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Superior Efficacy-dose Ratio for Lantus(R) Over detemir
Date:9/30/2009

PARIS, September 30 /PRNewswire-FirstCall/ --

- 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.

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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<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%, p=0.52). Patients in the Lantus(R) arm of the study also achieved significantly lower fasting blood glucose (-63.1 mg/dL Lantus(R) vs -57.7 mg/dL, p<0.001).

"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
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SOURCE Sanofi Aventis Groupe
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