exenatide to Victoza in people with type 2 diabetes," said Dr. John Buse, chief of endocrinology and director of the Diabetes Care Center at the University of North Carolina School of Medicine, and one of the principal investigators in the study. "Clinical benefits were seen in patients who switched from exenatide to Victoza. The significant improvements in blood sugar lowering and fasting glucose confirm the original findings of the trial regarding the efficacy of Victoza."
For patients switched to the Victoza 1.8 milligram group, mean A1C decreased from 7.2% at week 26 to 6.9% at week 40 (-0.32 +/-0.043%). A greater percentage of patients reached their A1C targets after switching from exenatide to Victoza (42.5% vs 57.9%). Switched patients also experienced further reductions in fasting plasma glucose (FPG) (0.9 +/-0.16 mmol/L), bodyweight (-1.98 +/-0.33 lbs), and systolic blood pressure (SBP) (-3.8 +/-0.84 mmHg). In those continuing Victoza, reductions in FPG (-0.2 +/-0.11 mmol/L), bodyweight (-0.88 +/-0.33 lbs) and SBP (-2.2 +/-0.88 mmHg) occurred.
Similar numbers of patients reported adverse events in the extension. The most common adverse events reported were diarrhea and nausea.
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