Januvia study shows hypoglycaemia benefit

pharmafile | June 13, 2008 | News story | Sales and Marketing  

A new study of Merck Sharp & Dohme's Januvia showed it lowered the risk of hypoglycaemia, compared to an older diabetes drug.

The trial compared Januvia (sitagliptin), an oral, once-daily, selective dipeptidyl peptidase-4 (DPP-4) inhibitor, with the sulfonylurea glipizide.

Januvia showed a 93% lower risk of having a confirmed symptomatic hypoglycemic event – a common side effect of some oral diabetes medications – compared to treatment with glipizide,

In the 52-week trial, Januvia and glipizide were added to ongoing metformin therapy in patients with type 2 diabetes. Januvia is already indicated, as an adjunct to diet and exercise, to improve glycaemic control in adult patients.

The risk of hypoglycemia was 97% lower in patients over 65 and 91% lower in the under-65s with Januvia compared to glipizide.

DPP-4 inhibitors work by increasing the active levels of incretin hormones to enhance patients own ability to control blood sugar levels. It does this by triggering the pancreas to increase the release of insulin and signal the liver to reduce its production of glucose, thus helping to lower blood sugar levels.

Since DPP-4 inhibitors are proven to be as effective as existing treatments at lowering blood sugar levels, but have fewer side-effects, such as weight gain, the drugs are expected to be attractive to doctors, threatening other oral diabetes treatments such as GSK's Avandia (rosiglitazone).

Analysts have predicted global peak sales in excess of $1.5 billion for Januvia and Novartis' DPP-4 rival Galvus (vildagliptin).

Meanwhile Onglyza (saxagliptin), an investigational DPP-4 inhibitor being developed by Bristol-Myers Squibb and AstraZeneca, has also recently shown positive study results.

It was found to produce significant reductions in key measures of glucose control (glycosylated hemoglobin level, fasting plasma glucose and postprandial glucose when treating patients with type 2 diabetes compared to placebo.

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