PRINCETON, N.J., Sept. 25 Data from a 52-week phase 3 study (LEADTM 3) of Novo Nordisk's (NYSE: NVO) liraglutide, a once-daily human GLP-1 analog, were published online today in The Lancet. The study showed that liraglutide, when taken alone, produces statistically significant and sustained improvements in blood sugar control in patients with early type 2 diabetes, as compared with glimepiride, a widely used oral anti-diabetic drug. Moreover, the treatment with liraglutide led to weight loss, reduced systolic blood pressure and lowered rates of hypoglycemia after 52 weeks of treatment.
"Publication of this data in The Lancet means that more physicians will have access to these key results on liraglutide's efficacy as monotherapy in the treatment of type 2 diabetes," said principal study investigator Alan Garber, MD, Professor of Medicine, Biochemistry & Molecular Biology, and Molecular & Cellular Biology Division of Diabetes, Endocrinology & Metabolism, Baylor College of Medicine, Texas. "In addition to effective glycemic control for at least one year, liraglutide treatment also led to a number of other clinical benefits when given to patients early on in the course of their disease."
Type 2 diabetes is a progressive disease. Many treatments are effective early on in the course of the disease but do not maintain their effectiveness. After 52 weeks of treatment, 62% of treatment-naive patients treated with liraglutide 1.8 mg achieved an average reduction in blood sugar below the American Diabetes Association target for HbA1c of less than 7% and maintained this reduction over the 52-week study period.
In addition, patients treated with liraglutide had significant weight loss. A mean weight loss of 2.05+/-4.40 kg and 2.45+/-4.37 kg occurred with liraglutide 1.2 mg and 1.8 mg, respectively, versus a weight gain of 1.12+/-4.24 kg with glimepiride.
There were no major hypoglycemic episodes reported during the study. The rate of minor hypoglycemia was statistically significantly lower in both liraglutide dose groups compared with the glimepiride-treated group. The most common gastrointestinal-related adverse events with liraglutide were nausea, diarrhea and vomiting, and most were transient. Other adverse events reported included flu-like symptoms.
Liraglutide is a once-daily human analog of the naturally occurring hormone Glucagon-Like Peptide-1 (GLP-1). Liraglutide works by stimulating the release of insulin only when blood sugar levels become too high and by inhibiting appetite. On May 23, 2008, Novo Nordisk submitted a New Drug Application to the Food and Drug Administration in the United States as well as a marketing authorization application to the European Medicines Agency in Europe for the approval of liraglutide for the treatment of patients with type 2 diabetes. A New Drug Application was also submitted for approval in Japan on July 14, 2008.
About LEAD(TM) (Liraglutide Effect and Action in Diabetes)
The LEAD(TM) 3a program involved about 4000 patients with type 2 diabetes in 40 countries.
The data published early online and in an upcoming edition of The Lancet is from the LEAD(TM) 3 study, one of five randomized, controlled, double-blinded studies that make up the phase 3a program for liraglutide.
Data from the LEAD(TM) 3 study have previously been reported on by Novo Nordisk in a Stock Exchange Announcement on December 11, 2007, and in a press release on June 9, 2008, in connection with the American Diabetes Association meeting in San Francisco.
Novo Nordisk is a healthcare company with an 85-year history of innovation and achievement in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insuli