Data from One-year Liraglutide Phase 3 Study Published in The Lancet
- Data to be published in The Lancet highlights benefits of early treatment of novel type 2 diabetes treatment
- Liraglutide shows significant and sustained benefits for treatment naive patients
- Phase III data demonstrates effective blood-sugar control and weight loss for patients
COPENHAGEN, Denmark, Sept. 25, 2008--Data from a 52-week phase 3 study (LEAD™ 3) of liraglutide, a once-daily human GLP-1 analogue, were published today by 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 antidiabetic drug.1 Moreover, the treatment with liraglutide leads to weight loss, reduced systolic blood pressure and lower rates of hypoglycaemia after 52 weeks of treatment.1
“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 glycaemic 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-naïve 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.1
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 hypoglycaemic episodes reported during the study. The rate of minor hypoglycaemia was statistically significantly lower in both liraglutide dose groups compared with the glimepiride-treated group. The most common gastrointestinal-related adverse events were nausea, diarrhea, and vomiting in the liraglutide arms and most were transient.1 Other adverse events reported included flu-like symptoms.
Liraglutide is a once-daily human analogue 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 23 May 2008, Novo Nordisk submitted a New Drug Application to the Food and Drug Administration in the United States as well as a marketing authorisation 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 14 July 2008.
About LEAD™ (Liraglutide Effect and Action in Diabetes)
The data published early online and in an upcoming edition of The Lancet is from the LEAD™ 3 study, one of five randomised, controlled, double-blinded studies that make up the phase 3a programme for liraglutide. The phase 3a programme involved about 4,000 patients with type 2 diabetes in 40 countries.
Data from the LEAD™ 3 study has previously been reported on by Novo Nordisk in a Stock Exchange Announcement on 11 December 2007, and in a press release on 9 June 2008, in connection with the American Diabetes Association meeting in San Francisco.
Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. 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 more information, visit novonordisk.com.
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Garber A, Henry R, Ratner R et al. Liraglutide as compared to glimepiride monotherapy in a 52-week, phase 3 study of subjects with type 2 diabetes: LEAD-3 (mono). Lancet. 2008.
Posted: September 2008