Among the interesting studies announced at the American Diabetes Association (ADA) Scientific Sessions 2010 was a head-to-head comparison of two new incretin-based drugs for type 2 diabetics.  The full, one-year data presented at the meeting showed that Novo Nordisk’s GLP-1 analog Victoza outperformed Merck & Co’s DPP-4 inhibitor Januvia.  These findings were consistent with the 26-week results of this trial which were featured earlier this year in The Lancet. Given these promising results, I was pleased to be able to...

Late-breaking Novo Nordisk extension data presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) showed that once-daily Victoza in combination with metformin produced sustained and significantly greater reductions in A1c, body weight and fasting plasma glucose (FPG) than Januvia plus metformin at 52 weeks. The study found that patients treated with 1.2 mg and 1.8 mg of Victoza experienced greater reductions in A1c than those treated with Januvia 100 mg (-1.3% and -1.5% versus -0.9%). Victoza...

Novo Nordisk today announced the decision to re-initiate the global phase 3 development program of liraglutide for the treatment of obesity. Following the US approval of Victoza for the treatment of type 2 diabetes, Novo Nordisk has been in dialogue with the FDA regarding the further progression of the development program investigating the potential of liraglutide within obesity. Based on the feedback from the FDA, Novo Nordisk now plans to re-initiate the global phase 3 program in the first half of 2011 in clinical trials comprising...

Novo Nordisk announced that it has received approval for the price of Victoza, a once-daily human GLP-1 analogue for the treatment of type 2 diabetes, from Japan’s Central Social Insurance Medical Council (Chuikyo), the advisory committee to the Minister of Health, Labour and Welfare. The price approval allows Novo Nordisk to commercially launch in Japan shortly after Victoza is officially posted on Japan’s National Health Insurance price list on June 11th. Victoza was approved by the Minister of Health, Labour and Welfare...

Novo Nordisk (NVO) announced today details of the company’s cardiovascular outcomes trial for Victoza® (liraglutide [rDNA origin] injection), which is set to start in the autumn of 2010. The trial named LEADER™ (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) aims to assess and confirm the cardiovascular safety of the company’s new once-daily human GLP-1 analog Victoza®.  The trial satisfies the new FDA guideline for type 2 diabetes treatments. The protocol of this trial...

Novo Nordisk’s new diabetes drug Victoza proved more effective than Merck & Co’s Januvia in a head-to-head study published, in the Lancet. The 26-week trial showed that Victoza produced significantly greater reductions in HbA1C, fasting plasma glucose and body weight than Januvia, with similar or better overall treatment satisfaction. According to a Novo Nordisk announcement significantly more patients achieved the HbA1c targets of <7·0% (American Diabetes Association [ADA]). Nearly twice as many study...

According to a Novo Nordisk announcement the results from their LEAD™ 6 extension study show that switching to once-daily Victoza® (Liraglutide [rDNA Origin] Injection) from exenatide improves blood sugar control in patients with type 2 diabetes. The study published online in Diabetes Care evaluated the efficacy and safety of switching from exenatide, which is taken twice a day, to once-daily Victoza®. The results showed that patients who switched to the Victoza had improved A1C levels, a further reduction in fasting plasma glucose,...

According to Novo Nordisk’s 2009 financial statements, the company’s operating profit has increased by 25% in 2009, a trend they expect will continue through 2010. One of the primary contributors to this increase is the growth in its sale of insulin products. The sale of insulin increased by 24% in the past year. Another important product that the company expects will contribute to its continuing growth is Victoza®, the once-daily human GLP-1 analogue for the treatment of type 2 diabetes, which was approved  both by...

Novo Nordisk announced that it has received US FDA approval for Victoza® (liraglutide) for the treatment of type 2 diabete in adults. Victoza® is the brand name approved in the US and Europe for liraglutide, the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes. In the US, Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Novo Nordisk expects to introduce Victoza® in the US market within weeks.

Novo Nordisk today announced that formal feedback from the United States Food and Drug Administration (FDA) regarding liraglutide is expected within weeks. Liraglutide is the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes. Liraglutide works by stimulating the release of insulin only when glucose levels become too high, and by inhibiting appetite. In Europe, Novo Nordisk received marketing authorization for liraglutide under the brand name Victoza® on 30 June 2009.