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Sanofi Announces Positive Phase 3 Results for Investigational New Insulin U300
Date:6/22/2013

us mealtime insulin. In a multicenter, open-label study 807 people were randomized (1:1) to once daily evening new insulin U300 (n=404) or Lantus® (n=403) while continuing mealtime insulin. The basal insulin was titrated to achieve fasting plasma glucose of 80-100 mg/dL. Primary endpoint was change in HbA1c from baseline to month 6, and main secondary endpoint was % of people with at least 1 severe or confirmed (less than or equal to 70 mg/dL) nocturnal hypoglycemic event from month 3 to month 6.

EDITION I demonstrated similar reductions in HbA1c (glycated hemoglobin) from baseline (primary endpoint) between new insulin U300 and Lantus® at 6 months [least squares mean change -0.83% (0.06) in both groups; difference -0.00% (95% CI -0.11 to 0.11)] in people with type 2 diabetes who had challenging treatment needs (mean age of study participants: 60 years; duration of type 2 diabetes: 15.8 years; BMI: 36.6 kg/m2; HbA1c: 8.15 %; total insulin dose: 1.2 U/kg; basal insulin dose: 0.67 U/kg at baseline). In addition, approximately 40% of study participants with uncontrolled glycemic (blood sugar) levels despite receiving a combined therapy (oral antidiabetic agents plus basal and prandial insulins) reached glycemic control (HbA1c <7%) at month 6 both in the new insulin U300 (39.6%) and in the Lantus® arm (40.9%).

The investigational new insulin U300 was associated with a 21% reduction in severe or confirmed nocturnal hypoglycemia (low blood sugar) from month 3 to month 6. Significantly fewer patients had nocturnal (severe and/or confirmed; i.e. less than or equal to 70 mg/mL) hypoglycemia (low blood sugar) during months 3 to 6 (pre-specified main secondary endpoint: 36.1% vs. 46.0%; RR 0.79; p=0.0045) and the occurrence of any nocturnal hypoglycemic event (% of people with at least one event) during the 6-month study period was lower on new
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