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 insulin delivery systems. In addition to
diabetes care, Novo Nordisk has a leading position within areas such as
hemostasis management, growth hormone therapy, and hormone therapy for
women. Novo Nordisk’s business is driven by the Triple Bottom Line: a
commitment to economic success, environmental soundness, and social
responsibility to employees and customers. With headquarters in Denmark,
Novo Nordisk employs approximately 26,550 employees in 80 countries, and
markets its products in 179 countries. Novo Nordisk’s B shares are listed
on the stock exchanges in Copenhagen and London. Its ADRs are listed on the
New York Stock Exchange under the symbol ‘NVO’. For global information,
visit novonordisk.com; for United States information, visit
SOURCE Novo Nordisk