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

insulin U300 during the study period compared to the Lantus® group (45.3% vs. 59.7%; RR 0.76; 95% CI 0.66 to 0.87). New insulin U300 was well-tolerated in this study, with no differences in other adverse events observed from Lantus®.

The EDITION I abstract is titled: New Insulin Glargine Formulation: Glucose Control and Hypoglycemia in People with Type 2 Diabetes Using Basal and Mealtime Insulin (EDITION I) (Riddle, MC et al) [Abstract no. 43-LB]EDITION II Topline results of EDITION II are consistent with EDITION I findings. EDITION II demonstrated that investigational new insulin U300 achieved similar blood sugar reduction while fewer patients experienced night-time low blood sugar events compared with Lantus®.

EDITION II evaluated efficacy and safety of new insulin U300 in a type 2 diabetes population (811 patients) treated with basal insulin plus oral antidiabetic therapy. The full EDITION II results will be submitted for presentation at upcoming scientific meetings.

"There remains a substantial unmet need in people with diabetes taking oral medication or insulin as many of them do not reach their glycemic goals," said Pierre Chancel, Senior Vice President, Global Diabetes, Sanofi. "With the investigational new insulin U300, we are striving to further enhance the clinical value of basal insulin, while building on the wealth of evidence of Lantus®, the world's most prescribed insulin."

About investigational new insulin U300Investigational new insulin U300 is a new formulation based on the glargine molecule, the biological entity of Lantus®, with its well established efficacy and safety profile. However, new insulin U300 has unique pharmacokinetic and pharmacodynamic profiles with studies demonstrating it has even flatter and more prolonged profiles than Lantus®.1,2 New insulin U300 also offers the benef
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