Two-Year Data Show Investigational Drug Liraglutide More Effective at Lowering Blood Sugar Than Glimepiride

Update: Victoza (liraglutide) Now FDA Approved - January 25, 2010

NEW ORLEANS, June 8 /PRNewswire-FirstCall/ -- Novo Nordisk (NVO) data presented at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA) showed that once-daily liraglutide, taken as monotherapy, leads to statistically significant and sustained reductions in blood sugar and weight after two years of treatment.
 

In the study, 58% of patients treated with liraglutide 1.8 mg once daily reached and maintained the ADA's blood sugar target of A1C less than 7% versus 37% of patients treated with glimepiride 8 mg once daily.
 

"The fact that liraglutide continues to effectively lower blood sugar after two years of treatment is consistent with its other long-term clinical benefits such as continued reductions in fasting blood sugar and weight," said, Dr. Alan Garber, Baylor College of Medicine, Houston, a LEAD(TM) 3 principal study investigator. "Even with available treatments, many type 2 diabetes patients still struggle to control their blood sugar, while losing weight. Liraglutide represents an important advance for these patients."
 

The LEAD(TM) 3 extension study also documented that treatment with liraglutide leads to early and lasting weight loss. Many currently available diabetes treatments lead to weight gain, a concern for type 2 diabetes patients, most of whom are already overweight. After two years of treatment with 1.8 mg of liraglutide, mean body weight decreased significantly (-2.7 kg) compared to overall weight increase in the glimepiride group (+1.1 kg).
 

Hypoglycemia is a condition where blood sugar levels become too low. Minor hypoglycemia was more than six times less frequent in the liraglutide treatment groups compared with the glimepiride group.
 

About LEAD(TM) 3 Extension
 

The LEAD(TM) 3 Extension compared the efficacy and safety of liraglutide (1.8 mg and 1.2 mg, once daily) to glimepiride (8 mg, once daily) in patients with type 2 diabetes. Patients were treated previously with diet/exercise or low doses of one oral antidiabetic drug (OAD). The trial had a 52-week randomized, double-blind period followed by the one year extension; 59% entered the extension period of the trial and 43% of these patients completed the full two-year study period.
 

  LEAD(TM) 3: two-year data


  Two years                Liraglutide       Liraglutide       Glimepiride
   monotherapy             1.8 mg, QD        1.2 mg, QD        8 mg, QD
                           N=154             N=149             N=137

  Diabetes duration,
   years at baseline         5.0                5.0              5.0

  Previous treatment:
  % diet/exercise             35%                38%              34%
  % OAD monotherapy           65%                62%              66%

  A1C % at baseline          8.1                8.1              8.0

  BMI, kg/m(2) at
   baseline                   33                 33               33

  Change in A1C% from
   baseline                 -1.1               -0.9             -0.6

  Change in A1C%  from
   baseline (in
   patients with <3
   years' duration of
 diabetes) -1.4 -1.1 -0.7

 % a1c <7.0% 58 53 37

 change fpg (fasting
 plasma glucose)
 mg>

The rate of minor hypoglycemia was statistically significantly lower with both liraglutide dose groups compared to the glimepiride-treated group. The most common gastrointestinal-related adverse events were nausea, diarrhea and vomiting, and most were transient. Other adverse events reported included flu-like symptoms.
 

About LEAD(TM) (Liraglutide Effect and Action in Diabetes)
 

The LEAD(TM) program comprises five randomized, controlled, double-blinded studies plus one open-label head-to-head study against exenatide and involved more than 4,000 patients with type 2 diabetes in 40 countries.
 

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 U.S., 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 April 23, 2009, Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) under the EMEA adopted a positive opinion, recommending marketing authorization of liraglutide for treatment of type 2 diabetes in Europe.
 

In the U.S., 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.
 

Source: Novo Nordisk

CONTACT: Media: Elin K. Hansen, +45-4442-3450, ekh@novonordisk.com; In
North America: An Phan, +1-609-558-0420, anph@novonordisk.com; Investors: Mads
Veggerby Lausten, +45-4443-7919, mlau@novonordisk.com, Kasper Roseeuw Poulsen,
+45-4442-4471, krop@novonordisk.com, or Hans Rommer, +1-609-919-7937,
hrmm@novonordisk.com
 

Web Site: http://www.novonordisk.com

Posted: June 2009

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