In the study, patients taking Lantus(R) once-daily reported a significantly greater treatment satisfaction over insulin detemir twice-daily, with over 50% less drop-outs (4.6% vs 10.1%, p=0.001). Discontinuations in patients taking insulin detemir were primarily due to adverse events, including skin reactions. Whilst a similar rate of overall hypoglycaemia and nocturnal hypoglycaemia was observed in both arms, patients on Lantus(R) once-daily experienced less daytime hypoglycaemia as compared to insulin detemir (1.06 vs 1.64 events per patient year, p=0.046). Patients on insulin detemir experienced less weight gain (0.6 vs 1.4 kg, difference 0.77 kg, p<0.001).
About the Lantus(R) vs. insulin detemir study(1)
In the study, a total of 964 insulin-naive patients were examined. Patients were between 40 to 75 years of age and had type 2 diabetes for at least 1 year with sub-optimal blood glucose control using glucose-lowering drugs.
Patients were randomised and treated with Lantus(R) once daily, at either dinner or bedtime, or insulin detemir twice daily, both at breakfast and before dinner, along with stable doses of metformin. Thiazolidinedione treatment was halted as of insulin randomisation, but insulin secretagogues were continued or discontinued at the investigator's discretion.
For both insulins, the starting daily dose was 0.2 U/kg, which was then
titrated every 2 days by 2 units to obtain a Fasting Plasma Glucose (FPG) of
<100 mg/dL (5.6 mmol/L). At baseline, mean age was 58.4 plus or minus 8.3 yrs
(mean plus or minus standard deviation), mean type 2 diabetes duration was
9.9 plus or minus 5.8 years, mean FPG was 189.2 plus or minus 48.7 mg/dL, and
mean HbA1c was 8.7 plus or minus 0.9%. 27.5% and 25.6% of patients reached
the primary endpoint of HbA1c <7% without confirmed hypoglycaemia. Change
from baseline to endpoint HbA1c w
|SOURCE Sanofi Aventis Groupe|
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