Sanofi-Aventis Presents Results For Head-to-Head Study Of Lantus

Published: 30-Sep-2009

Superior efficacy-dose ratio for Lantus over Detemir

Sanofi-Aventis has announced the results of a head-to-head study of once-daily, 24-hour basal insulin Lantus compared to twice-daily insulin Detemir.

The study was a head-to-head, randomised, non-inferiority controlled clinical trial of 964 patients, patients taking Lantus required an average daily dose of 43.5 units to achieve the primary endpoint of HbA1c below 7% without symptomatic hypoglycaemia compared to patients on insulin Detemir, who received 76.5 units - an increase of 76% (p<0.001).

Despite lower doses of insulin in the glargine group, Lantus once-daily and insulin Detemir twice-daily resulted in similar improvements in glycemic control (HbA1c) and a similar risk of hypoglycaemia (primary endpoint: 27.5% vs 25.6%, p=0.52). Patients in the Lantus arm of the study also achieved significantly lower fasting blood glucose (-63.1mg/dl Lantus vs -57.7mg/dl, p<0.001).

In the study, patients taking Lantus 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 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 1.4kg, difference 0.77 kg, p<0.001).

Hertzel Gerstein, study investigator, and professor of diabetes medicine at Faculty of health sciences, Hamilton, Canada, said: "This study demonstrated that for insulin-naive patients with type 2 diabetes, initiating insulin therapy with once-daily glargine achieved the same glycemic control as twice-daily Detemir, with somewhat more weight gain, but lower insulin dose."

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