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Novo Nordisk New Data From a Phase 3 Study Confirms Clinical Benefits of Once-Daily Liraglutide in the Management of Type 2 Diabetes
Date:9/8/2008

Liraglutide Liraglutide

1.2 mg + 1.8 mg + Placebo +

metformin + metformin + metformin +

rosiglitazone rosiglitazone rosiglitazone

N=178 N=178 N=177

Final HbA1c, %

Change HbA1c from 7.0 7.1 7.9

baseline % points -1.48* -1.48* -0.5

% HbA1c achieving

<7.0% 58* 54* 28

% HbA1c achieving

< or = 6.5% 36* 37* 14

Mean change in weight

from baseline, kg -1.02* -2.02 0.60

Mean change in

FPG from baseline,

mmol/L -2.2* -2.4* -0.4

Mean change in

PPG from baseline,

mmol/L -2.6 -2.7* -0.8

% reporting minor

hypoglycemic 9 8 5

events/subject/year 0.38 0.64* 0.17

Mean change in

systolic blood

pressure from

baseline, mmHg -6.7* -5.6* -1.1

*p<0.05 versus placebo

FPG, fasting plasma glucose; OAD, oral antidiabetic drug; PPG,

post-prandial glucose

Safety and tolerability of liraglutide

There were no major hypoglycemic episodes reported during the study. The rate of minor hypoglycemia (<3.1 mmol/L) was low in all groups (0.38, 0.64 and 0.17 events per subject year with liraglutide 1.2 mg, 1.8 mg and placebo, respectively). The most frequent adverse event was nausea, which was reported by 29-40% of patients treated with 1.2 mg and 1.8 mg respectively. However, nausea levels decreased to the same as the placebo group after the first 16 week
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SOURCE Novo Nordisk
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