Novo Nordisk reported headline results Monday showing that a late-stage study of liraglutide in obese or overweight people with type 2 diabetes met all three main goals. "We are pleased about the outcome of this trial," remarked chief science officer Mads Krogsgaard. The company said it expects to complete the two remaining Phase IIIa trials in its SCALE programme for the drug by mid-2013.
The SCALE Diabetes study randomised 846 overweight or obese patients to receive liraglutide 3 milligrams, liraglutide 1.8 milligrams or placebo for 56 weeks, followed by a 12-week observation period. Results demonstrated that patients given the higher dose of liraglutide had weight loss of 6 percent and those given the lower dose had weight loss of 5 percent, with both figures being significantly higher than the 2 percent recorded for placebo. Further, 50 percent of patients in the liraglutide 3 milligram group, 35 percent of patients in the liraglutide 1.8 milligram arm and 13 percent of patients in the placebo group lost at least 5 percent of their body weight during the trial.
Commenting on the data, Alm Brand analyst Michael Friis Jorgensen noted that "5 and 6 percent is on the low side in efficacy, but it is important to note that it is enough to be approved by the FDA." Sydbank analyst Soren Lontoft Hansen called the results "robust," but an unnamed analyst said the data were "so so," adding that the fact there was just a marginal benefit from using the highest dose was a particular concern.
Further results of the study showed that 69 percent of patients in the liraglutide 3 milligram group and 67 percent of patients in the liraglutide 1.8 milligram arm achieved the HbA1c treatment target of 7 percent, versus 27 percent of patients in the placebo group. "This SCALE trial shows that it is possible to achieve both clinically significant weight loss and excellent glucose control with a single treatment in patients with type 2 diabetes," Krogsgaard added.
For related analysis, read ViewPoints: Reality bites for Novo Nordisk – obesity data does little to curb share price decline.
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