MedWire News: Results from the GALIANT trial confirm that vildagliptin is as effective as rosiglitazone or pioglitazone at improving glycemic control in Type 2 diabetes patients when added to metformin therapy.
“Vildagliptin, a novel, orally active, potent and selective inhibitor of dipeptidyl peptidase 4, represents a new option for the control of Type 2 diabetes,” say Lawrence Blonde (Ochsner Medical Center, New Orleans, Los Angeles, USA) and colleagues.
Previous studies, as reported by MedWire News, have demonstrated that vildagliptin improves islet function and reduces glycated hemoglobin (HbA1c) both as a monotherapy and in combination with metformin.
In the GALIANT (GALvus In Addition to metformin versus? Tzd/metformin in lowering HbA1c) study, Blonde and team randomly assigned 1653 patients to vildagliptin 100 mg/day or a thiazolidinedione (either pioglitazone or rosiglitazone at a dose at the investigators discretion) for a period of 3 months.
All participants had inadequately controlled Type 2 diabetes and were taking a stable dose of metformin greater than or equal to 1000 mg/day at baseline, which they continued throughout the study.
The researchers found that the average reduction in HbA1c from baseline to study completion was 0.68% and 0.57% in the vildagliptin and thiazolidinedione groups, respectively, establishing non-inferiority of vildagliptin to thiazolidinediones for glycemic control.
Of note, vildagliptin add-on therapy had a more favorable effect on body weight than thiazolidinediones with an average reduction of 0.58 kg at 3 months compared with a mean gain of 0.33 kg in the patients treated with add-on pioglitazone or rosiglitazone.
Adverse events were mostly minor and the overall frequency did not differ significantly between groups at 39.5% for vildagliptin versus 36.3% for thiazolidinediones.
“This study suggests that data previously reported from longer controlled phase III studies translates to settings emulating routine primary care practice in the USA, with vildagliptin having a similar efficacy to thiazolidinediones as an add-on to metformin,” conclude the authors in the journal Diabetes, Obesity and Metabolism.
They add: “Longer term studies in a primary care setting would be valuable.”
MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009
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