Two-Year Data Show Investigational Drug Liraglutide More Effective at Lowering Blood Sugar Than Glimepiride: Oral 162

NEW ORLEANS, June 7  /PRNewswire-FirstCall/ -- Novo Nordisk (NVO) data presented today 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