Sanofi-aventis announces study results comparing efficacy of Lantus to detemir

- 76% Higher Dose of Insulin detemir Needed to Achieve Similar, Well Tolerated Glycemic Control Versus Lantus(R)

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today results of a head-to-head study providing further evidence on the efficacy of once-daily, 24-hour basal insulin Lantus(R) (insulin glargine (rDNA) injection) compared to twice-daily insulin detemir. The study was presented during the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna.

In the head-to-head, randomised, non-inferiority controlled clinical trial of 964 patients, patients taking Lantus(R) 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(less than)0.001). Despite lower doses of insulin in the glargine group, Lantus(R) 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%,>

"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 doses", stated Study Investigator Hertzel Gerstein, Professor of Diabetes Medicine, Faculty of health sciences, Hamilton, Canada.

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%,>

Source:

SANOFI AVENTIS GROUPE

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