Two-Year Data Show Investigational Drug Liraglutide More Effective at Lowering Blood Sugar Than Glimepiride
June 08 2009 - 7:00AM
PR Newswire (US)
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