Galvus Combination Lowers HbA1c By Up To 2.8%
13 Jun 2006
Galvus combined with pioglitazone reduces HbA1c by up to 2.8% in type two diabetes patients, say Galvus makers, Novartis. Compared with pioglitazone alone, with the Galvus combination there is no significant weight gain and less edema.
Galvus, a member of the DPP-4 inhibitor class, is awaiting FDA approval as a once daily oral treatment for type two diabetes patients. Phase III studies have shown it to be especially effective in lowering blood sugar levels in patients with poor glycemic control. Obese patients also benefit by losing weight.
Novartis presented its findings at the 66th Scientific Sessions of the American Diabetes (ADA) meeting, Washington DC.
Galvus combined with pioglitazone resulted in an average A1c 1.9% reduction. 65% of patients on the Galvus and pioglitazone combination achieved the ADA-defined A1c target of 7% or less. This compared to just 42.5% of patients who were given just Galvus, and 42.9% who were given just pioglitazone. Patients with poor glycemic control experienced reductions of up to 2.8% in A1c. Patients with poor glycemic control had baseline blood sugar levels of about 10% before treatment started.
Patients over 65% who received the combination of Galvus and pioglitazone experienced a 2.3% drop in A1c from a baseline of 8.4%. Patients with a BMI of equal or more than 35 and had an A1c baseline of 8.6% dropped by 2.2%.
Obese patients taking the Galvus combination treatment also lost weight.
James Shannon, MD, Head of Development at Novartis Pharma AG, said "These new data underscore the significant efficacy and good tolerability that have been consistently observed in the robust Galvus clinical development program. The magnitude of A1c reductions seen in the combination of Galvus and a TZD is encouraging for patients struggling to reach and maintain their blood sugar levels. The trial results for Galvus continue to reinforce the benefits of treating both islet dysfunction and insulin resistance in type 2 diabetes."
Regulatory filings in the European Union for Galvus are expected to be completed later on this year. Galvus was accepted for US regulatory review earlier on this year.
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Written by: Christian Nordqvist
Editor: Medical News Today
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