Novartis' 24-week, double-blind, randomized, multi-center, parallel-group, placebo-controlled trial evaluating Galvus (vildagliptin) has demonstrated safety profile generally equals to placebo in type 2 diabetes and moderate or severe renal impairment patients, when added to an anti-diabetic therapy.
The study also demonstrated that vildagliptin added to current therapy resulted in significant improvements in glycemic control.
The data showed that the overall safety and tolerability of vildagliptin 50 mg in patients with moderate or severe renal impairment were generally similar to placebo.
The study involved around 294 patients with moderate renal impairment and 221 with severe renal impairment and both groups were randomized to receive vildagliptin or placebo
Novartis Pharma Cardiovascular and Metabolism Development Franchise global head Ameet Nathwani said safety is the primary concern in the treatment of patients with renal impairment and this study demonstrated strong safety results with vildagliptin, without compromising on efficacy.