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Novo Nordisk A/S (NVO)'s Liraglutide Lowered Blood Sugar and Weight in African Americans With Type 2 Diabetes, Phase 3 Data Showed



7/27/2009 9:42:47 AM

LAS VEGAS, NV--(Marketwire - July 25, 2009) - Novo Nordisk (NYSE: NVO) data presented today showed that when taken by itself, once-daily liraglutide, an investigational treatment for type 2 diabetes, leads to statistically significant and sustained reductions in blood sugar and weight in African Americans with type 2 diabetes, as compared to glimepiride, a commonly prescribed diabetes treatment. The data were presented at the 114th National Medical Association Annual Convention & Scientific Assembly.

African Americans are 1.6 times more likely to have diabetes than non-Hispanic whites, and almost 15% of all African Americans aged 20 years or older have diabetes. In the study, 64% of African American patients treated with liraglutide 1.8 mg once a day and 29% treated with liraglutide 1.2 mg once daily reached and maintained the ADA's blood sugar target, versus 11% of patients treated with glimepiride 8 mg once daily after 52 weeks. The ADA's blood sugar target is an A1C, a measure of average blood sugar control over three months, of < 7%.

"Because African Americans are among the most affected by diabetes, it's important that we consider how these patients respond to potential treatments," said Dr. Mansur Shomali, Union Memorial Hospital, Baltimore, MD, and the lead author of the study. "In this study, liraglutide not only lowered blood sugar, but patients lost weight as well. This is good news for these patients who are often struggling to control their disease."

Study Results

In addition to lowering blood sugar, after 52 weeks of treatment with 1.8 mg of liraglutide, mean body weight decreased by 2.98 kg (or 6.57 lbs), and with 1.2 mg of liraglutide, mean body weight decreased by 0.71 kg (or 1.54 lbs), compared to a slight decrease in weight in the glimepiride group of 0.50 kg (or 1.10 lbs).

"Obesity is a major medical risk factor for type 2 diabetes and a significant issue in the African American community, as they are 1.4 times as likely to be obese as non-Hispanic whites," said Dr. Shomali. "For these patients in particular, even modest weight loss can make a significant difference in the management of their diabetes, which makes liraglutide a potentially important treatment option."

Rates of minor hypoglycemia, or low blood sugar, was lower for patients taking the 1.2 mg dose of liraglutide and statistically significantly lower for those taking the 1.8 mg dose of liraglutide versus glimepiride. Hypoglycemia is a common side effect of many of the commonly prescribed treatments and can cause dizziness or light-headedness, shakiness, confusion, and weakness, among other symptoms.

Study Results

                       Liraglutide       Liraglutide       Glimepiride
                       1.2 mg            1.8 mg            8 mg
                       N=34              N=30              N=30
                       ---------------   ---------------   ---------------
Baseline A1C, % (SD)         8.5 (0.86)        7.7 (0.99)        8.3 (0.98)
Change A1C, % (SE)          -0.8 (0.18)*      -1.2 (0.21)*      -0.2 (0.20)
                       ---------------   ---------------   ---------------
% A1C < 7%                        29.0              64.3              10.7
                       ---------------   ---------------   ---------------
Change weight, kg (SE)     -0.71 (0.86)      -2.98 (0.94)      -0.50 (0.93)
                       ---------------   ---------------   ---------------
Change fasting plasma
 glucose, mg/dL (SE)      -16.50 (9.79)      -43.8 (7.53)      -32.1 (7.83)
                       ---------------   ---------------   ---------------
Change post-prandial
 glucose, mg/dL (SE)       -40.5 (7.67)      -48.8 (7.53)      -32.1 (7.83)
                       ---------------   ---------------   ---------------
Reporting minor hypo
 events %                           12                10                30
Per subject-year                  0.45             0.28*              2.17
                       ---------------   ---------------   ---------------
Reporting nausea (%)              26.5                20               6.7
                       ---------------   ---------------   ---------------

*P < 0.05 vs glimepiride.

Safety and Tolerability of Liraglutide

The most common gastrointestinal-related adverse events were nausea, which was transient, diarrhea, and vomiting. Other adverse events reported included flu-like symptoms.

About the Study

The data presented looked at 94 patients from the United States or Mexico from the LEAD™ 3 monotherapy study, who self-identified as Black/African American. LEAD™ 3 is one of five studies that make up the phase 3 program for liraglutide.

The LEAD™ (Liraglutide Effect and Action in Diabetes) program comprised five randomized, controlled, double-blinded studies plus one open-label head-to-head study against exenatide and involved nearly 6,500 patients with type 2 diabetes in more than 40 countries.

The double-blinded, double-dummy, randomized, parallel group, actively controlled, multicenter, multinational, 52-week trial compared the efficacy and safety of two doses of liraglutide (1.2 and 1.8 mg once daily) to glimepiride (8 mg once daily) in patients with type 2 diabetes treated with diet/exercise or not more than half the maximum dose of one OAD for greater than or equal to two months. Patients treated with diet and exercise had an A1C between 7.0% and 11.0%. Patients previously treated with oral monotherapy had an A1C between 7.0% and 10.0%.

About Liraglutide

Once-daily liraglutide is the first human glucagon-like peptide-1 (GLP-1) analog developed for the treatment of type 2 diabetes. Liraglutide works by stimulating the release of insulin only when blood sugar levels are high. Weight loss with liraglutide is attributed to the fact that it slows gastric emptying and leads to increased satiety after meals. Liraglutide is naturally broken down in the body and does not require renal excretion.

On May 23, 2008, Novo Nordisk submitted a New Drug Application to the Food and Drug Administration (FDA) in the United States, as well as a marketing authorization application to the European Medicines Agency (EMEA), for the approval of liraglutide for the treatment of people with type 2 diabetes. A New Drug Application was also submitted for approval in Japan on July 14, 2008.

On July 3, 2009, Novo Nordisk announced that the European Commission granted marketing authorization for Victoza® (liraglutide) for the treatment of type 2 diabetes in adults. The authorization covers all 27 European Union member states.

In the United States, a regulatory decision is pending.

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 hemostasis 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 27,900 employees in 81 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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