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Galvus® Demonstrates Powerful Blood Sugar Reductions In Phase III Studies

Posted: Thursday, September 21, 2006

Galvus dropped A1c by 1.8% without weight gain.

Galvus® (vildagliptin), submitted for US and EU approval as a once-daily oral treatment for type 2 diabetes, has demonstrated impressive efficacy and an attractive tolerability profile.

These findings from Phase III studies were presented at the 42nd European Association for the Study of Diabetes (EASD) meeting in Copenhagen, Denmark.

Galvus showed equivalent efficacy to the diabetes medicine rosiglitazone, an insulin sensitizer known as a thiazolidinedione (or TZD), in a head-to-head monotherapy study that led to an overall 1.8% reduction in blood sugar levels as measured by HbA1c (A1c). The results were achieved without weight gain overall and with a lower incidence of edema (fluid retention) - both of which are side effects commonly associated with TZDs[1].

Professor Emanuele Bosi, Director of the Diabetes & Endocrinology Unit at San Raffaele University Hospital in Milan, Italy, stated that "Vildagliptin has been tested in combination with many currently available drugs, resulting in effective A1c reductions with an excellent side-effect profile.

Galvus, a member of the DPP-4 inhibitor class, works through a novel mechanism of action targeting the pancreatic islet dysfunction that causes high blood sugar levels in people with type 2 diabetes. Islet dysfunction can specifically lead to excess sugar production (via glucagon from the alpha-cells) and reduced insulin production (from the beta-cells). Galvus affects both pancreatic alpha- and beta-cells, improving their ability to appropriately sense and respond to sugar in the blood.

The European marketing application for Galvus was filed in August 2006, while the US submission was completed in March 2006. The submissions included data from clinical trials involving more than 5,400 patients worldwide.

The four highlighted trials at EASD were part of a broad overview of clinical data summarizing the development as well as overall efficacy and tolerability of Galvus. A total of 17 clinical and preclinical Galvus investigations were part of the congress scientific program.

The head-to-head monotherapy comparison of Galvus (100 mg daily) and rosiglitazone (8 mg daily) involved 697 patients in a six-month study. Galvus reduced blood sugar levels significantly as measured by A1c and was comparable to the TZD, particularly in high baseline patients (-1.8%). Galvus treatment was not associated with weight gain overall, while people in the rosiglitazone group gained on average 1.6 kg. Galvus-treated patients also experienced a lower incidence of edema (2.5% vs. 4.9%)[1]. (EASD abstract #0789)

In another study presented at EASD, a treatment combination of Galvus and the TZD pioglitazone resulted in 65% of patients on Galvus achieving the American Diabetes Association (ADA)-defined A1c blood sugar goal of less than 7% compared to 42% of those who achieved this goal on monotherapy treatment (Galvus 42.5% or pioglitazone 42.9%). Side effects were consistent with the individual tolerability profiles of Galvus and TZDs, while the combination was also well tolerated[5]. (EASD abstract #0801)

A new dose-ranging study presented at EASD concluded that Galvus taken once-daily was effective in lowering A1c levels. The trial of 279 patients who had not been treated previously with diabetes medicines found similar, significant A1c reductions among patients taking Galvus 100 mg daily, regardless of whether this was given as a once-daily dose or as 50 mg twice-daily[6]. (EASD abstract #0791)

Another presentation showed positive results of a 24-week trial when Galvus was combined with metformin, another commonly prescribed diabetes medicine. The results showed a 1.1% reduction in blood sugar level as measured by A1c when compared to metformin alone[7]. Galvus was also very well tolerated in this study[7]. (EASD abstract #0793)

Throughout the clinical development program, Galvus has shown no weight gain overall. In one study, obese patients treated with Galvus demonstrated a relative weight benefit of 2.8 kg compared to those taking TZDs[3]. This is potentially important since many people with type 2 diabetes often struggle to keep their weight under control.

Galvus has also demonstrated a good tolerability profile with a very low incidence of hypoglycemia (excessively low blood sugar) and edema (fluid retention) in monotherapy trials. The most commonly seen side effects in clinical studies with Galvus include cold/flu like symptoms, headache and dizziness[3].

Source: Diabetes In Control: Presented at the European Association for the Study of Diabetes 2006 Meeting.