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EASD: Superior Efficacy-Dose Ratio for Lantus® over Detemir

Oct 4, 2009

Seventy-six percent higher dose of insulin detemir needed to achieve similar, well tolerated glycemic control versus Lantus®.

Sanofi-aventis announced results of a head-to-head study providing further evidence on the efficacy of once-daily, 24-hour basal insulin Lantus® (insulin glargine [rDNA] injection) compared to twice-daily insulin detemir.

In the 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 (-63.1 mg/dL Lantus® vs. -57.7 mg/dL, p<0.001).

Study Investigator Hertzel Gerstein, Professor of Diabetes Medicine, Faculty of health sciences, Hamilton, Canada, stated that, “This study demonstrated that for insulin-naïve 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.”

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. 1.4 kg, difference 0.77 kg, p<0.001).

The study was presented during the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna.